Greater Manchester EUR Policy Statement on: Surgical management of ( tie) GM Ref: GM050 Version: 2.0 (16 September 2020)

Commissioning Statement

Surgical management of Ankyloglossia (tongue tie)

Policy This policy applies to children before their 18th Birthday. Exclusions (Alternative Frenuloplasty is commissioned for babies with fusion of the tongue to the floor of the commissioning mouth. arrangements apply) Treatment/procedures undertaken as part of an externally funded trial or as a part of locally agreed contracts / or pathways of care are excluded from this policy, i.e. locally agreed pathways take precedent over this policy (the EUR Team should be informed of any local pathway for this exclusion to take effect).

Policy Frenectomy for infants with feeding problems Inclusion Division of the frenulum should only be conducted when: Criteria  The infant is under 3 months of age at the time of referral AND  There are perceived difficulties AND  Mother and baby have been have been assessed by a health visitor or midwife with specialist expertise in feeding who have confirmed tongue tie as the likely cause of the problem

NOTE: Frenectomy to address the above should be performed as an outpatient procedure or within a suitable community service.

Onward referral to Tier 2 or Secondary care  If referral is to a tier 2 or secondary care provider then all of the points above should apply AND  An assessment of the degree of ankyloglossia should have been carried out by an appropriately trained clinician (usually midwife or health visitor) using the Hazelbaker Assessment Tool (see Appendix 3) which gives a score of less than or equal to 11

If a bottle fed infant has feeding issues related to tongue tie, then an Individual Funding Request application should be made – if the infant is failing to thrive, this must be marked URGENT.

Funding Mechanisms: Breast fed infants: Monitored approval: Referrals may be made in line with the criteria without seeking funding. NOTE: May be the subject of contract challenges and/or audit of cases against commissioned criteria. Bottle Fed Infants: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence. If the infant is failing to thrive, this must be marked URGENT.

GM Tongue Tie Policy v2.0 FINAL Page 2 of 23 Frenectomy for older children with speech problems In rare cases a tight frenulum may lead to speech problems. Where this is suspected the child should be assessed by speech and language services to ensure that there is no other underlying diagnosis that is interfering with the child’s language development.

In the case of these older children an application for exceptionality is required prior to referral for frenectomy.

The application should include:  A written assessment from a speech and language therapist stating that they believe the tongue tie to be a significant contributor to the speech problem(s).  A score of the degree of tongue tie using the Kotlow Classification of tongue tie (ankyloglossia)

If the referral is from a specialist service the tongue range of motion ratio can be given instead.

Funding Mechanism: Individual funding request (exceptional case) approval: Requests must be submitted with all relevant supporting evidence.

Tongue tie and folic acid In the development of this policy a search was carried out to find evidence linking tongue tie and folic acid. Most of the information found was anecdotal and there was no strong evidence for an association between tongue tie and the use of folic acid before or during pregnancy. This policy supports the use of folic acid in line with the Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017) (this is summarised at the end of Appendix 1 for ease of referral).

Clinical Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if Exceptionality they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

GM Tongue Tie Policy v2.0 FINAL Page 3 of 23 Contents

Commissioning Statement ...... 2 Policy Statement...... 5 Equality & Equity Statement ...... 5 Governance Arrangements ...... 5 Aims and Objectives ...... 5 Rationale behind the policy statement ...... 6 Treatment / Procedure ...... 6 Epidemiology and Need ...... 6 Adherence to NICE Guidance ...... 6 Audit Requirements ...... 7 Date of Review ...... 7 Glossary ...... 7 References ...... 7 Governance Approvals ...... 8 Appendix 1 – Evidence Review ...... 9 Appendix 2 – Clinical Coding – ICD10/OPCS4 ...... 19 Appendix 3 – Hazelbaker Assessment Tool for Lingual Frenulum Function ...... 20 Appendix 4 – Version History ...... 22

GM Tongue Tie Policy v2.0 FINAL Page 4 of 23 Policy Statement

The GM Effective Use of Resources (EUR) Policy Team, in conjunction with the GM EUR Steering Group, have developed this policy on behalf of Clinical Commissioning Groups (CCGs) within Greater Manchester, who will commission treatments/procedures in accordance with the criteria outlined in this document.

In creating this policy the GM EUR Steering Group has reviewed this clinical condition and the options for its treatment. It has considered the place of this treatment in current clinical practice, whether scientific research has shown the treatment to be of benefit to patients, (including how any benefit is balanced against possible risks) and whether its use represents the best use of NHS resources.

This policy document outlines the arrangements for funding of this treatment for the population of Greater Manchester.

This policy follows the principles set out in the ethical framework that govern the commissioning of NHS healthcare and those policies dealing with the approach to experimental treatments and processes for the management of individual funding requests (IFR).

Equality & Equity Statement

CCGs have a duty to have regard to the need to reduce health inequalities in access to health services and health outcomes achieved, as enshrined in the Health and Social Care Act 2012. CCG s are committed to ensuring equality of access and non-discrimination, irrespective of age, gender, disability (including learning disability), gender reassignment, marriage and civil partnership, pregnancy and maternity, race, religion or belief, gender or sexual orientation. In carrying out its functions, CCGs will have due regard to the different needs of protected characteristic groups, in line with the Equality Act 2010. This document is compliant with the NHS Constitution and the Human Rights Act 1998. This applies to all activities for which they are responsible, including policy development, review and implementation.

In developing policy the GM EUR Policy Team will ensure that equity is considered as well as equality. Equity means providing greater resource for those groups of the population with greater needs without disadvantage to any vulnerable group.

The Equality Act 2010 states that we must treat disabled people as more equal than any other protected characteristic group. This is because their ‘starting point’ is considered to be further back than any other group. This will be reflected in CCGs evidencing taking ‘due regard’ for fair access to healthcare information, services and premises.

An Equality Impact Assessment has been carried out on the policy. For more information about the Equality Impact Assessment, please contact [email protected]

Governance Arrangements

The Greater Manchester Joint Commissioning Board has given delegated authority to the Greater Manchester Directors of Commissioning and Directors of Finance to approve GM EUR treatment policies for implementation. Further details of the governance arrangements can be found in the GM EUR Operational Policy.

Aims and Objectives

This policy document aims to ensure equity, consistency and clarity in the commissioning of treatments/procedures by CCGs in Greater Manchester by:

GM Tongue Tie Policy v2.0 FINAL Page 5 of 23  reducing the variation in access to treatments/procedures.  ensuring that treatments/procedures are commissioned where there is acceptable evidence of clinical benefit and cost-effectiveness.  reducing unacceptable variation in the commissioning of treatments/procedures across Greater Manchester.  promoting the cost-effective use of healthcare resources.

