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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Test-Retest Reliability of the Adherence Questionnaire | Assessment of temporal stability using Intraclass Correlation Coefficient (ICC) between two administrations of the questionnaire, 1 week apart. Unit of Measure: ICC | 1-week interval after baseline administration |
| Construct Validity via Exploratory Factor Analysis (EFA) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with TMDs who have completed six months of conservative treatment, including splint therapy and behavioral counseling.
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| Name | Affiliation | Role |
|---|---|---|
| Soaad Tolba Badawy, Lecturer, Oral Surgery, MU | Faculty of dentistry, Mansoura university | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Faculty of Dentistry, Mansoura University | Al Mansurah | Dakahlia Governorate | 35511 | Egypt |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41578714 | Derived | 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 May;53(5):988-998. doi: 10.1111/joor.70153. Epub 2026 Jan 24. |
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The decision regarding sharing of individual participant data (IPD) has not yet been finalized. Further details will be provided when available
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| ID | Term |
|---|---|
| D013705 | Temporomandibular Joint Disorders |
| D000074822 | Treatment Adherence and Compliance |
| ID | Term |
|---|---|
| D017271 | Craniomandibular Disorders |
| D008336 | Mandibular Diseases |
| D007571 | Jaw Diseases |
| D009140 | Musculoskeletal Diseases |
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| ID | Term |
|---|---|
| D000072700 | Conservative Treatment |
| ID | Term |
|---|---|
| D013812 | Therapeutics |
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|
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 |
| Baseline (after 6 months of treatment) |
| D007592 |
| Joint Diseases |
| D009135 | Muscular Diseases |
| D009057 | Stomatognathic Diseases |
| D015438 | Health Behavior |
| D001519 | Behavior |