In Vivo Comparison of Two Different Occlusal Splints in Bruxism
NCT Number: NCT06482060
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Bruxism
Interventions: DEVICE: Stabilization splint
Sponsor: Marmara University
Sex: ALL
Age: ADULT
Enrollment: 30
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2023-05-01
Completion Date: 2024-05-01
Locations: Marmara University School of Dentistry, Istanbul, 34854, Turkey

Summary:
According to the international consensus, bruxism is a masticatory muscle activity consisting of grinding and clenching while sleep or wakefullness. The etiology of bruxism is multifactorial and phisical and psychological facts are some causes of this habit. Bruxism is one of the main causes of tooth wear and temporomandibular joint diseases. Muscle ensembles that occur in bruxist individuals can cause temporomandibular joint degenerations. There is no definitive method recommended for the treatment of sleep bruxism. The most important clinical intervention for sleep bruxism is to protect teeth, reduce teeth grinding, relieve facial and temporal pain and improve sleep quality.

Stabilization splint is the gold standard in temporomandibular joint treatments. The purpose of occlusal splint treatment is to improve the functions of tmj and masticatory muscles by creating a balanced , stable occlusion to eliminate the associated pain to reduce the effects of occlusal interferences and parafunctional habits. Conventional occlusal devices have been fabricated from different materials including polyethylene (PVAc-PE), auto-, heat-, and lightpolymerized acrylic resin. However, despite the interesting characteristics of these materials, they are not considered optimal due to potential thermal discomfort, bad taste, residual monomers, dimensional instability, undesirable shape or color, fracture susceptibility, and skin or respiratory allergies of polymethyl mehacrylate (PMMA) resin, in addition to the time-demanding manufacturing process. New digital technologies based on computer-aided design and computer-aided manufacturing have enabled the use of digital workflow in the fabrication of occlusal devices or other intraoral prostheses such as complete dentures and interim fixed restorations, by using subtractive milling or additive approaches. Such devices are manufactured from prefabricated and standard materials such as polycarbonate, polyetheretherketone (PEEK), and PMMA discs. The whole workflow of digital occlusal splints enhances occlusal design and considerably simplifies and optimizes the traditional occlusal splint manufacturing process. Furthermore, digital occlusal splints have shown superior performance over traditional ones in terms of fit, quantitative control, time-saving, speed, and dimensional stability.

The aim of this study is to evaluate the patient satisfaction and wear rates of occlusal splint materials that fabricated with conventional and CAD/CAM techniques.

Primary Outcome Measures: Change in vertical and volumetric loss of splint material during the treatment, The occlusal surfaces of the stabilization splints were scanned with the 3Shape Trios 3 scanning device (3Shape Dental Systems, Copenhagen, Denmark) three times for each volunteer as before use scan, 3 month end of use scan and 6 months end of use scan. STL images uploaded to Geomagic Control 2014.4.0 program and vertical an volumetric losses are evaluated., At the beginning, 3. months and 6. months
Secondary Outcome Measures: Change in pain of the patient with Visual Analog Scale (VAS) during the treatment, Each month, the volunteers were asked to rate their pain scores according to the visual analog scale (VAS) from 1 to 10., At the beginning, 1. Months and 6. Months|Change in patient satisfaction during the treatment, A Likert-type questionnaire was administered to the volunteers of both groups including the main topics of impression taking session, readjustment of the splint session and ease of use of the splint., At the beginning, 6. Months