Effects of Different Occlusal Splints

NCT06893744 | Completed

• 1 other identifier: 42/4
• Study Type: interventional
• Target: 49
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study was carried out on 49 patients with bruxism and 15 asymptomatic individuals (group 1, control), totally 64 subjects. The selection of patients with bruxism was based on International Classification of Sleep Disorders Sleep bruxism diagnostic criteria. 16 patients were treated with soft splint (group 2), 17 patients were treated with hard splint (group 3) and left 16 patients were treated with semi-soft splint (group 4). Joint vibration records were made with JVA (Biopak system BioResearch , Inc., Milwaukee, WI) device during the opening and closing movements. The recordings were made before and after occlusal splint treatment for three months in patients with bruxism. The recordings of individuals in control group was made two times at three months intervals. Also clinical evaluation was made with questionnaire forms. The study was approved by the ethical committee and each subject gave informed consent.

Conditions

Bruxism; Bruxism, Sleep; Occlusal Splints

Keywords

Bruxism; Occlusal Splints; Bruxism, Sleep; TMJ

Outcome Measures

Primary Outcomes (1)

• Vibration analysis resulting from the movement between temporomandibular joint surfaces with JVA (Joint Vibration Analysis) device

  Joint vibration analysis resulting from the movement between temporomandibular joint surfaces was performed by using a Joint Vibration Analysis device (BioPAK (BioResearch, Inc., Milwaukee, WI). Joint vibration analysis parameters were evaluated after occlusal splint treatments in patients with bruxism for each arm.

  3 days

Study Arms (3)

Soft Splint

EXPERIMENTAL

It is a type of occlusal splint using soft material. It was applied to bruxist patients in accordance with the study design (Group 2).

Device: occlusal splint

Hard Splint

EXPERIMENTAL

It is a type of occlusal splint using hard material. It was applied to bruxist patients in accordance with the study design (Group 3).

Device: occlusal splint

Semi-soft Splint

EXPERIMENTAL

It is a type of occlusal splint using semi-soft material. They cover the advantages of soft and hard occlusal splints. It was applied to bruxist patients in accordance with the study design (Group 4).

Device: occlusal splint

Interventions

occlusal splint DEVICE

Hard Splint; Semi-soft Splint; Soft Splint

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• The patient has a complaint of grinding/clenching during sleep
• One or more of the following occurs:
• abnormal wear of the teeth
• sounds associated with the bruxism
• jaw muscle discomfort
• No other medical or mental disorders that affecting masticatory muscles activity

You may not qualify if:

• Patients with missing at least 2 posterior teeth, except for the third molars
• Presence of Myofascial Pain Dysfunction (MPD)
• Presence of major neurological, psychiatric or motor disorders
• Patients using medications, influencing sleep or motor functions
• Patients with alcohol or drug addiction
• Patients ongoing any dental treatment
• Patients using occlusal splint or exposing the treatment for TMJ disorders in the last 3 months.
• Patients with pregnancy
• Patients with cancer
• Patients with scheduled surgery operation
• Patients with pericoronitis or supraeruption of 3rd molar

Sponsors & Collaborators

• Ankara University: lead

Related Publications (1)

• Akat B, Akoren AC, Tamam E. Effects of Different Occlusal Splints on Joint Vibrations in Bruxers. Medicina (Kaunas). 2025 Jun 12;61(6):1083. doi: 10.3390/medicina61061083.

  PMID: 40572771 DERIVED

MeSH Terms

Conditions

Bruxism; Sleep Bruxism

Interventions

Occlusal Splints

Condition Hierarchy (Ancestors)

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

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, OUTCOMES ASSESSOR
• Masking Details: Participants were blinded because they did not know the method of interventional treatment (occlusal splints) given to them. In addition, the outcome assessor was blinded because he assessed the patients with the occlusal splints out of their mouths. Therefore, this research had double blind study design.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 25, 2025
• Study Start: January 15, 2013
• Primary Completion: February 15, 2013
• Study Completion: August 15, 2014
• Last Updated: March 25, 2025

Record last verified: 2012-12