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

Abstract

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 http://ClinicalTrials.gov, Identifier number NCT02340663.

Managements of sleep bruxism in adult: A systematic review

“…Four articles applied a mandibular anterior repositioning splint, and the other two applied the anterior splint. Combining the results of four studies that used the only palatal coverage splint as a control, the stabilization appliance showed a higher tendency to reduce the SB number during the short-term period; however, there was no difference after 2–6 weeks follow-up [31] , [32] , [33] , [34] , [35] . The total sample size of intervention/control was 89/89 subjects, and intervention periods were 3 days to 4 months.…”

Sleep related movement disorders in the elderly: a review of recent literature

“…Though in a study of patients with an average age of 25.5 years, more affordable, over-the-counter (OTC) fabricated splints have demonstrated less efficacy in reducing RMMA bursts compared to those devices created by dental professionals (Abe et al, 2023). Massage therapy and Kinesio tape may also play a role in treating SB (Keskinruzgar et al, 2019;Gerstner et al, 2020). Biofeedback splints that can provide sensory feedback in response to nocturnal masticatory clenching is another area that is under investigation for the treatment of SB, but concerns regarding the potential disruptive effects on sleep are an important consideration (Ilovar et al, 2014;Volkan-Yazici et al, 2021).…”

Efficiency of mixed and rigid occlusal stabilization splints: Randomized clinical trial

“…14 Soft splints are also popular; however, there is no evidence of their efficacy and effectiveness, 15 and they seem to stimulate muscle contractions, 12 which can aggravate bruxism. 10,16 The mixed splint, 10 consisting of an acetate sheet and a self-curing acrylic cover, is built only by dental surgeons, which requires longer chair time. This can lead to a higher cost, considering the care in private practice.…”

“…17 In Brazil, the public health service provides specialized care in the areas of endodontics, periodontics, dentistry, surgery, and prosthetics. 16 Occlusal splints for the control of SB, despite the great demand, are not included in public policies, possibly because of their high cost. 14 Thus, the present study aimed to evaluate the efficacy of a low-cost, mixed occlusal splint (MOS) compared to that of a rigid splint in patients with SB, considering its durability and effect on masticatory muscle and TMJ pain, quality of life (QoL), indentations in the oral mucosa, anxiety, and depression.…”