Impact of Self-Management Strategies in Self-Reported Bruxism

April 4, 2025 updated by: Mehmet Miçooğulları, Cyprus International University

Effects of Self-Management Strategies on Pain, Muscle Stiffness and Temporomandibular Joint Functions in Individuals With Bruxism

This study aim to evaluate the effects of a 6-week self-management program on pain, muscle stiffness, and temporomandibular joint (TMJ) functions in sedentary individuals aged 18-40 with bruxism. Thirty-five individuals will be evaluated. Bruxism will be assessed using the Bruxism Assessment Questionnaire, while temporomandibular joint dysfunction (TMJD) will be evaluated using the Helkimo Clinical Dysfunction Index and the Fonseca Questionnaire. Masseter muscle pain threshold will be measured with a digital algometer, muscle stiffness with a Shore Durometer, mandibular depression range of motion with a bicondylar caliper, and TMJ proprioception with TMJ position sense. Assessments will be conducted pre-intervention and at the end of the fourth week.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The 4-week self-management program significantly increased the masseter pain threshold (p<0.001) and reduced muscle stiffness at rest and during contraction (p<0.001). TMJD severity, as measured by the Helkimo Index (p=0.010) and Fonseca Questionnaire (p<0.001), was significantly reduced. Additionally, TMJ position sense and mandibular depression range of motion improved significantly (p<0.001). Self-management strategies positively impact bruxism symptoms, including pain, muscle stiffness, and TMJ functions. These strategies should be considered an integral part of TMJD and bruxism management.

Study Type

Interventional

Enrollment (Actual)

35

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Lefkosa
      • Mersin, Lefkosa, Turkey, 99040
        • Turkey

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Adults aged 18 to 40 years
  • Sedentary lifestyle
  • Clinical diagnosis of sleep and/or awake bruxism

Exclusion Criteria:

  • Significant musculoskeletal disorders of the cervical or thoracic spine
  • Chronic illnesses
  • Neurological conditions affecting balance and postural control
  • Pregnancy
  • The presence of dental prostheses
  • Participants who missed more than 15 sessions

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Self-Management
Participants were recruited from individuals seeking treatment at a physiotherapy clinic.
Other: Self-Management Strategies
Stretching exercises, strengthening exercises, massage, relaxing exercises, breathing exercises, patient education

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bruxism Assessment
Time Frame: 8 weeks
Bruxism will be assessed using self-reports, which are considered appropriate for both clinical and research purposes. Awake bruxism will be diagnosed based on participants' self-awareness, determined by asking whether they had noticed clenching or grinding their teeth while awake in the past six months. Individuals who respond affirmatively will be classified as having awake bruxism. Sleep bruxism will be diagnosed using the 2014 criteria established by the American Academy of Sleep Medicine (AASM). Participants will be asked whether they frequently noticed teeth grinding during sleep, will be informed of it by others, or observed excessive tooth wear. Additionally, they will be questioned about symptoms upon waking, such as jaw fatigue, tension, or pain; sensations of clenching or pain in the mouth; temple pain; difficulty opening the mouth; tension in the jaw joint requiring movement to release; or clicking sounds in the jaw joint that disappear afterward.
8 weeks
Temporomandibular Joint Dysfunction
Time Frame: 8 weeks
Temporomandibular Joint Disorder (TMJD) will be evaluated using the Helkimo Clinical Dysfunction Index (HCDI). This instrument is considered valid and reliable measures of TMJD. The scoring system categorises participants into four groups: no clinical symptoms (score 0), mild TMJD (scores 1-4), moderate TMJD (scores 5-9), and severe TMJD (scores 10-25)
8 weeks
Temporomandibular Joint Dysfunction
Time Frame: 8 weeks
Temporomandibular Joint Disorder (TMJD) will be evaluated using the Fonseca Questionnaire. This instrument is considered valid and reliable measures of TMJD. Participants will be instructed to respond to each question as 'yes' (10 points), 'no' (0 points), or 'sometimes' (5 points). The questionnaire results will be classified as no TMJD (0-15), mild TMJD (20-40), moderate TMJD (45-65), and severe TMJD (70-100) based on the responses provided by the participants.
8 weeks
Masseter Muscle Pain Threshold Measurement
Time Frame: 8 weeks
The pain threshold of the masseter muscle will be assessed bilaterally over the muscle belly using a JTECH Commander digital algometer. Three measurements will be taken from the muscle belly, and the average value will be calculated. Participants will be instructed to indicate the moment they first perceived pain, and the value will be display on the device will be recorded as the pain threshold in pounds. Higher scores indicate better pain threshold.
8 weeks
Masseter Muscle Stiffness
Time Frame: 8 weeks
The stiffness of the masseter muscle will be assessed using a Shore Durometer OO (M&A Instruments Inc., United States), a handheld device designed for convenient and non-invasive measurement of muscle stiffness. The durometer evaluates tissue properties by measuring oscillations generated through mechanical contact with the assessed muscle. Measurements will be performed bilaterally over the belly of the masseter muscle during both resting and maximum contraction states. Each measurement will be repeated three times, and the average values will be recorded in Newtons per meter.
8 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Temporomandibular Joint Position Sense
Time Frame: 8 weeks
The measurement of TMJPS will be conducted using 9 test sticks ranging from 4 mm to 8 mm in thickness, with 0.5 mm increments. A 6 mm thick wooden bar will be used as a reference. Participants first bit the 6 mm reference stick with their front teeth for 1 minute to familiarize themselves with the reference thickness. Subsequently, they will be asked to bite each of the 9 test sticks in a random order and compare their thickness to the reference stick. Each test stick will be presented 5 times, resulting in a total of 45 tests. Participants will indicate whether the test stick felt "thinner," "thicker," or "equal" compared to the reference stick. During the test, participants' eyes will be closed, and their responses will be recorded as correct (1 point) or incorrect (0 points). Total scores will be calculated for analysis.
8 weeks
Mandibular Depression Range of Motion
Time Frame: 8 weeks
The range of motion for mandibular depression will be assessed by evaluating the maximum mouth opening. Participants will be instructed to open their mouths as wide as possible. The distance between the lower and upper central incisors will be measured using a bicondylar caliper (Holtain Ltd., UK) and will be recorded in centimeters (cm). Each measurement will be repeated three times, and the average value will be calculated.
8 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cyprus International University

Investigators

  • Study Chair: Salih Angın, Prof. Dr., Cyprus International University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 3, 2024

Primary Completion (Actual)

August 20, 2024

Study Completion (Actual)

February 17, 2025

Study Registration Dates

First Submitted

March 28, 2025

First Submitted That Met QC Criteria

April 4, 2025

First Posted (Actual)

April 6, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2025

Last Update Submitted That Met QC Criteria

April 4, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 020-5790

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Pain

Clinical Trials on Self-Management Strategies

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Armenia

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe