Occlusal Splints in the Treatment of Sleep Bruxism

NCT ID: NCT04934449

Last Updated: 2022-06-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-08-06
• Study Completion Date: 2021-12-14

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.

Conditions

Sleep Bruxism, Adult; Splints; Sleep

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: EXPERIMENTAL

Occlusal splint

Intervention Type: DEVICE

Using occlusal splints during sleep for 2 months

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

Group Type: EXPERIMENTAL

Occlusal splint

Intervention Type: DEVICE

Using occlusal splints during sleep for 2 months

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

Group Type: EXPERIMENTAL

Occlusal splint

Intervention Type: DEVICE

Using occlusal splints during sleep for 2 months

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

Group Type: EXPERIMENTAL

Occlusal splint

Intervention Type: DEVICE

Using occlusal splints during sleep for 2 months

Interventions

Occlusal splint

Using occlusal splints during sleep for 2 months

Intervention Type: DEVICE

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,

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Istanbul University

OTHER

Sponsor Role: lead

Responsible Party

Dr. Merve Benli

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Istanbul university,Faculty of Dentistry

Fatih, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 28601734 (View on PubMed)

Other Identifiers

1299

Identifier Type: -

Identifier Source: org_study_id