Effects of Different Occlusal Splints

Effects of Different Occlusal Splints on Joint Vibrations in Bruxers

This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.

Study Overview

• Status: Completed
• Conditions: Bruxism; Bruxism, Sleep; Occlusal Splints
• Intervention / Treatment: Device: occlusal splint

Detailed Description

It was demonstrated that occlusal splints are effectual on improving clinical symptoms and reducing patient complaints in patients with bruxism. However the effects of occlusal splints on joint vibrations are not fully elucidated. The aim of this study is to evaluate the effects of three different occlusal splints (soft, hard and semi-soft) on joint vibrations in patients with bruxism and to compare with asymptomatic individuals. And also clinical symptoms and patient complaints were evaluated with questionnaire forms.

This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.

There was no significant difference in joint vibration parameters between patients with bruxism and asymptomatic individuals before treatment (p>0.0063). Between the increase in soft group and reduction respectively in hard group and semi-soft group for total integral values variations, after treatment at the opening movement for left joint were statistically significant (p=0.005 and p<0.001). Total integral, i>300 Hz, i<300 Hz, Peak amplitude, Peak frequency values of patients with bruxism were observed to be higher than the value of asymptomatic individuals, allthough there was no statistical difference. After three different occlusal splint treatment, it was observed that there was clinically improvement in patient complaints.

• Study Type: Interventional
• Enrollment (Actual): 49
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• The patient has a complaint of grinding/clenching during sleep

• One or more of the following occurs:

  1. abnormal wear of the teeth
  2. sounds associated with the bruxism
  3. jaw muscle discomfort
• No other medical or mental disorders that affecting masticatory muscles activity

Exclusion Criteria:

• Patients with missing at least 2 posterior teeth, except for the third molars
• Presence of Myofascial Pain Dysfunction (MPD)
• Presence of major neurological, psychiatric or motor disorders
• Patients using medications, influencing sleep or motor functions
• Patients with alcohol or drug addiction
• Patients ongoing any dental treatment
• Patients using occlusal splint or exposing the treatment for TMJ disorders in the last 3 months.
• Patients with pregnancy
• Patients with cancer
• Patients with scheduled surgery operation
• Patients with pericoronitis or supraeruption of 3rd molar

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Soft Splint; It is a type of occlusal splint using soft material. It was applied to bruxist patients in accordance with the study design (Group 2).	Device: occlusal splint
Experimental: Hard Splint; It is a type of occlusal splint using hard material. It was applied to bruxist patients in accordance with the study design (Group 3).	Device: occlusal splint
Experimental: Semi-soft Splint; It is a type of occlusal splint using semi-soft material. They cover the advantages of soft and hard occlusal splints. It was applied to bruxist patients in accordance with the study design (Group 4).	Device: occlusal splint

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device	Joint vibration analysis resulting from the movement between temporomandibular joint surfaces was performed by using a Joint Vibration Analysis device (BioPAK (BioResearch, Inc., Milwaukee, WI). Joint vibration analysis parameters were evaluated after occlusal splint treatments in patients with bruxism for each arm.	3 days

Collaborators and Investigators

• Sponsor: Ankara University

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2013
• Primary Completion (Actual): February 15, 2013
• Study Completion (Actual): August 15, 2014

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 18, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 18, 2025
• Last Verified: December 1, 2012

More Information

Terms related to this study

• Keywords: Bruxism; TMJ; Occlusal Splints; Bruxism, Sleep
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Nervous System Diseases; Mental Disorders; Tooth Diseases; Sleep Wake Disorders; Parasomnias; Bruxism; Sleep Bruxism; Anti-Infective Agents; Antifungal Agents; Dermatologic Agents; Keratolytic Agents; Salicylic Acid
• Other Study ID Numbers: 42/4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No