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Clinical Trials/NCT04934449
NCT04934449
Completed
Not Applicable

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

Istanbul University1 site in 1 country100 target enrollmentAugust 6, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Sleep Bruxism, Adult
Sponsor
Istanbul University
Enrollment
100
Locations
1
Primary Endpoint
occlusal force
Status
Completed
Last Updated
3 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
August 6, 2021
End Date
December 14, 2021
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Dr. Merve Benli

Assistant Professor

University of Pittsburgh

Eligibility Criteria

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).

Outcomes

Primary Outcomes

occlusal force

Time Frame: 2 months

Measuring maximum occlusal force by using digital gnatodynanometer

Sleep quality

Time Frame: 2 months

Evaluating sleep quality with Pittsburgh sleep quality index

Study Sites (1)

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