Rationale behind the policy statement

In most cases the degree of tongue tie does not cause the individual any problems however in some cases it can interfere with breast feeding and in rare cases with speech development in older children. This policy aims to target the resource available to manage tongue tie to those cases that gain the most benefit.

Treatment / Procedure

Ankyloglossia Ankyloglossia, also known as tongue-tie, is a congenital anomaly characterised by an abnormally short lingual frenulum, which may restrict mobility of the tongue. It varies in degree, from a mild form in which the tongue is bound only by a thin to a severe form in which the tongue is completely fused to the floor of the mouth. Breastfeeding difficulties may arise as a result of the inability to suck effectively, causing sore and poor infant weight gain. If necessary, tongue-tie can be treated with a surgical cut to release the frenulum (frenotomy). If additional repair is needed or the lingual frenulum is too thick for frenotomy, a more extensive procedure known as frenuloplasty is used.

Tongue-tie is usually diagnosed on examination of the mouth. For infants, the doctor might use the Hazlebaker assessment tool to score various aspects of the tongue's appearance and ability to move.

This policy is concerned with the issues associated with the lingual frenulum when it is shorter and thicker than usual and can cause issues with breast feeding and in some instances difficulty with speech.

Frenectomy If division of the tongue-tie is performed in early infancy, it is usually performed without anaesthesia, although local anaesthetic is sometimes used. In an older infant or child, however, general anaesthesia is usually required. The baby is swaddled and supported at the shoulders to stabilise the head and sharp, blunt-ended scissors are used to divide the lingual frenulum. There should be little or no blood loss and feeding may be resumed immediately.

Frenuloplasty The release of the tissue (lingual frenulum) that attaches the tongue to the floor of the mouth and closure of the wound with stitches. It is the preferred surgery for tongue-tie in a child older than 1 year of age.

Epidemiology and Need

Tongue-tie is present in 4% to 11% of newborns.

Adherence to NICE Guidance

The policy adheres to NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding.

GM Tongue Tie Policy v2.0 FINAL Page 6 of 23 Audit Requirements

There is currently no national database. Service providers will be expected to collect and provide audit data on request.

Date of Review

Five years from the date of the last review, unless new evidence or technology is available sooner .

The evidence base for the policy will be reviewed and any recommendations within the policy will be checked against any new evidence. Any operational issues will also be considered at this time. All available additional data on outcomes will be included in the review and the policy updated accordingly. The policy will be continued, amended or withdrawn subject to the outcome of that review.

Glossary

Term Meaning

Ankyloglossia Tongue tie

Congenital anomaly An abnormality in anatomy present at birth.

Folic acid A vitamin of the B complex found especially in leafy green vegetables, liver, and kidney.

Frenotomy A simple splitting (cutting) of the frenulum.

Frenuloplasty A more complex procedure to release the tongue from the floor of the mouth where the tongue is fully attached.

Frenulotomy A surgical procedure for excising a frenum or frenulum.

Frenulum A small fold or ridge of tissue which supports or checks the motion of the part to which it is attached.

Fusion Joining together of tissues or organs.

Lingual frenulum The vertical fold of mucous membrane under the tongue.

Swaddled Having wrapped (someone, especially a baby) in garments or cloth.

Tongue tie When the frenulum linguae is shorter (and may be thicker) than normal preventing normal movement of the tongue.

References 1. GM EUR Operational Policy 2. The Cochrane Database of Systematic Reviews 2013-4-2: Folic acid supplementation during pregnancy for maternal health and pregnancy outcomes, Zohra S Lassi et al 3. Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017) - extract cited below evidence review

GM Tongue Tie Policy v2.0 FINAL Page 7 of 23 Governance Approvals

Name Date Approved

Greater Manchester Effective Use of Resources Steering Group 19/09/2018

Greater Manchester Directors of Commissioning / Greater Manchester Chief 29/08/2019 Finance Officers (Delegated authority given to approve policy by Greater Manchester Joint Commissioning Board)

Bolton Clinical Commissioning Group 13/09/2019

Bury Clinical Commissioning Group 29/08/2019

Heywood, Middleton & Rochdale Clinical Commissioning Group 29/08/2019

Manchester Clinical Commissioning Group 29/08/2019

Oldham Clinical Commissioning Group 29/08/2019

Salford Clinical Commissioning Group 29/08/2019

Stockport Clinical Commissioning Group 29/08/2019

Tameside & Glossop Clinical Commissioning Group 29/08/2019

Trafford Clinical Commissioning Group 29/08/2019

Wigan Borough Clinical Commissioning Group 29/08/2019

GM Tongue Tie Policy v2.0 FINAL Page 8 of 23 Appendix 1 – Evidence Review Surgical management of Ankyloglossia (tongue tie) GM050

Search Strategy

The following databases are routinely searched: NICE Clinical Guidance and full website search; NHS Evidence and NICE CKS; SIGN; Cochrane; York; and the relevant Royal College and any other relevant bespoke sites. A Medline / Open Athens search is undertaken where indicated and a general google search for key terms may also be undertaken. The results from these and any other sources are included in the table below. If nothing is found on a particular website it will not appear in the table below:

Database Result

NICE NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding (Published: 14 Dec 2005)

DARE (was York) Prevalence, diagnosis, and treatment of ankyloglossia a Methodologic review, L M. Segal et al Can Fam Physician 2007;53:1027-1033

Cochrane Frenotomy for tongue-tie in newborn infants, O’Shea JE, Foster JP, O’Donnell CPF, Breathnach D, Jacobs SE, Todd DA, Davis PG, Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD011065.

NICE Evidence Treatments for ankyloglossia and ankyloglossia with concomitant -tie, Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML., Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 149. 2015

Treatment of Ankyloglossia for Reasons Other Than Breastfeeding: A Systematic Review, S Chinnadurai et al, Pediatrics, Volume 135, number 6, June 2015

Tongue-tie division. Is it worth it? A retrospective cohort study, S Braccio et al, British Journal of Midwifery, 2016, vol./is. 24/5(317-321), 09694900

RCM website Tongue-tied (Advice page) – indications for intervention as given on this page cited below

Summary of the evidence

Ankyloglossia (tongue tie) is relatively common, occurring in around 10% of babies. In most cases this causes no issues at all for the individual and is harmless. The evidence suggests that the following can be associated with tongue tie:  Maternal pain from feeding  Difficulties with latching and then feeding  Failure to thrive

There is also low level evidence for a slight association with speech and language difficulties in older children.

