MedTrace Logo

In Vivo Comparison of Two Different Occlusal Splints in Bruxism

NCT06482060 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-07-01

No results posted yet for this study

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.

Conditions

  • Bruxism

Interventions

DEVICE

Stabilization splint

Stabilization splint application is a treatment that improves the function of TMJ and masticatory muscles by creating a balanced, stable occlusion to reduce the effects of occlusal interference and parafunctional habits and eliminate associated pain.

Sponsors & Collaborators

  • Marmara University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-05-01
Primary Completion
2024-03-01
Completion
2024-05-01

Countries

  • Turkey (Türkiye)

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06482060 on ClinicalTrials.gov