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

NCT ID: NCT07045441

Last Updated: 2025-07-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 300 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2025-06-20

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

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.

Conservative Management for TMD

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Soaad Tolba Mohammed Tolba Badawi

OTHER

Sponsor Role: lead

Responsible Party

Soaad Tolba Mohammed Tolba Badawi

Lecturer of Oral and Maxillofacial Surgery, Faculty of Dentistry, Mansoura University, Egypt

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Soaad Tolba Badawy, Lecturer, Oral Surgery, MU

Role: PRINCIPAL_INVESTIGATOR

Faculty of dentistry, Mansoura university

Locations

Faculty of Dentistry, Mansoura University

Al Mansurah, Dakahlia Governorate, Egypt

Countries

Egypt

Other Identifiers

RP.25.05.2

Identifier Type: -

Identifier Source: org_study_id