Occlusal Splints in the Treatment of Sleep Bruxism

NCT04934449 | Completed DMC

• 1 other identifier: 1299
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Sleep Bruxism, Adult; Splints; Sleep

Keywords

sleep quality; occlusal splint; bruxism

Outcome Measures

Primary Outcomes (2)

• Sleep quality

  Evaluating sleep quality with Pittsburgh sleep quality index

  2 months

• occlusal force

  Measuring maximum occlusal force by using digital gnatodynanometer

  2 months

Study Arms (4)

Hard splint group- 2 mm thicknesss

EXPERIMENTAL

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

Device: Occlusal splint

Hard splint group- 3 mm thicknesss

EXPERIMENTAL

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

Device: Occlusal splint

Soft splint group- 2 mm thicknesss

EXPERIMENTAL

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

Device: Occlusal splint

Soft splint group- 3 mm thicknesss

EXPERIMENTAL

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

Device: Occlusal splint

Interventions

Occlusal splint DEVICE

Using occlusal splints during sleep for 2 months

Hard splint group- 2 mm thicknesss; Hard splint group- 3 mm thicknesss; Soft splint group- 2 mm thicknesss; Soft splint group- 3 mm thicknesss

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \- Healthy participants with complete permanent dentition.

You may not qualify if:

• 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,

Sponsors & Collaborators

• Istanbul University: lead

Study Sites (1)

Istanbul university,Faculty of Dentistry

Fatih, 34452, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 28601734 BACKGROUND

MeSH Terms

Conditions

Sleep Bruxism; Sleep Initiation and Maintenance Disorders; Bruxism

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Parasomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Habits; Behavior

Intervention Hierarchy (Ancestors)

Orthotic Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Blinding the participants and investigator to the splint types employed in patients
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Randomized clinical trial

Study Record Dates

• First Submitted: June 16, 2021
• First Posted: June 22, 2021
• Study Start: August 6, 2021
• Primary Completion: December 12, 2021
• Study Completion: December 14, 2021
• Last Updated: June 22, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)