Effects of a Biopsychosocial Approach Added to Physiotherapy in Temporomandibular Disorders

NCT07320144 | Not Yet Recruiting DMC

• 2 other identifiers: TMD-BPS-20252025310
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

Temporomandibular disorders are conditions that affect the jaw joint and surrounding muscles and may cause pain, limited jaw movement, stress, sleep problems, and teeth grinding. Physiotherapy is commonly used to manage these problems, but psychological and social factors may also influence symptoms. The purpose of this study is to examine whether adding a biopsychosocial approach to physiotherapy improves stress levels, sleep quality, and bruxism in individuals with temporomandibular disorders. Participants will receive either physiotherapy alone or physiotherapy combined with education about pain, stress management, and sleep habits. The results of this study may help improve treatment strategies for people with temporomandibular disorders.

Conditions

Temporomandibular Disorders (TMD)

Keywords

Temporomandibular joint; Pain education; Bruxism; Sleep quality; Biopsychosocial approach

Outcome Measures

Primary Outcomes (1)

• Stress Level

  Stress level will be assessed using a validated self-reported questionnaire to evaluate perceived stress in individuals with temporomandibular disorders.

  Baseline and 6 weeks

Secondary Outcomes (2)

• Sleep Disturbance

  Baseline and 6 weeks

• Bruxism Severity

  Baseline and 6 weeks

Study Arms (2)

Physiotherapy

ACTIVE COMPARATOR

Participants in this arm will receive a standardized physiotherapy program for temporomandibular disorders, including therapeutic exercises and manual therapy targeting the temporomandibular joint and associated musculoskeletal structures.

Other: Physiotherapy Program

Physiotherapy Plus Biopsychosocial Approach

EXPERIMENTAL

Participants in this arm will receive the same physiotherapy program combined with a biopsychosocial intervention including pain education, stress management strategies, and sleep hygiene education.

Other: Physiotherapy Program; Other: Biopsychosocial Intervention

Interventions

Physiotherapy Program OTHER

A standardized physiotherapy program including therapeutic exercises and manual therapy targeting the temporomandibular joint and related musculoskeletal structures.

Physiotherapy; Physiotherapy Plus Biopsychosocial Approach

Biopsychosocial Intervention OTHER

A biopsychosocial intervention including pain neuroscience education, stress management strategies, and sleep hygiene education.

Physiotherapy Plus Biopsychosocial Approach

Eligibility Criteria

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

You may qualify if:

• Diagnosed with temporomandibular disorders
• Age between 18 and 65 years
• Presence of stress, sleep disturbance, or bruxism symptoms
• Ability to understand and follow study instructions
• Willingness to participate and provide informed consent

You may not qualify if:

• History of temporomandibular joint surgery
• Presence of neurological, rheumatological, or systemic diseases affecting the musculoskeletal system
• Current orthodontic treatment
• Use of medications that may affect pain perception or sleep
• Pregnancy

Sponsors & Collaborators

• Betül Özata: lead

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Bruxism; Sleep Initiation and Maintenance Disorders

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Tooth Diseases; Habits; Behavior; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Central Study Contacts

Betül Özata, MSc

CONTACT

+905395669393; ptbetulozata@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Physiotherapist, MSc Student

Model Details: Participants will be randomly assigned to either physiotherapy alone or physiotherapy combined with a biopsychosocial approach.

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 6, 2026
• Study Start: January 15, 2026
• Primary Completion: April 15, 2026
• Study Completion (Estimated): May 15, 2026
• Last Updated: January 6, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share