Clinical Practice Guidelines for Oral Management of Sjogren Disease
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PRACTICE GUIDELINES Clinical practice guidelines for oral management of Sjögren disease Dental caries prevention Domenick T. Zero, DDS, MS; Michael T. Brennan, DDS, MHS; ABSTRACT Troy E. Daniels, DDS, MS; Athena Papas, DMD, PhD; Carol Stewart, DDS, MS; Andres Pinto, DMD, MPH, MSCE; Background. Salivary dysfunction in Sjögren disease can Ibtisam Al-Hashimi, BDS, MS, PhD; Mahvash Navazesh, lead to serious and costly oral health complications. Clin- DMD; Nelson Rhodus, DMD, MPH; James Sciubba, DMD, ical practice guidelines for caries prevention in Sjögren PhD; Mabi Singh, DMD, MS; Ava J. Wu, DDS; disease were developed to improve quality and consistency Julie Frantsve-Hawley, RDH, PhD; Sharon Tracy, PhD; of care. Philip C. Fox, DDS; Theresa Lawrence Ford, MD; Methods. A national panel of experts devised clinical Stephen Cohen, OD; Frederick B. Vivino, MD, MS; questions in a Population, Intervention, Comparison, Katherine M. Hammitt, MA; for the Sjögren’s Syndrome Outcomes format and included use of fluoride, salivary Foundation Clinical Practice Guidelines Committee stimulants, antimicrobial agents, and nonfluoride remi- neralizing agents. The panel conducted a systematic search of the literature according to pre-established parameters. alivary dysfunction can have serious adverse At least 2 members extracted the data, and the panel rated effects on the oral health of patients with Sjögren the strength of the recommendations by using a variation disease (formerly known as Sjögren syndrome), of grading of recommendations, assessment, development, making it paramount that the oral clinician uses and evaluation. After a Delphi consensus panel was con- S ducted, the experts finalized the recommendations, with a every means possible to prevent complications. Patients with Sjögren disease have significantly higher levels of minimum of 75% agreement required. dental caries, require more tooth extractions, and report Results. Final recommendations for patients with higher dental expenses over their lifetime than do con- Sjögren disease with dry mouth were as follows: topical 1 fluoride should be used in all patients (strong); although no trols. Sjögren disease fl clearly is associated study results link improved salivary ow to caries preven- with a high burden tion, the oral health community generally accepts that of disease, including increasing saliva may contribute to decreased caries inci- 2 5 diminished quality of life - and increased health care dence, so increasing saliva through gustatory, masticatory, 5 7 5 costs, - especially high dental care costs. or pharmaceutical stimulation may be considered (weak); chlorhexidine administered as varnish, gel, or rinse may be Sjögren disease is the second most common auto- fl immune connective tissue disease, affecting up to 3.1 considered (weak); and non uoride remineralizing agents million Americans according to the National Arthritis may be considered as an adjunct therapy (moderate). 8 Data Workgroup, or approximately 1 in 70 people. This Conclusions and Practical Implications. The inci- dence of caries in patients with Sjögren disease can be number represents those with Sjögren disease alone fl (traditionally referred to as primary Sjögren disease); the reduced with the use of topical uoride and other pre- number affected approximately doubles if those with ventive strategies. Key Words. Sjögren syndrome; xerostomia; practice another major autoimmune or rheumatic disease in fl fl addition to Sjögren disease are included. Although guidelines; uoride; antimicrobial; salivary ow; remineralization. JADA 2016:-(-):--- http://dx.doi.org/10.1016/j.adaj.2015.11.008 Copyright ª 2016 American Dental Association. All rights reserved. JADA -(-) http://jada.ada.org - 2016 1 PRACTICE GUIDELINES Sjögren disease is a systemic disease and can affect any of this article). At least 2 TRG members extracted the body organ or system, dry mouth and dry eyes are chief data, and the TRG as a whole rated the strength of the 4 9 symptoms. , Sjögren disease causes chronic inflam- evidence, developed a draft recommendation, and rated mation and dysfunction and, ultimately, damages the the strength of the recommendation. We based grading salivary glands. of the evidence and strength of the recommendation The Sjögren’s Syndrome Foundation (SSF) set about largely on grading of recommendations, assessment, 15 establishing the first-ever clinical practice guidelines for development, and evaluation, which rates the quality Sjögren disease to improve consistency and quality of of the evidence on the basis of study limitations, care for assessing and managing the disease. It is critical inconsistency of results, indirectness of evidence, for oral health care