Short-term effect of material type and thickness of occlusal splints on maximum bite force and sleep quality in patients with sleep bruxism: a randomized controlled clinical trial.

OBJECTIVE: To evaluate the short-term effects of hard and soft splints of different thicknesses on maximum bite force (MBF) and sleep quality (SQ) in participants with sleep bruxism (SB). METHODS: One-hundred-fifteen patients were randomly allocated to five groups: Groups H2(Hard splint-2 mm), H3(Hard splint-3 mm), S2(Soft splint-2 mm), S3(Soft splint-3 mm), and C (control). Outcomes were MBF (assessed with a digital gnathodynamometer) and SQ (assessed with the Pittsburgh Sleep Quality Index). Measurements were performed at T0 (before the splints), T1 (1-month follow-up), and T2 (2-months follow-up). Data were analyzed using one-way analysis of variance(ANOVA), Tukey's HSD, and chi-square tests (alpha = 0.05). RESULTS: At T1, the highest MBF values were observed in group H3 (658.01 ± 22.6 N), while the lowest in group S2 (585.45 ± 8.68 N). For T2, the highest values were obtained in H3 group (676.85 ± 21.9 N), and the lowest in group S2 (565.65 ± 10.9 N) (p < 0.05).For SQ, groups S2 and S3 revealed the lowest PSQI values at T1 (9.1; 9.6) and T2 (9; 9.5) (p < 0.001). CONCLUSIONS: The short-term use of both 2 and 3-mm thick soft splints resulted in a decrease in MBF. Improvement in SQ in patients using soft splints was observed in the 1st month and was maintained in the 2nd month. CLINICAL RELEVANCE: This study provides insights on short-term clinical effects as regards to increased sleep quality and regulated maximum bite force as a function of splint material type and the thickness of the splint.