It appears that most babies with a degree of tongue tie can successfully breast feed if the mother receives support from a health visitor or midwife with specialist expertise in breast feeding. For a smaller group frenectomy may be needed for successful breast feeding. Complications of frenectomy are rare and manageable.

GM Tongue Tie Policy v2.0 FINAL Page 9 of 23

More extreme tongue tie where the tongue is tethered to the floor of the mouth will require surgical intervention. For this group frenuloplasty is the treatment of choice.

There is no evidence to support the current view that tongue tie is caused by folic acid supplements during pregnancy.

The evidence

Levels of evidence

Level 1 Meta-analyses, systematic reviews of randomised controlled trials

Level 2 Randomised controlled trials

Level 3 Case-control or cohort studies

Level 4 Non-analytic studies e.g. case reports, case series

Level 5 Expert opinion

1. LEVEL 1: NICE Interventional procedures guidance NICE IPG149: Division of ankyloglossia (tongue-tie) for breastfeeding (Published: 14 Dec 2005)

1 Guidance 1.1 Current evidence suggests that there are no major safety concerns about division of ankyloglossia (tongue-tie) and limited evidence suggests that this procedure can improve breastfeeding. This evidence is adequate to support the use of the procedure provided that normal arrangements are in place for consent, audit and clinical governance. 1.2 Division of ankyloglossia (tongue-tie) for breastfeeding should only be performed by registered healthcare professionals who are properly trained. 1.3 Publication of further controlled trials on the effect of the procedure on successful long -term breastfeeding will be useful. 2 The procedure 2.1 Indications 2.1.1 Ankyloglossia, also known as tongue-tie, is a congenital anomaly characterised by an abnormally short lingual frenulum, which may restrict mobility of the tongue. It varies from a mild form in which the tongue is bound only by a thin mucous membrane, to a severe form in which the tongue is completely fused to the floor of the mouth. Breastfeeding difficulties may arise, such as problems with latching (getting the mother and baby appropriately positioned to breastfeed successfully), sore nipples and poor infant weight gain. 2.1.2 Many tongue-ties are asymptomatic and cause no problems. Some babies with tongue-tie have breastfeeding difficulties. Conservative management includes breastfeeding advice, and careful assessment is important to determine whether the frenulum is interfering with feeding and whether its division is appropriate. Some practitioners believe that if division is required, this should be undertaken as early as possible. This may enable the mother to continue to breastfeed, rather than having to feed artificially. 2.2 Outline of the procedure 2.2.1 In early infancy, division of the tongue-tie is usually performed without anaesthesia, although local anaesthetic is sometimes used. The baby's head is stabilised, and sharp, blunt-ended scissors are used to divide the lingual frenulum. There should be little or no blood loss and feeding may be resumed immediately. After the early months of life, general anaesthesia is usually required. 2.3 Efficacy

GM Tongue Tie Policy v2.0 FINAL Page 10 of 23 2.3.1 One randomised controlled trial was reported, comparing division of tongue-tie with 48 hours of intensive support from a consultant. The study reported that 95% (19/20) of babies had improved breastfeeding 48 hours after tongue-tie division, compared with 5% (1/20) of babies in the control group (p < 0.001). 2.3.2 In one case-series, 80% (173/215) of babies had improved breastfeeding at 24 hours after the procedure. In another case-series, 100% (123/123) babies had an improved after the procedure and there was a significant decrease in maternal pain. In a third case-series, 100% (36/36) of babies had a normal tongue motion at 3 months. 2.3.3 Some of the Specialist Advisors stated that it is difficult to ascertain that any improvement in breastfeeding is actually due to the procedure. 2.4 Safety 2.4.1 Few adverse effects were reported. One case-series reported that 2% (4/215) of babies had an ulcer under the tongue for more than 48 hours and 0.5% (1/215) of babies had soreness for more than 24 hours. 2.4.2 Two studies, including a total of 159 babies, stated that there were no complications. Two studies reported that 8% (3/36) and 18% (39/215) of babies slept through the entire procedure. 2.4.3 The Specialist Advisors listed bleeding, infection, ulceration, pain, damage to the tongue and submandibular ducts, and recurrence of the tongue-tie as potential adverse effects of the procedure but several advisors stated that these were likely to be very rare events. List of studies included in the overview This overview is based on five studies (see references). One randomised controlled trial was reported, comparing division of tongue-tie with 48 hours of intensive support from a . 1 Three case-series were identified, including a total of 374 babies.2,3,4 One cross-over study, comparing division with a sham procedure, was reported as an abstract only. 5 Existing reviews on this procedure No systematic reviews on this procedure were identified. Validity and generalisability of the studies  The main outcome measures in four of the five studies were subjective and based on reports by the mother.1,2,3,5  The randomised controlled trial did not attempt to blind either the mother or the investigator as to which group the baby had been allocated to.1  The randomised controlled trial offered division to the control group after 48 hours because it was considered unethical to withhold this option, so there was no comparison to indicate whether any of the babies would have improved spontaneously.  The prospective cross-over trial was only reported as an abstract and included a small number of cases.5 Specialist advisors’ opinions Specialist advice was sought from consultants who have been nominated or ratified by their Specialist Society or Royal College.  Most of the advisors consider the procedure to be established practice.  A more common indication for this procedure is the treatment of speech difficulties in older children, when a general anaesthetic is used.  Careful case selection is important to ensure that only those tongue-ties that are likely to be causing problems are divided.  The current alternative treatment is breastfeeding advice and counselling from a lactation consultant.  Most of the advisors believe that the potential impact of this procedure on the NHS is minor. Issues for consideration by IPAC There appears to be considerable controversy regarding the significance of tongue tie in relation to breastfeeding difficulties and about the appropriate management of the condition .6

GM Tongue Tie Policy v2.0 FINAL Page 11 of 23 References 1 Hogan M, Westcott C, Griffiths M. A randomised, controlled trial of division of tongue-tie in infants with feeding problems. Journal of Paediatrics and Child Health; 2005: in press. 2 Griffiths DM. Do tongue ties affect breastfeeding? Journal of Human Lactation 2004; 20:409–14. 3 Ballard JL, Auer CE, Khoury JC. Ankyloglossia: assessment, incidence, and effect of frenuloplasty on the breastfeeding dyad. Pediatrics 2002; 110: e63. 4 Masaitis NS, Kaempf JW. Developing a frenotomy policy at one medical center: a case study approach. Journal of Human Lactation 1996; 12: 229–32. 5 Dolberg S, Botzer E, Grunis E et al. A randomized, prospective, blinded clinical trial with cross-over of frenotomy in ankyloglossia: effect on breast-feeding difficulties. Pediatric Research 2002; 52: 822. 6 Messner AH, Lalakea ML. Ankyloglossia: controversies in management. International Journal of Pediatric Otorhinolaryngology 2000; 54: 123–31.

