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Occlusal Splints in the Treatment of Sleep Bruxism (bruxism)

Primary Purpose

Sleep Bruxism, Adult, Splints, Sleep

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Occlusal splint
Sponsored by
Istanbul University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sleep Bruxism, Adult focused on measuring sleep quality, occlusal splint, bruxism

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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,

Sites / Locations

  • Istanbul university,Faculty of Dentistry

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

Hard splint group- 2 mm thicknesss

Hard splint group- 3 mm thicknesss

Soft splint group- 2 mm thicknesss

Soft splint group- 3 mm thicknesss

Arm Description

This group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep

This group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep

This group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep

This group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep

Outcomes

Primary Outcome Measures

Sleep quality
Evaluating sleep quality with Pittsburgh sleep quality index
occlusal force
Measuring maximum occlusal force by using digital gnatodynanometer

Secondary Outcome Measures

Full Information

First Posted
June 16, 2021
Last Updated
June 20, 2022
Sponsor
Istanbul University
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1. Study Identification

Unique Protocol Identification Number
NCT04934449
Brief Title
Occlusal Splints in the Treatment of Sleep Bruxism
Acronym
bruxism
Official Title
The Effect of Occlusal Splint Type on Sleep Quality and Occlusal Force in Patients With Sleep Bruxism
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2021 (Actual)
Primary Completion Date
December 12, 2021 (Actual)
Study Completion Date
December 14, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istanbul University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sleep Bruxism, Adult, Splints, Sleep
Keywords
sleep quality, occlusal splint, bruxism

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized clinical trial
Masking
ParticipantInvestigator
Masking Description
Blinding the participants and investigator to the splint types employed in patients
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hard splint group- 2 mm thicknesss
Arm Type
Experimental
Arm Description
This group of patients was allocated to use 2 mm-thickness, hard occlusal splints for 2 months during sleep
Arm Title
Hard splint group- 3 mm thicknesss
Arm Type
Experimental
Arm Description
This group of patients was allocated to use 3 mm-thickness, hard occlusal splints for 2 months during sleep
Arm Title
Soft splint group- 2 mm thicknesss
Arm Type
Experimental
Arm Description
This group of patients was allocated to use 2 mm-thickness, soft occlusal splints for 2 months during sleep
Arm Title
Soft splint group- 3 mm thicknesss
Arm Type
Experimental
Arm Description
This group of patients was allocated to use 3 mm-thickness, soft occlusal splints for 2 months during sleep
Intervention Type
Device
Intervention Name(s)
Occlusal splint
Intervention Description
Using occlusal splints during sleep for 2 months
Primary Outcome Measure Information:
Title
Sleep quality
Description
Evaluating sleep quality with Pittsburgh sleep quality index
Time Frame
2 months
Title
occlusal force
Description
Measuring maximum occlusal force by using digital gnatodynanometer
Time Frame
2 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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). 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,
Facility Information:
Facility Name
Istanbul university,Faculty of Dentistry
City
Fatih
ZIP/Postal Code
34452
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
28601734
Citation
Rosar JV, Barbosa TS, Dias IOV, Kobayashi FY, Costa YM, Gaviao MBD, Bonjardim LR, Castelo PM. Effect of interocclusal appliance on bite force, sleep quality, salivary cortisol levels and signs and symptoms of temporomandibular dysfunction in adults with sleep bruxism. Arch Oral Biol. 2017 Oct;82:62-70. doi: 10.1016/j.archoralbio.2017.05.018. Epub 2017 May 27.
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Occlusal Splints in the Treatment of Sleep Bruxism

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