Title: Oral splints for patients with temporomandibular disorders or bruxism: a systematic review and economic evaluation
Funder: Department of Health and Social Care

Abstract: Design: We will undertake a systematic review using Cochrane methodology, and develop a decision model to evaluate the cost-effectiveness of different types of splint therapy. The results will identify and prioritise future research needs. Strategy for Reviewing Literature: A comprehensive search of 4 databases, with no restriction on language, using design filters developed by Cochrane, will be managed by bespoke software. The searches will be screened independently in duplicate by two or more assessors to determine studies for inclusion or exclusion from the systematic review. Cochrane methods will be used throughout the review process, and the risk of bias of individual trials being assessed using the Cochrane RoB tool. Revman software will be used to construct forest plots, and for pooling the outcomes in meta-analysis. The quality of the body of evidence will be assessed by GRADE for the outcomes: pain intensity, headaches, toothwear and adverse events. This will be summarised in a Summary of Findings Table. Target Population: Trial reports of randomised controlled trials conducted on patients who have orofacial symptoms or bruxism, attending dentists in either primary or secondary care. Health Technologies Being Assessed: Firstly to compare the provision of any type of oral splint with no splint. Secondly to compare custom-made (requiring more than one visit to fit) versus prefabricated splints. Measurement of Costs and Outcomes: Core outcomes for orofacial symptoms, temporomandibular disorders and bruxism are not included on the COMET website. The primary outcomes will be: change in orofacial pain intensity, number of headaches, tooth wear depending on the patient’s initial condition. Harms will be any adverse effects due to the wearing of the oral splint. The primary economic outcome will be incremental cost per QALY gained. Secondary economic oucomes will include NHS and patient incurred costs, the expected value of perfect information (EVPI) and the expected value of partial perfect information (EVPPI). Project timetable including recruitment rate: 14 months in total. We do not need to recruit any members of the review team. The protocol will be written and agreed over the first 3 months, with patient input, and the data searches undertaken at 3 months. The data will be extracted and the risk of bias assessments made between 3-10 months. The statistical analysis will be undertaken 10-12 months. Economic modelling will be undertaken alongside the review (1-12 months). The HTA report will be written 12-14 months. Experts in team: Multidisciplinary team of systematic reviewers, statisticians, health economics and clinician. HW, AG, PR are experienced systematic reviewers and methodologists having undertaken many Cochrane and non-Cochrane reviews. They are part of the editorial base of Cochrane Oral Health (COH). HW is a statistician with expertise in meta–analysis. AG is a methodologist with expertise in application of GRADE. DB is a health economist with experience in the development of decision analysis models and the economic evaluation of oral health interventions. CR is a systematic reviewer with experience working on large HTA reviews. SD is lead clinician in TMD clinic and member of UK Specialist Interest Group in Orofacial Pain and TMDs (USOT). The team will be supported by a Patient Advisory Group.

Lay abstract: Oral splints are removable appliances, often similar to a mouthguard, that can be provided to patients to help ease pain in the mouth, face or jaws. They can also be used to manage conditions such as frequent headaches/migraines, clicking in the jaws, restricted mouth opening or tooth wear caused by grinding of teeth. There is a large variety of oral splints. Oral splints may cover all or some of the teeth. They may be used on the upper or lower jaw. The methods by which they are made vary, as do the materials used in their manufacture. In previous years, oral splints were made in a dental laboratory, requiring a patient to visit their dentist for initial impressions to be taken. These impressions would then be used to custom-make the splint in a laboratory. The patient would then return to the dentist for a further appointment to have the oral splint fitted and, perhaps adjusted. In recent years, a number of prefabricated splints have been developed. These often allow the dentist to fit the splint in a single appointment. Indeed, some splints are available to buy over-the-counter/online, allowing the patient to ‘self-manage’. The proposed research will look at the evidence for two questions: do oral splints work (regardless of what type of splint) in reducing orofacial pain and/or toothwear. The second question is whether there is evidence of a difference in efficacy between the prefabricated and custom-made splints. Part of the research is an economic assessment weighing up, whether dentists should be treating patients with these oral splints, and secondly the balance between the differences in effects and the costs of the two different types of splints. The research will also make recommendations about what future trials are needed to answer any questions not yet answered. To address both questions we will undertake a systematic review of the literature to find all randomised controlled trials including patients with orofacial pain or bruxism. We will search online databases of research publications and will screen these searches to identify relevant trials. All screening and data extraction will be undertaken to the highest standards by two people independently in duplicate, using well respected and recognised Cochrane methods. We have already identified several trials for inclusion in both parts of the systematic review that will enable statistical pooling of data for both questions. The overall quality of the body of evidence will also be assessed by an internationally standard method (GRADE). Patient input will be sought to ensure the research focuses on issues important to them.

Research activity codes: 6.3 MEDICAL DEVICES
Health categories: ORAL AND GASTROINTESTINAL