2. LEVEL 1: REVIEW Prevalence, diagnosis, and treatment of ankyloglossia a Methodologic review, L M. Segal et al Can Fam Physician 2007;53:1027-1033

ABSTRACT Objective: To review the diagnostic criteria for, the prevalence of, and the effectiveness of frenotomy for treatment of ankyloglossia. Data Sources: MEDLINE and CINAHL databases were searched for articles suitable for a methodologic review of studies on various aspects of ankyloglossia. Study Selection: Studies that presented data on patients and addressed ankyloglossia in relation to breastfeeding were selected. Case reports, case series, retrospective studies, prospe ctive controlled studies, and randomized controlled trials were included in the analysis. Opinion pieces, literature reviews, studies without data on patients, studies that did not focus on breastfeeding, position statements, and surveys were excluded. Synthesis: There is no well-validated clinical method for establishing a diagnosis of ankyloglossia. Five studies using different diagnostic criteria found a prevalence of ankyloglossia of between 4% and10%. The results of 6 non-randomized studies and 1 randomized study assessing the effectiveness of frenotomy for improving nipple pain, sucking, latch, and continuation of breastfeeding all suggested frenotomy was beneficial. No serious adverse events were reported. Conclusion: Diagnostic criteria for ankyloglossia are needed to allow for comparative studies of treatment. Frenotomy is likely an effective treatment, but further randomized controlled trials are needed to confirm this. A reliable frenotomy decision rule is also needed.

3. LEVEL 1: SYSTEMATIC REVIEW Frenotomy for tongue-tie in newborn infants, O’Shea JE, Foster JP, O’Donnell CPF, Breathnach D, Jacobs SE, Todd DA, Davis PG, Cochrane Database of Systematic Reviews 2017, Issue 3. Art. No.: CD011065.

ABSTRACT Background: Tongue-tie, or ankyloglossia, is a condition whereby the lingual frenulum attaches near the tip of the tongue and may be short, tight and thick. Tongue-tie is present in 4% to 11% of newborns. Tongue-tie has been cited as a cause of poor breastfeeding and maternal nipple pain. Frenotomy, which is commonly performed, may correct the restriction to tongue movement and allow more effective breastfeeding with less maternal nipple pain. Objectives: To determine whether frenotomy is safe and effective in improving ability to feed orally among infants younger than three months of age with tongue-tie (and problems feeding). Also, to perform subgroup analysis to determine the following:  Severity of tongue-tie before frenotomy as measured by a validated tool (e.g. Hazelbaker Assessment Tool for Lingual Frenulum Function (ATLFF) scores < 11; scores ≥ 11) (Hazelbaker 1993).

GM Tongue Tie Policy v2.0 FINAL Page 12 of 23  Gestational age at birth (< 37 weeks’ gestation; 37 weeks’ gestation and above).  Method of feeding (breast or bottle).  Age at frenotomy (≤ 10 days of age; > 10 days to three months of age).  Severity of feeding difficulty (infants with feeding difficulty affecting weight gain (as assessed by infant’s not regaining birth weight by day 14 or falling off centiles); infants with symptomatic feeding difficulty but thriving (greater than birth weight by day 14 and tracking centiles). Search methods: We searched the Cochrane Central Register of Controlled Trials (CENTRAL), MEDLINE, Embase and CINAHL up to January 2017, as well as previous reviews including cross- references, expert informants and journal handsearching. We searched clinical trials databases for ongoing and recently completed trials. We applied no language restrictions. Randomised, quasi-randomised controlled trials or cluster-randomised trials that compared frenotomy versus no frenotomy or frenotomy versus sham procedure in newborn infants. Data collection and analysis: Review authors extracted from the reports of clinical trials data regarding clinical outcomes including infant feeding, maternal nipple pain, duration of breastfeeding, cessation of breastfeeding, infant pain, excessive bleeding, infection at the site of frenotomy, ulceration at the site of frenotomy, damage to the tongue and/or submandibular ducts and recurrence of tongue-tie. We used the GRADE approach to assess the quality of evidence. Main results: Five randomised trials met our inclusion criteria (n = 302). Three studies objectively measured infant breastfeeding using standardised assessment tools. Pooled analysis of two studies (n = 155) showed no change on a 10-point feeding scale following frenotomy (mean difference (MD) -0.1, 95% confidence interval (CI) -0.6 to 0.5 units on a 10-point feeding scale). A third study (n = 58) showed objective improvement on a 12-point feeding scale (MD 3.5, 95% CI 3.1 to 4.0 units of a 12-point feeding scale). Four studies objectively assessed maternal pain. Pooled analysis of three studies (n = 212) based on a 10-point pain scale showed a reduction in maternal pain scores following frenotomy (MD - 0.7, 95% CI -1.4 to -0.1 units on a 10-point pain scale). A fourth study (n = 58) also showed a reduction in pain scores on a 50-point pain scale (MD -8.6, 95% CI -9.4 to -7.8 units on a 50-point pain scale). All studies reported no adverse effects following frenotomy. These studies had serious methodological shortcomings. They included small sample sizes, and only two studies blinded both mothers and assessors; one did not attempt blinding for mothers nor for assessors. All studies offered frenotomy to controls, and most controls underwent the procedure, suggesting lack of equipoise. No study was able to report whether frenotomy led to long-term successful breastfeeding. Authors’ conclusions: Frenotomy reduced breastfeeding mothers’ nipple pain in the short term. Investigators did not find a consistent positive effect on infant breastfeeding. Researchers reported no serious complications, but the total number of infants studied was small. The small number of trials along with methodological shortcomings limits the certainty of these findings. Further randomised controlled trials of high methodological quality are necessary to determine the effects of frenotomy.

