Development and Validation of a Temporomandibular Disorders (TMDs) Adherence Questionnaire

NCT07045441 | Completed

• 1 other identifier: RP.25.05.2
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this observational study is to assess patient adherence to splint therapy and behavioral counseling among individuals diagnosed with TMDs. The study uses a newly developed bilingual (Arabic and English) questionnaire to evaluate adherence behaviors. The main question it aims to answer is: How consistently do TMDs patients follow conservative treatment protocols, including splint use and counseling recommendations? Participants who are already receiving splint therapy and counseling as part of their standard care will complete the questionnaire to help researchers validate the tool and understand adherence patterns. Last updated on June 20, 2025.

Conditions

Temporomandibular Disorders (TMDs); Splint Therapy; Behavioral Counseling; Treatment Adherence and Compliance

Keywords

Temporomandibular joint disorder; TMD adherence; Splint compliance; Counseling adherence; Psychometric validation; Questionnaire development; Conservative TMD treatment

Outcome Measures

Primary Outcomes (2)

• Content Validity of the Adherence Questionnaire

  Assessment of content validity using expert panel ratings to compute Item Content Validity Index (I-CVI) and Content Validity Ratio (CVR). Unit of Measure: I-CVI and CVR values

  Preceding patient data collection (before pilot phase)

• Internal Consistency of the Adherence Questionnaire

  Evaluation of the internal consistency of the items of adherence questionnaire using Cronbach's alpha across all domains and total score. Unit of Measure: Cronbach's alpha coefficient

  Baseline (after 6 months of treatment)

Secondary Outcomes (2)

• Test-Retest Reliability of the Adherence Questionnaire

  1-week interval after baseline administration

• Construct Validity via Exploratory Factor Analysis (EFA)

  Baseline (after 6 months of treatment)

Study Arms (1)

TMD Patients Receiving Conservative Treatment

This cohort includes patients diagnosed with TMDs who received conservative treatment (splint therapy and behavioral counseling) for at least 6 months prior to participation. Adherence data were collected retrospectively through a structured questionnaire.

Other: Conservative Management for TMD

Interventions

Conservative Management for TMD OTHER

This intervention includes a standardized conservative treatment protocol for TMDs, comprising splint therapy and a structured counseling program. The counseling covers education on diagnosis, medication adherence, dietary modifications, posture and behavior correction, sleep hygiene, parafunctional habit avoidance, physiotherapy exercises, pain and stress management, and importance of follow-up visits. Patients receive individualized instructions and monitoring as part of their routine clinical care. Adherence to these components is measured after 6 months of treatment using a validated adherence questionnaire.

TMD Patients Receiving Conservative Treatment

Eligibility Criteria

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

Study Population

Patients diagnosed with TMDs who have completed six months of conservative treatment, including splint therapy and behavioral counseling.

You may qualify if:

• Adults aged 18 years and older
• Diagnosed with TMDs based on DC/TMD criteria
• Completed at least 6 months of conservative treatment (e.g., splint therapy and counseling program)
• Able to read and understand Arabic or English
• Provided informed consent

You may not qualify if:

• History of Temporomandibular joint (TMJ) surgery
• Currently undergoing other TMD-related treatments
• Presence of systemic musculoskeletal disorders (e.g., fibromyalgia, rheumatoid arthritis)
• Cognitive or psychiatric disorders impairing ability to participate
• Incomplete treatment duration (less than 6 months)

Sponsors & Collaborators

• Soaad Tolba Mohammed Tolba Badawi: lead

Study Sites (1)

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

Location

Related Publications (1)

• Badawy ST, Badawi AT, Haggag MA. Patient Adherence to Splint Therapy and Counselling Programmes in Temporomandibular Disorders: Development and Validation of a New Questionnaire. J Oral Rehabil. 2026 Jan 24. doi: 10.1111/joor.70153. Online ahead of print.

  PMID: 41578714 DERIVED

MeSH Terms

Conditions

Temporomandibular Joint Disorders; Treatment Adherence and Compliance

Interventions

Conservative Treatment

Condition Hierarchy (Ancestors)

Craniomandibular Disorders; Mandibular Diseases; Jaw Diseases; Musculoskeletal Diseases; Joint Diseases; Muscular Diseases; Stomatognathic Diseases; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

• Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

  Faculty of dentistry, Mansoura university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Egypt

Study Record Dates

• First Submitted: June 22, 2025
• First Posted: July 1, 2025
• Study Start: February 1, 2025
• Primary Completion: June 1, 2025
• Study Completion: June 20, 2025
• Last Updated: July 3, 2025

Record last verified: 2025-06

Locations

EG (1)