Over‐the‐counter bite splints: A randomized controlled trial of compliance and efficacy

BACKGROUND: Occlusal splints are often used to curb the impacts of sleep bruxism (SB) on the dentition, and over‐the‐counter (OCT) options are becoming increasingly popular. OTC splints are usually fabricated at home by patients, but not routinely evaluated by dental professionals. It is unclear how OCT splints compare with more traditional splints that receive dental oversight. OBJECTIVES: The present randomized controlled study tested how an OTC splint compared with a gold standard bite splint in terms of patient compliance (primary outcome) and efficacy (secondary outcomes). METHODS: Sixty‐seven subjects were randomly assigned to receive either the OTC (SOVA, N = 35) splint or the gold standard “Michigan” bite splint (MI, N = 32), with 61 completing the study (SOVA, N = 30; MI, N = 31). OTC‐splint subjects were required to fabricate their splints to clinically acceptable standards. Both groups wore the splints nightly for four months. Compliance was measured via daily diary. Efficacy outcomes evaluated stability, retention, periodontal health, night‐time rhythmic masticatory muscle activity (RMMA), and material wear. RESULTS: OTC‐splint subjects had difficulty fabricating splints to clinically acceptable standards. The number of night‐time RMMA bursts was significantly greater for the OTC splint group. Compliance and all other efficacy measurements were not significantly different between‐groups. CONCLUSIONS: The results support the potential use of OTC splints for curbing the impacts of SB. However, the results strongly suggest that dentists should be actively engaged in overseeing patients' use of self‐fabricated appliances. This clinical trial is registered at ClinicalTrials.gov, Identifier number NCT02340663.