4. LEVEL 1: SYSTEMATIC REVIEW The effect of tongue-tie division on breastfeeding and speech articulation: a systematic review Webb AN, Hao W, Hong P.. International Journal of Pediatric Otorhinolaryngology 2013; 77(5): 635-646

CRD summary: This review concluded that tongue-tie division for ankyloglossia was well tolerated, and provided objective and subjective benefits for breastfeeding, but the evidence was limited. There were no significant data to suggest that ankyloglossia was a cause of speech articulation problems. These conclusions were appropriately cautious, but may be overly positive given the severe limitations of the included evidence. Authors' objectives: To systematically review the outcomes of tongue-tie division procedures for patients with ankyloglossia (tongue tie). Searching: MEDLINE, EMBASE, and The Cochrane Library were searched for relevant publications from 1966 to June 2012. Search terms were reported and reference lists of retrieved articles were hand searched for further relevant publications. No language restrictions were applied. Study selection: Two reviewers independently selected studies that reported measures of breastfeeding, speech, or adverse events, for patients who had undergone tongue-tie release. Case

GM Tongue Tie Policy v2.0 FINAL Page 13 of 23 series (with at least five patients), case-control studies, cohort studies, and randomised controlled trials were eligible for inclusion. Participants in the included studies were aged from one day to 23 years and underwent frenotomy (frenectomy; removal of the frenulum – tongue-tie tissue) or frenuloplasty (alteration of the frenulum), following a clinical diagnosis of ankyloglossia or breastfeeding problems. Where authors disagreed on study selection, a third reviewer was consulted. Assessment of study quality: Study quality was assessed on seven criteria: inclusion and exclusion criteria clearly stated; validated assessment method; appropriate comparison group (within -patient or control group); blinded observers; adequate sample size or power analysis; well-defined, consecutive sample; and less than 5% of participants lost at follow-up. The authors did not state how many reviewers performed this assessment. Data extraction: The data were extracted on study characteristics, with mean or median values, standard deviations, confidence intervals or probabilities, or several of these measures, extracted for quantitative outcomes. The authors did not state how many reviewers extracted the data. Methods of synthesis: The study results were combined in a narrative synthesis. Results of the review: Twenty studies (15 observational and five randomised controlled trials) with 1,012 participants were included. Studies met between two and six of the quality criteria. Tongue-tie division provided statistically significant objective improvements in Latch, Audible swallowing, Type of nipple, Comfort, and Hold (LATCH) scores (two studies), the Short Form McGill Pain Questionnaire (two studies), the Infant Breastfeeding Assessment Tool (one study), production and feeding characteristics (three studies), and infant weight gain (one study). Subjective improvements were reported for maternal perception of breastfeeding (14 studies) and maternal pain (four stud ies). No significant improvements in speech function were reported (four studies). Adverse events were infrequently reported, the most serious being the need for a repeat procedure. Authors' conclusions: Tongue-tie division was well tolerated and provided objective and subjective benefits for breastfeeding, but there was little high-quality evidence. There were no significant data to suggest that ankyloglossia was a cause of speech articulation problems. CRD commentary: This review attempted to identify evidence to address a broadly defined research question. Attempts were made to minimise bias and errors in the selection of studies, but it was not clear if such measures were taken for other processes. The diversity of the included studies suggests that a narrative synthesis was appropriate, but few details of the included studies were given. The authors' conclusions follow from the results found, but this evidence might be biased due to small samples, selected participant groups, subjective outcome measures, lack of blinding, and the absence of comparators. The discussion section of the review appeared to suggest that the largest (and highest quality) randomised study found no significant effect on LATCH score, but this study did not appear in the summary tables, nor in the narrative synthesis of results. Given the limitations of the primary evidence and the lack of clarity in some aspects of reporting, the authors' conclusions on the efficacy of tongue-tie division were appropriately cautious, but may be overly positive. Implications of the review for practice and research: Practice: The authors stated that tongue-tie division should only be performed by a trained healthcare professional, on newborns with significant ankyloglossia and associated breastfeeding problems, who had failed to respond to conservative management; it should not be used to prevent articulation problems. Research: The authors stated that long-term studies were needed and they should use validated measures of ankyloglossia severity and breastfeeding outcomes. Funding: No external funding received.

5. LEVEL 1: REVIEW Treatments for ankyloglossia and ankyloglossia with concomitant lip -tie, Francis DO, Chinnadurai S, Morad A, Epstein RA, Kohanim S, Krishnaswami S, Sathe NA, McPheeters ML., Rockville: Agency for Healthcare Research and Quality (AHRQ). Comparative Effectiveness Review No. 149. 2015

GM Tongue Tie Policy v2.0 FINAL Page 14 of 23 ABSTRACT Objectives: We systematically reviewed the literature on surgical and nonsurgical treatments for infants and children with ankyloglossia and ankyloglossia with concomitant lip-tie. Data sources: We searched MEDLINE® (PubMed®), PsycINFO®, Cumulative Index of Nursing and Allied Health Literature (CINAHL®) and Embase (Excerpta Medica Database), as well as the reference lists of included studies and recent systematic reviews. We conducted the searches between September 2013 and August 2014. Review methods: We included studies of interventions for ankyloglossia published in English. Two investigators independently screened studies against predetermined inclusion criteria and independently rated the quality of included studies. We extracted data into evidence tables and summarized them qualitatively. Results: We included 58 unique studies comprising 6 randomized controlled trials (RCTs) (3 good, 1 fair, 2 poor quality), 3 cohort studies (all poor quality), 33 case series, 15 case reports, and 1 unpublished thesis. Most studies assessed the effects of frenotomy (a procedure in which the lingual frenulum is divided) on breastfeeding-related outcomes. Four RCTs reported improvements in breastfeeding efficacy using either maternally reported or observer ratings, while two RCTs u sing observer ratings found no improvement. Mothers consistently reported improved breastfeeding effectiveness after frenotomy, but outcome measures were heterogeneous and short term. Future studies could provide additional data to confirm or change the measure of effectiveness; thus, we consider the strength of evidence (SOE; confidence in the estimate of effect) to be low at this time. Furthermore, this literature is characterized by (1) a lack of details about the surgical procedure, (2) cointerventions allowed variably in control groups, and (3) diversity of provider settings. Pain outcomes improved for mothers of frenotomized infants compared with control in one study of 6 -day old infants but not in studies of infants a few weeks older. Given these inconsistencies and the small number of comparative studies and participants, the SOE is low for an immediate reduction in nipple pain. Three studies with significant limitations reported improvements in other feeding outcomes with frenotomy, and four poor-quality studies reported some improvements in speech articulation but mixed results related to overall speech sound production. Three poor-quality comparative studies noted some improvements in social concerns and gains in tongue mobility in treated participants. SOE for all of these outcomes is insufficient. SOE is moderate for minor and short-term bleeding following surgery and insufficient for other harms (reoperation, pain). Conclusions: A small body of evidence suggests that frenotomy may be associated with improvements in breastfeeding as reported by mothers, and potentially in nipple pain, but with small short -term studies, inconsistently conducted, SOE is generally low to insufficient. Comparative studies reported improvements in some measures of speech, but assessment of outcomes was inconsistent. Few studies addressed tongue mobility and self-esteem issues. Research is lacking on nonsurgical interventions, as well as on outcomes other than breastfeeding.

