Clinical Trial Protocol Iranian Registry of Clinical Trials

02 Oct 2021

Effects of one-stage full mouth disinfection versus periodontal surgery on oral health-related quality of life in patients with chronic periodontitis

Protocol summary Registration date 2017-10-02, 1396/07/10 Summary Background: Patient-based outcome is an important Registrant information aspect of periodontal treatments. Information on Name patients' quality of life after periodontal treatment is Golpar Radafshar limited. Aim: This is a quasi-experimental interventional Name of organization / entity Guilan University of Medical Sciences, School of study aiming at determining the patient perception of dentistry oral health and the impact that non-surgical and surgical Country periodontal therapy have on their quality of life. 40 Iran (Islamic Republic of) patients with moderate to advanced chronic periodontitis Phone will be recruited to participate in this study. Subjects are +98 13 1323 0775 from those who visit a private clinic for the diagnosis and Email address treatment of periodontitis. All the patients sign an [email protected] informed consent upon entry. At baseline and after non- surgical and surgical treatment, periodontal parameters Recruitment status comprised of pocket depth, clinical attachment level, and Recruitment complete bleeding on probing will be recorded by a blind Funding source examiner. Periodontal non-surgical treatment is This is a self-funding research. comprised of one-stage full mouth disinfection (Quirynen 1995). Surgical treatment involves quadrant-based open Expected recruitment start date flap debridement with minor osseous surgery. Patients 2017-10-15, 1396/07/23 will complete the Iranian version of the Oral Health Expected recruitment end date Impact Profile (OHIP) questionnaire (OHIP-35 after 2018-08-15, 1397/05/24 validation), at three stages: baseline, one week post- Actual recruitment start date initial therapy, and after completion of periodontal empty surgical phase. Data will be analyzed using repeated Actual recruitment end date measure ANOVA, paired and independent t-tests, and empty Green house-Geisser by SPSS software version 21. Trial completion date empty General information Scientific title Acronym Effects of one-stage full mouth disinfection versus IRCT registration information periodontal surgery on oral health-related quality of life IRCT registration number: IRCT201709211081N8 in patients with chronic periodontitis Registration date: 2017-10-02, 1396/07/10 Registration timing: prospective Public title How periodontal treatment affects oral health-related quality of life in patients with chronic periodontitis Last update: Purpose Update count: 0 Treatment

1 Inclusion/Exclusion criteria 1 Inclusion criteria were a diagnosis of generalized Description of health condition studied moderate to severe chronic periodontitis and having at Chronic periodontitis least 20 standing teeth. The exclusion criteria were a ICD-10 code history of periodontal treatment 6 months prior to entry, K05.3 taking any medication known to affect periodontal ICD-10 code description tissues, taking anti-depressant, anti-anxiety, anti- Chronic periodontitis inflammatory, and immunosuppressive medications, uncontrolled diabetes, pregnancy or lactation, smoking, and needing antibiotic prophylaxis. Primary outcomes Age From 18 years old to 60 years old 1 Gender Both Description Oral health-related quality of life Phase Timepoint 2-3 Baseline, after non-surgical, after surgical intervention Groups that have been masked Method of measurement No information Validated Iranian version of the Oral health impact profile Sample size questionnaire Target sample size: 40 Randomization (investigator's opinion) Secondary outcomes N/A Randomization description Blinding (investigator's opinion) 1 Double blinded Description Blinding description Periodontal pocket depth Placebo Timepoint Not used Baseline, after non-surgical, after surgical interventions Assignment Method of measurement Single Using a periodontal probe, distance from gingival margin Other design features to the base of the pocket is measured The original OHIP-49 questionnaire was validated and standardized for Iranian population using CVI and CVR. 2 Some questions did not meet the appropriate CVI or CVR and were deleted. The resultant questionnaire with 35 Description items was used in this study. Clinical attachment level Timepoint Baseline, after non-surgical, after surgical interventions Secondary Ids Method of measurement empty Using a periodontal probe, distance from a fix point to the base of pocket is measured Ethics committees 3 1 Description Bleeding on probing Ethics committee Timepoint Name of ethics committee Baseline, after non-surgical, after surgical interventions Guilan University of Medical Sciences Method of measurement Street address Lenox & Kopczyk bleeding index School of health old building, opposite 17 Shahrivar hospital, Siadati street, Namjoo road City Intervention groups Rasht Postal code 1 Approval date Description 2016-01-26, 1394/11/06 Non-surgical periodontal treatment based on Quirynen Ethics committee reference number protocol of one stage full mouth disinfection comprised IR.GUMS.REC.1394.395 of scaling and root planing with Chx 0.2% pocket irrigation completed within 24 hours. Health conditions studied Category

2 Treatment - Other Person responsible for general inquiries

2 Contact Name of organization / entity Description Dental Sciences Research Center, Dental Faculty, Surgery comprised of flap debridement with minor Guilan University of Medical Sciences osseous surgery on a quadrant basis over single or Full name of responsible person multiple treatment episodes, according patient’s Nastaran Mirfarhadi treatment needs. In case of multiple sessions, a Position minimum of 2-week interval was considered. MS in nursing education Category Other areas of specialty/work Treatment - Surgery Street address Guilan University of Medical Sciences complex, Recruitment centers Professor Samiee Blv. Gaz square City Rasht 1 Postal code 4194173774 Recruitment center Phone Name of recruitment center +98 13 3326 3616 Dr. Golpar Radafshar's private clinic Fax Full name of responsible person Email Dr. Golpar Radafshar [email protected] Street address Web page address 7th floor, Pasteur Medical Building, Golsar intersection City Rasht Person responsible for scientific inquiries

Sponsors / Funding sources Contact Name of organization / entity 1 Department of Periodontology, Dental Faculty, Guilan University of Medical Sciences Sponsor Full name of responsible person Name of organization / entity Dr. Golpar Radafshar Private clinic, Dr. Golpar Radafshar, associate Position professor of periodontology, Guilan University of Me Associate Professor of periodontology Full name of responsible person Other areas of specialty/work Dr. Golpar Radafshar Street address Street address Guilan University of Medical Sciences complex, 7th floor, Pasteur Medical Building, Golsar Professor Samiee Blv. Gaz square Intersection City City rasht Rasht Postal code Grant name 4194173774 Grant code / Reference number Phone Is the source of funding the same sponsor +98 13 3326 3616 organization/entity? Fax Yes Email Title of funding source [email protected]/ or/ [email protected] Private clinic, Dr. Golpar Radafshar, associate professor Web page address of periodontology, Guilan University of Me Proportion provided by this source Person responsible for updating data 100 Public or private sector Contact empty Name of organization / entity Domestic or foreign origin Department of Periodontology, Dental Faculty, Guilan empty University of Medical Sciences Category of foreign source of funding Full name of responsible person empty Dr. Golpar Radafshar Country of origin Position Type of organization providing the funding Associate professor of periodontoloty empty Other areas of specialty/work

3 Street address Deidentified Individual Participant Data Set (IPD) Guilan University of Medical Sciences complex, empty Professor Samiee Blv. Gaz square Study Protocol City empty Rasht Statistical Analysis Plan Postal code 4194173774 empty Phone Informed Consent Form +98 13 3326 3616 empty Fax Clinical Study Report Email empty [email protected] /or/ [email protected] Analytic Code Web page address empty Data Dictionary Sharing plan empty

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