Conventional vs Digital CAD/CAM Splints for Bruxism
NCT Number: NCT06518447
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bruxism
Interventions: DEVICE: Digital occlusal splints (CAD/CAM)|DEVICE: Conventional occlusal splints
Sponsor: Pontificia Universidade Católica do Rio Grande do Sul
Sex: ALL
Age: ADULT
Enrollment: 20
Study Design: Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: DOUBLE (PARTICIPANT, INVESTIGATOR)|Primary Purpose: TREATMENT
Start Date: 2024-08-01
Completion Date: 2025-01-31
Locations: Faculdade de Odontologia. Pontifícia Universidade Católica do Rio Grande do Sul., Porto Alegre, RS, 90619-900, Brazil

Summary:
This is a randomized controlled trial with a crossover design, which intends to enroll 20 adult patients aged between 20 and 55 years with confirmed or probable sleep bruxism. Participants will be randomized to receive either a conventional stabilization splint or a CAD/CAM splint. Each patient will use one type of splint for 30 days, followed by a 15-day wash-out period, after which they will switch to the other type of splint. The study aims to compare the quality, precision, and comfort of the two types of occlusal splints. Outcomes will include manufacturing time, amount of in-mouth adjustments, adaptation, occlusal contacts, and participant satisfaction.

Primary Outcome Measures: Number of occlusal contacts, The number of occlusal contacts will be measured using the OccluSense® device, Immediately after the initial installation
Secondary Outcome Measures: Time Required for Splint Adjustment, The time required to adjust each splint during the fitting process, Immediately after the initial installation and adjustment|Participant satisfaction after installation, Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction., Immediately after the initial installation and adjustment|Participant satisfaction after 30 days, Patients will assess their overall satisfaction with the splints using a 5-point Likert scale, with 1 meaning the lowest score of satisfaction and 5 meaning the highest score of satisfaction., After 30 days of use|Splint comfort after installation, Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort., Immediately after the initial installation and adjustment|Splint comfort after 30 days, Patients will assess comfort with the splints using a 5-point Likert scale, with 1 indicating the lowest level of comfort and 5 indicating the highest level of comfort., After 30 days of use|Splint stability after installation, Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement)., Immediately after the initial installation and adjustment|Splint stability after 30 days, Patients will assess the stability of the splints (retention) during use using a 5-point Likert scale, with 1 indicating the lowest level of stability (frequent movement) and 5 indicating the highest level of stability (no movement)., After 30 days of use