6. LEVEL 1: REVIEW Treatment of Ankyloglossia for Reasons Other Than Breastfeeding: A Systematic Review, S Chinnadurai et al, Pediatrics, Volume 135, number 6, June 2015

ABSTRACT Background and Objective: Children with ankyloglossia, an abnormally short, thickened, or tight lingual frenulum, may have restricted tongue mobility and sequelae, such as speech and feeding difficulties and social concerns. We systematically reviewed literature on feeding, speech, and social outcomes of treatments for infants and children with ankyloglossia. Methods: Medline, PsycINFO, Cumulative Index of Nursing and Allied Health Literature, and Embase were searched. Two reviewers independently assessed studies against predetermined inclusion/exclusion criteria. Two investigators independently extracted data on study populations, interventions, and outcomes and assessed study quality. Results: Two randomized controlled trials, 2 cohort studies, and 11 case series assessed the effects of frenotomy on feeding, speech, and social outcomes. Bottle feeding and social concerns, such as ability to use the tongue to eat ice cream and clean the mouth, improved more in treatment groups in comparative studies. Supplementary bottle feedings decreased over time in case series. Two cohort

GM Tongue Tie Policy v2.0 FINAL Page 15 of 23 studies reported improvement in articulation and intelligibility with treatment. Other benefits were unclear. One randomized controlled trial reported improved articulation after Z-frenuloplasty compared with horizontal-to-vertical frenuloplasty. Numerous noncomparative studies reported speech benefits posttreatment; however, studies primarily discussed modalities, with outcomes including safety or feasibility, rather than speech. We included English-language studies, and few studies addressed longer term speech, social, or feeding outcomes; nonsurgical approaches, such as complementary and alternative medicine; and outcomes beyond infancy, when speech or social concerns may arise. Conclusions: Data are currently insufficient for assessing the effects of frenotomy on non-breast feeding outcomes that may be associated with ankyloglossia.

7. LEVEL 3: COHORT STUDY Tongue-tie division. Is it worth it? A retrospective cohort study, S Braccio et al, British Journal of Midwifery, 2016, vol./is. 24/5(317-321), 09694900

Abstract Background: Breastfeeding is a complex process, influenced by various factors. Tongue tie may be an impediment to breastfeeding, so division of tongue tie (frenotomy) is routinely recommended to improve breastfeeding. Aims: This study aimed to assess the value of frenotomy based on its impact on breastfeeding-related problems. Methods: A 1-year retrospective cohort study was undertaken of all the patients referred to a London - based tongue-tie service with breastfeeding difficulties. A telephone survey was performed using a standardised questionnaire. Findings: The rate of exclusively breastfed babies increased from 36.7% before frenotomy to 53.8% at 48 hours post-procedure. All the breastfeeding-related problems significantly reduced by 48 hours post- procedure. There was no major bleeding, infection or ulceration reported. Of babies that had frenotomy, 3.2% underwent a second procedure. Conclusions: Frenotomy is a well-tolerated surgical procedure accompanied by very low complication rates. It significantly increases the exclusive breastfeeding rate in the short-term period and reduces breastfeeding-related problems.

8. LEVEL N/A: PROFESSIONAL GUIDANCE Tongue-tied, RCM website (Extract from advice page)

Problems that can lead to referral for tongue -tie division: Mother  Painful nipples  Recurrent or breast abscesses  Diminished milk supply  Exhaustion from frequent feeding  Psychological effects. Baby  Difficulty in breast attachment  Fussing during feeds  Prolonged or frequent feedings  Prolonged jaundice  Excessive weight loss. In bottle-fed infants  Difficulty taking a teat  Prolonged feeds  Excessive dribbling or wind.

GM Tongue Tie Policy v2.0 FINAL Page 16 of 23

Scientific Advisory Committee on Nutrition (SACN): Update on folic acid (Published: 12 July 2017)

4) Current recommendations on folate intake Reference nutrient intakes for folate 34. The reference nutrient intake (RNI) is the amount of a nutrient that is considered sufficient to meet the requirements of 97.5% of the population. For adults, the RNI for folate is 200 μg/d. For infants and children, the RNIs per day are: 0-12 months, 50 μg; 1-3y, 70 μg; 4-6y, 100 μg; 7-10y, 150 μg; for children 11y and above, the RNI is the same as that for adults. Recommended upper intake levels for folic acid 35. Although folates occur naturally in a wide range of foods, they are present in relatively low amounts. This means that it is hard to achieve high folate intakes from consumption of naturally occurring folates alone. In addition, the absorption of naturally occurring folates is approximately 50% lower than that of folic acid. Concerns regarding the safety of high intakes are therefore restricted to folic acid. 36. In the USA and Europe, a Tolerable Upper Intake Level (UL) of 1 mg/d of folic acid was set for adults (Food and Nutrition Board, 1998; Scientific Committee on Food, 2000). The UL represents the highest level of a nutrient that is likely to pose no risk of adverse health effects to almost all individuals in the general population. It applies to long-term exposure on a daily basis. The UL was based on the risk of progression of neurological symptoms in vitamin B12 deficient patients. ULs for children in the USA11 and Europe12 were extrapolated from the UL for adults on the basis of relative body weight. 37. In the UK, safe levels of intake for vitamins and minerals in food supplements and fortified foods were set by the Expert Group on Vitamins and Minerals (2003). Safe Upper Levels (SULs) were set when supported by adequate data. SULs represent intakes that can be consumed over a lifetime without significant risk to health. A Guidance Level (GL) was set when there were insufficient data to determine an SUL. GLs represent an approximate indication of intakes that would not be expected to cause adverse effects. An SUL was not set for folic acid intake as the available evidence on adverse effects of folic acid was not considered to be sufficiently robust but a GL of 1 mg/d was set based on concerns that intakes above this level may mask signs of vitamin B12 deficiency. GLs were not set for children as there were no data reporting adverse effects in children. 7) Overall summary and conclusions Background 133. Conclusive evidence from RCTs has shown that folic acid supplementation during the early stages of pregnancy can reduce the risk of the fetus developing NTDs. All women planning a pregnancy are therefore advised to take a daily supplement of folic acid (400 μg) prior to conception and until the 12th week of pregnancy. Women with a previous pregnancy affected by NTDs or women with spina bifida themselves are advised to take folic acid supplements of 5 mg/d19. 134. Evidence indicates that this advice has not been followed. It has been estimated that the proportion of women who reported taking folic acid supplements prior to pregnancy has declined from 35% in 1999-2001 to 31% in 2011-12y. Another limitation to the value of recommending folic acid supplementation prior to conception is that only about half of all pregnancies in Britain are planned. Importantly, significant reductions in NTD prevalence have been reported in countries where mandatory folic acid fortification has been introduced. For example, in the USA, where mandatory fortification was introduced in 1998, there was a corresponding 28% reduction in prevalence of anencephaly and spina bifida post-fortification (1999-2011). 135. In 2006, SACN recommended mandatory fortification of flour with folic acid to improve the folate status of women most at risk of NTD-affected pregnancies in the UK (SACN, 2006). It stipulated, however, that it should only be introduced alongside restrictions on voluntary fortification of foods with folic acid. This was to ensure no increase in the numbers of people with intakes above the GL/UL and no substantial increase in mean folic acid intakes or folate status of the UK population.

GM Tongue Tie Policy v2.0 FINAL Page 17 of 23 136. In 2007, following publication of two studies suggesting potential adverse effects of folic acid on colorectal cancer risk, SACN was requested by the Chief Medical Officer to conduct a detailed review of these data. In 2009, the Committee concluded that there were uncertainties regarding folic acid and cancer risk but reiterated its previous recommendation for mandatory folic acid fortification together with controls on voluntary fortification, guidance on supplement use and appropriate population monitoring procedures. In addition, people aged over 50y and those with a previous history of colorectal adenomas were advised not to consume supplements containing folic acid above the RNI for folate (200 μg/d). 137. In February 2016, FSS informed SACN that in the absence of progress regarding mandatory folic acid fortification in the UK, Scottish Ministers were considering whether to proceed unilaterally with mandatory folic acid fortification of flour in Scotland. FSS requested advice on whether SACN’s 2006 and 2009 recommendations on mandatory folic acid fortification remained applicable. In response, SACN agreed to conduct a review of evidence published since its previous risk assessments.

Added after September 2020 review:

9. LEVEL 3: PROSPECTIVE COHORT STUDY

Epidemiology: Sleep Breath. 2017 Sep;21(3):767-775. doi: 10.1007/s11325-016-1452-7. Epub 2017 Jan 17. Toward a functional definition of ankyloglossia: validating current grading scales for lingual frenulum length and tongue mobility in 1052 subjects - Audrey Yoon1 & Soroush Zaghi2,3 & RachelWeitzman4 & Sandy Ha5 & Clarice S. Law1 &Christian Guilleminault6 & Stanley Y.C. Liu2

Abstract Purpose Alterations of the lingual frenulum may contribute to oromyofacial dysfunction, speech and swallowing impediments, underdevelopment of the maxillofacial skeleton, and even predispose to sleep breathing disorder. This study aims to assess the utility of existing instruments for evaluation of restricted tongue mobility, describe normal and abnormal ranges of tongue mobility, and provide evidence in support of a reliable and efficient measure of tongue mobility. Methods A prospective cohort study of 1052 consecutive patients was evaluated during a 3 -month period. Age, gender, ethnicity, height, weight, BMI, maximal interincisal mouth opening (MIO), mouth opening with tongue tip to maxillary incisive papillae at roof of mouth (MOTTIP), Kotlow’s free tongue measurement, and presence of severe tongue-tie were recorded. Secondary outcome measures include tongue range of motion deficit (TRMD, difference between MIO and MOTTIP) and tongue range of motion ratio (TRMR, ratio of MOTTIP to MIO). Results Results indicate that MIO is dependent on age and height; MOTTIP and TRMD are dependent on MIO; Kotlow’s free-tongue measurement is an independent measure of free-tongue length and tongue mobility. TRMR is the only independent measurement of tongue mobility that is directly associated with restrictions in tongue function. Conclusions We propose the use of tongue range of motion ratio as an initial screening tool to assess for restrictions in tongue mobility. Functional ankyloglossia can thus be defined and treatment effects followed objectively by using the proposed grading scale: grade 1: tongue range of motion ratio is >80%, grade 2: 50–80%, grade 3: < 50%, grade 4: < 25%.

GM Tongue Tie Policy v2.0 FINAL Page 18 of 23 Appendix 2 – Clinical Coding – ICD10/OPCS4 Surgical management of Ankyloglossia (tongue tie) GM050

(All codes have been verified by Mersey Internal Audit’s Clinical Coding Academy)

GM050 – Surgical management of Ankyloglossia (tongue tie)

OPCS-4 Procedure Codes:

Excision of frenulum of tongue F262

Incision of frenulum of tongue F263

Other specified other operations on tongue (might be used for frenuloplasty) F268

Unspecified other operations on tongue (might be used for frenuloplasty) F269

With the following ICD-10 diagnosis codes:

Ankyloglossia Q381

GM Tongue Tie Policy v2.0 FINAL Page 19 of 23 Appendix 3 – Hazelbaker Assessment Tool for Lingual Frenulum Function Surgical management of Ankyloglossia (tongue tie) GM050

Name: DOB: NHS No: Hospital No:

Appearance Items Function Items Appearance of tongue when lifted: Lateralization:  2: Round or square  2: Complete  1: Slight cleft in tip apparent  1: Body of tongue but no tongue tip  0: Heart- or V-shaped  0: None Elasticity of frenulum: Lift of tongue:  2: Very elastic  2: Tip to mid-mouth  1: Moderately elastic  1: Only edges to mid-mouth  0: Little or no elasticity  0: tip stays at lower alveolar ridge or rises to mid- mouth only with jaw closure Length of lingual frenulum when tongue lifted: Extension of tongue:  2: > 1 cm  2: tip over lower lip  1: 1 cm  1: Tip over lower gum only  0: < 1 cm  0: Neither of the above, or anterior or mid-tongue humps Attachment of lingual frenulum to tongue: Spread of anterior tongue:  2: Posterior to tip  2: Complete  1: At tip  1: Moderate or partial  0: Notched tip  0: Little or none Attachment of lingual frenulum to inferior Cupping: alveolar ridge:  2: Attached to the floor or well below ridge  2: Entire edge, firm cup  1: attached just below ridge  1: Side edges only, moderate cup  0: attached at ridge  0: poor or no cup Peristalsis: Total Appearance Score = ______ 2: Complete, anterior to posterior

