NCT07045441

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

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 300 (actual)
• Sponsor: Soaad Tolba Mohammed Tolba Badawi · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

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

Interventions

Type	Name	Description
OTHER	Conservative Management for TMD	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.

Timeline

• Start date: 2025-02-01
• Primary completion: 2025-06-01
• Completion: 2025-06-20
• First posted: 2025-07-01
• Last updated: 2025-07-03

Locations

1 site across 1 country: Egypt