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

Soaad Tolba Mohammed Tolba Badawi

Status: Completed

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

Treatments: Other: Conservative Management for TMD

Study type: Observational

Funder types: Other

Identifiers

NCT07045441

RP.25.05.2

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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)

Trial design

300 participants in 1 patient group

TMD Patients Receiving Conservative Treatment

Description:

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.

Treatment:

Other: Conservative Management for TMD