 1: partial, originating posterior to tip Total Functional Score = ______ 0: None or reverse motion Significant ankyloglossia diagnosed when appearance score total is 8 or less and/or function score total is 11 or Snapback: less. 2: None Severe maternal nipple pain during breastfeeding, without  alternate explanation as assessed by a Lactation Consultant, is 1: Periodic also grounds to consider FRENULOTOMY if a tight anterior  frenulum is noted.  0: frequent or with each suck

ASSESSMENT COMPLETED BY (PRINT NAME): SIGNATURE:

DATE OF ASSESSMENT: DESIGNATION:

GM Tongue Tie Policy v2.0 FINAL Page 20 of 23 Appearance of the tongue when lifted is determined by inspecting the anterior edge of the tongue as the infant cries or tries to lift or extend the tongue. The elasticity of the frenulum is determined by palpating the frenulum for elasticity while lifting the infant’s tongue. The length of the lingual frenulum is determined by noting its approximate length in centimetres as the tongue is lifted. Attachment of the frenulum to the tongue is determined by noting its origin on the inferior aspect of the tongue. It should be approximately 1 cm posterior to the tip. The attachment of the lingual frenulum to the inferior alveolar ridge is determined by noting the location of the anterior attachment of the frenulum. It should insert proximal to or into the genioglossus muscle on the floor of the mouth. Lateralization is measured by eliciting the transverse tongue reflex by tracing the lower gum ridge and brushing the lateral edge of the tongue with the examiner’s finger. Lift of the tongue is noted when the finger is removed from the infant’s mouth. If the infant cries, then the tongue tip should lift to mid-mouth without jaw closure. Extension of the tongue is measured by eliciting the tongue extrusion reflex by brushing the lower lip downward toward the chin. Spread of anterior tongue is determined by first eliciting a rooting reflex, just before cupping, by tickling the upper and lower and looking for even thinning of the anterior tongue. Cupping is a measure of the degree to which the tongue hugs the finger as the infant sucks on it. Peristalsis is a backward, wave-like motion of the tongue during sucking that should originate at the tip of the tongue and is felt with the back of the examiner’s finger. Snapback is heard as a clucking sound when the tethered tongue loses it grasp on the finger or breast when the infant tries to generate negative pressure.

Ballard, J.L., Auer, C.E., Khoury, J.C. (2002). Ankyloglossia: Assessment, Incidence, and Effect of Frenuloplasty on the Brea stfeeding Dyad. Pediatrics 2002;110;e63

Ankyloglossia Grading: Class I: mild ankyloglossia, 12-16 mm Class II: moderate ankyloglossia, 8-11mm Class III: severe ankyloglossia, 3-7 mm Class IV: complete ankyloglossia, less than 3 mm

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Appendix 4 – Version History Surgical management of Ankyloglossia (tongue tie) GM050

The latest version of this policy can be found here GM Tongue Tie Policy

Version Date Summary of Changes

0.1 24/04/2018 Initial draft

0.2 16/05/2018 The GM EUR Steering Group requested the following amendments: Commissioning Statement  Frenuloplasty paragraph reworded and moved to ‘Policy Exclusions’ section  ‘at the time of referral’ added to end of ‘The infant is under 3 months of age’  ‘Frenectomy’ added to start of heading for ‘For infants with feeding problems’ and first bullet point reworded  Heading added for 'Frenectomy for older children with speech problems' and paragraph rewritten  Recommended GMEURSG funding mechanisms added for infants (MA) and Frenectomy for older children with speech problems (Exceptionality) Following the above changes the group agreed the policy could go out for a period of clinical engagement.

0.3 19/09/2018 GM EUR Steering Group reviewed the feedback received during the period of Clinical Engagement and agreed the following amendments:  Policy Exclusions: ‘This policy applies to children before their 18th Birthday’ added.  Policy Inclusion Criteria: o The first bullet point ‘An assessment of the degree of ankyloglossia has been carried out using the Hazelbaker Assessment Tool (see Appendix 3) which gives a score of less than or equal to 11’ removed.  The ‘NOTE’ in this section reworded from ‘The procedure should be performed as an outpatient procedure or suitable community service.’ to ‘Frenectomy to address the above should be performed as an outpatient procedure or within a suitable community service.’  Subheading and two bullet points added for ‘Onward referral to Tier 2 or Secondary care’.  Glossary: Definition of ‘Frenulotomy’ added. GM EUR Steering Group agreed that following the above amendments the policy could progress through the governance process.

0.4 01/10/2018 Branding changed to reflect change of service from Greater Manchester Shared Services to Greater Manchester Health and Care Commissioning.

0.5 26/11/2018 Diagnostic and Procedure Codes added to Appendix 2.

0.6 01/08/2019 Clinical Exceptionality Section updated to read: Clinicians can submit an Individual Funding Request (IFR) outside of this guidance if they feel there is a good case for exceptionality. More information on determining clinical exceptionality can be found in the Greater Manchester (GM) Effective Use of Resources (EUR) Operational Policy. Link to GM EUR Operational Policy

1.0 29/08/2019 Policy approved for implementation by the Greater Manchester Directors of Commissioning / Greater Manchester Chief Finance Officers.

GM Tongue Tie Policy v2.0 FINAL Page 22 of 23 1.1 13/09/2019 Policy approved for implementation by Bolton CCG

1.2 20/05/2020 Equality and Equity Statement – GM EUR Policy Team email address updated

2.0 16/09/2020 The GM EUR Steering Group reviewed the policy and agreed to the following amendments: Policy Inclusion Criteria:  Under Frenectomy for infants with feeding problems, added: ‘If a bottle fed infant has feeding issues related to tongue tie, then an IFR application should be made – if the infant is failing to thrive, this must be marked URGENT’  Under Frenectomy for older children with speech problems, the second bullet point amended to read: ‘A score of the degree of tongue tie using the Kotlow Classification of tongue tie (ankyloglossia) rather than Hazelbaker Assessment Tool. A diagram of this was also added below the bullet point and a statement added: ‘If the referral is from a specialist service, the tongue range of motion ratio can be given instead.

Appendix 1 – Evidence Review - added: An abstract from ‘Epidemiology: Sleep Breath. 2017 Sep;21(3):767-775. doi: 10.1007/s11325-016-1452-7. Epub 2017 Jan 17. Toward a functional definition of ankyloglossia: validating current grading scales for lingual frenulum length and tongue mobility in 1052.

Date of Review: The policy will be reviewed again in 5 years, unless new evidence or technology is available sooner.

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