professionals to identify patients imprecision, and publication bias (very low quality potentially having Sjögren disease and ensure that they to high quality). We rated the strength of the recom- obtain a correct diagnosis and start appropriate man- mendation on the basis of quality of evidence, balance agement to prevent caries. Care must be coordinated by a of benefits and harms, values and preferences, and costs team of health care professionals that includes a dentist, (strong or weak both for and against). For the strength rheumatologist, and ocular specialist. The SSF clinical of the recommendation, we used a variation of grading practice guidelines for caries prevention address clinical of recommendations, assessment, development, and questions pertaining to the use of fluoride, salivary evaluation that was developed by the American Society 16 stimulants, antimicrobial agents, and nonfluoride remi- of Clinical Oncology. (Appendix 4 provides defini- neralizing agents. tions used for the strength recommendations, and Appendix 5 provides the guidelines statement regarding METHODS decision on grading the quality of evidence; available The SSF followed a highly transparent and rigorous online at the end of this article). process in developing clinical practice guidelines. We followed a Delphi-type process to ascertain level Guideline protocols and principles were based on those of agreement from practitioners and other stakeholders defined by the American College of Rheumatology, the before finalizing recommendations. The TRGs sum- Institute of Medicine, and the Appraisal of Guidelines marized the data and rationale for the recommenda- for Research and Evaluation and involved participation tions they drafted, and we provided these documents by the American Dental Association (ADA) evidence- (Appendix 6, available online at the end of this article, 10 13 based dentistry staff. - Overarching methodological provides clinical rationales and evidence summaries), principles were transparency, involvement of key stake- the data extraction tables, and a summary outlining holders, and consistency. All participants completed the process to the consensus expert panel (CEP) that American College of Rheumatology conflict of interest reviewed the recommendations. The CEP, made up forms. of key stakeholders (listed in Appendix 7,available Methodological process. We established topic review online at the end of this article), voted on each groups (TRGs) for each caries prevention topic. To recommendation by using a 6-point Likert scale with reduce bias as much as possible, we predefined all the following ratings: completely agree, mostly agree, methodology elements, starting with completion of slightly agree, slightly disagree, mostly disagree, and guidelines protocol worksheets (Appendix 1, available completely disagree. Forty-two to 45 CEP members online at the end of this article) for each TRG that voted and added comments for TRG consideration. delineated clinical questions in the patient population, A minimum of 75% agreement was required and clearly intervention, comparison, outcome format and defined met with 1 round of voting for each topic. However, parameters for literature searches and data extraction for because of comments received on the strength of the all selected articles. The ADA conducted a systematic recommendation on fluoride, a second round of literature search by using predetermined terms and pa- consensuswasheldforthisspecific question, leading rameters. A minimum of 2 TRG members reviewed all to CEP agreement to increase the level for the abstracts and selected articles for further review. See the strength of the recommendation. Participants included Preferred Reporting Items for Systematic Reviews and dentists and dental hygienists from academia and 14 Meta-Analyses flow diagrams, Figures 1 through 4, for community practice, oral medicine experts, clinical literature search details; Appendix 2 (available online at researchers, and patientswithSjögrendisease. the end of this article) provides search terms. An ADA guidelines expert and librarian (S.T.) executed the sys- tematic literature search. We prepared data extraction tables that included ABBREVIATION KEY. ADA: American Dental Association. details on study characteristics, sample and disease CD-CP: Casein derivative and calcium phosphate. information, evidence, and study quality for each CEP: Consensus expert panel. SSF: Sjögren’s Syndrome publication (Appendix 3, available online at the end Foundation. TRG: Topic review group. 2 JADA -(-) http://jada.ada.org - 2016 PRACTICE GUIDELINES Records identified through searching Additional records identified through MEDLINE, PubMed, and Cochrane Library— updated literature search on first search executed March 20, 2013, April 21, 2015 and going back to January 1, 1960 (n