NCT06914388

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2024

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2024

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2024

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 17, 2025

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 28, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 6, 2025

Completed
Last Updated

April 6, 2025

Status Verified

March 1, 2025

Enrollment Period

2 months

First QC Date

March 28, 2025

Last Update Submit

April 4, 2025

Conditions

Keywords

BruxismSelf-Management StrategiesProprioceptionMuscle StiffnessPainTemporomandibular Joint Dysfunction

Outcome Measures

Primary Outcomes (5)

  • Bruxism Assessment

    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

    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

    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

    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

    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 Outcomes (2)

  • Temporomandibular Joint Position Sense

    8 weeks

  • Mandibular Depression Range of Motion

    8 weeks

Study Arms (1)

Self-Management

EXPERIMENTAL

Participants were recruited from individuals seeking treatment at a physiotherapy clinic.

Other: Self-Management Strategies

Interventions

Stretching exercises, strengthening exercises, massage, relaxing exercises, breathing exercises, patient education

Self-Management

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Turkey

Mersin, Lefkosa, 99040, Turkey (Türkiye)

Location

Related Publications (6)

  • Mesko ME, Hutton B, Skupien JA, Sarkis-Onofre R, Moher D, Pereira-Cenci T. Therapies for bruxism: a systematic review and network meta-analysis (protocol). Syst Rev. 2017 Jan 13;6(1):4. doi: 10.1186/s13643-016-0397-z.

    PMID: 28086992BACKGROUND
  • Micoogullari M, Yuksel I, Angin S. Efficacy of scapulothoracic exercises on proprioception and postural stability in cranio-cervico-mandibular malalignment: A randomized, double-blind, controlled trial. J Back Musculoskelet Rehabil. 2024;37(4):883-896. doi: 10.3233/BMR-230323.

    PMID: 38427467BACKGROUND
  • Winocur E, Uziel N, Lisha T, Goldsmith C, Eli I. Self-reported bruxism - associations with perceived stress, motivation for control, dental anxiety and gagging. J Oral Rehabil. 2011 Jan;38(1):3-11. doi: 10.1111/j.1365-2842.2010.02118.x.

    PMID: 20557433BACKGROUND
  • Koyano K, Tsukiyama Y, Ichiki R, Kuwata T. Assessment of bruxism in the clinic. J Oral Rehabil. 2008 Jul;35(7):495-508. doi: 10.1111/j.1365-2842.2008.01880.x.

    PMID: 18557916BACKGROUND
  • Manfredini D, Bucci MB, Sabattini VB, Lobbezoo F. Bruxism: overview of current knowledge and suggestions for dental implants planning. Cranio. 2011 Oct;29(4):304-12. doi: 10.1179/crn.2011.045.

    PMID: 22128671BACKGROUND
  • Feu D, Catharino F, Quintao CC, Almeida MA. A systematic review of etiological and risk factors associated with bruxism. J Orthod. 2013 Jun;40(2):163-71. doi: 10.1179/1465313312Y.0000000021.

    PMID: 23794697BACKGROUND

MeSH Terms

Conditions

BruxismPainTemporomandibular Joint Disorders

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic DiseasesHabitsBehaviorNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsCraniomandibular DisordersMandibular DiseasesJaw DiseasesMusculoskeletal DiseasesJoint DiseasesMuscular Diseases

Study Officials

  • Salih Angın, Prof. Dr.

    Cyprus International University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
All treatments were administered by the same physiotherapist. All assessments were carried out by a physiotherapist who was blinded to the treatment.
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Interventional Study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asst. Prof. Dr.

Study Record Dates

First Submitted

March 28, 2025

First Posted

April 6, 2025

Study Start

July 3, 2024

Primary Completion

August 20, 2024

Study Completion

February 17, 2025

Last Updated

April 6, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations