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NCT Number: NCT07045441

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

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.

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Key information

Conditions

Temporomandibular Disorders (TMDs) Behavior Behavioral Counseling Craniomandibular Disorders Health Behavior Jaw Diseases Joint Diseases Mandibular Diseases Muscular Diseases Musculoskeletal Diseases Splint Therapy Stomatognathic Diseases Temporomandibular Joint Disorders Treatment Adherence and Compliance

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, 35511, Egypt

About this study

This observational study aims to validate a newly developed adherence questionnaire tailored to measure patient compliance with conservative treatment protocols of TMDs, including splint therapy and behavioral counseling. The questionnaire was developed in both Arabic and English and underwent content validation, pilot testing, and psychometric evaluation.

Participants included in the study are individuals already undergoing treatment for TMD, specifically splint therapy and counseling, as part of their standard clinical care. The study does not assign any interventions but focuses on collecting data through patient-reported responses to the adherence questionnaire.

Data collected will be used to assess the questionnaire's reliability, validity, and factor structure to establish it as a robust tool for clinical and research settings. The outcomes of this study are expected to support the identification of non-adherent patients and facilitate targeted interventions to enhance treatment outcomes.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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)

Treatment and study plan

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.

Primary outcomes

  1. Content Validity of the Adherence Questionnaire

    Time frame: Preceding patient data collection (before pilot phase)

    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

  2. Internal Consistency of the Adherence Questionnaire

    Time frame: Baseline (after 6 months of treatment)

    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

Secondary outcomes

  1. Test-Retest Reliability of the Adherence Questionnaire

    Time frame: 1-week interval after baseline administration

    Assessment of temporal stability using Intraclass Correlation Coefficient (ICC) between two administrations of the questionnaire, 1 week apart.

    Unit of Measure: ICC

  2. Construct Validity via Exploratory Factor Analysis (EFA)

    Time frame: Baseline (after 6 months of treatment)

    Evaluation of construct validity through Exploratory Factor Analysis to identify the underlying factor structure.

    Unit of Measure: Number of factors extracted and percent variance explained

Sponsors and collaborators

Lead sponsor

Soaad Tolba Mohammed Tolba Badawi

Other

Registry information

Official study title

Patient Adherence to Splint Therapy and Counseling Programs in Temporomandibular Disorders: Development and Validation of a New Questionnaire

Acronym: TMDs

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2025
Registry last updated
Jul 3, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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