Occlusal Splints in the Treatment of Sleep Bruxism (bruxism)

June 20, 2022 updated by: Dr. Merve Benli, Istanbul University

The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism

Occlusal splints are employed in the treatment of sleep bruxism. These appliances decrease sleep-related actions and damages bruxism, like grinding, tooth-wear, headache, and temporomandibular joint disorders. Occlusal splints are produced both in hard and soft forms according to the used material.

In this study, it was aimed to evaluate the effect of occlusal splint type on the sleep quality and occlusal force parameters of patients with sleep bruxism.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Various splint designs have been used for the treatment of sleep bruxism that is made up of different materials: Hard and soft splints. Although, these splints have slightly different appearances and properties, in fact, scientific evidence supports both the use of hard and soft occlusal splints. Hard splints are more preferred when compared to soft ones, thus, oft appliances have been less documented in the scientific literature. However, some studies suggested the use of soft-resin splints that are easily fabricated and may be inserted at an initial appointment, dental clinicians may desire the use of soft appliances. One of the advantages of these appliances is they are easy to tolerable to the patient and comfortable. Additionally, these splints fit tightly and provide a flat plane during sleep.

Considering these advantages, the present study was designed to examine the effect of the use of different types of occlusal splints on the sleep quality and occlusal force of patients with sleep bruxism. For this purpose, the effect of two splints basically fabricated from two different materials were evaluated and compared. The null hypothesis was that the use of both occlusal splints would not change the values of sleep quality and maximum occlusal force of the patients with sleep bruxism.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
      • Fatih, Turkey, 34452
        • Istanbul university,Faculty of Dentistry

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

- Healthy participants with complete permanent dentition.

Exclusion Criteria:

  • Presence of a systemic disorder that could compromise the masticatory system (e.g., neurological disorders, epilepsy, cerebral palsy, among others),
  • Systemic disorder or current use of drugs that could interfere, directly or indirectly, with muscle activity,
  • Inappropriate behavior and/or refusal to cooperate with dental procedures and data collection,
  • Tooth loss (except for third molars),
  • Soft tissue abnormalities,
  • Toothache report,
  • Active periodontitis (presence of periodontal pockets involvement of the supporting tissues),
  • Caries lesions,
  • Use of orthodontic appliances,
  • Use of dental prosthesis (fixed or removable partial).
  • Subjects with moderate to severe malocclusions, diagnosed by using the Orthodontic Treatment Need Index (IOTN) (scores 5 or 6 - severe and extreme need for orthodontic treatment)
  • Alcohol or drug abuse,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Hard splint group- 2 mm thicknesss
This group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep
Device: Occlusal splint
Using occlusal splints during sleep for 2 months
Experimental: Hard splint group- 3 mm thicknesss
This group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep
Device: Occlusal splint
Using occlusal splints during sleep for 2 months
Experimental: Soft splint group- 2 mm thicknesss
This group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep
Device: Occlusal splint
Using occlusal splints during sleep for 2 months
Experimental: Soft splint group- 3 mm thicknesss
This group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep
Device: Occlusal splint
Using occlusal splints during sleep for 2 months

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sleep quality
Time Frame: 2 months
Evaluating sleep quality with Pittsburgh sleep quality index
2 months
occlusal force
Time Frame: 2 months
Measuring maximum occlusal force by using digital gnatodynanometer
2 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 6, 2021

Primary Completion (Actual)

December 12, 2021

Study Completion (Actual)

December 14, 2021

Study Registration Dates

First Submitted

June 16, 2021

First Submitted That Met QC Criteria

June 16, 2021

First Posted (Actual)

June 22, 2021

Study Record Updates

Last Update Posted (Actual)

June 22, 2022

Last Update Submitted That Met QC Criteria

June 20, 2022

Last Verified

June 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1299 (OHSU eIRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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