Temporomandibular Disorders (TMDs)TMDsNCT07045441
Development and Validation of a Temporomandibular Disorders (TMDs) Adherence Questionnaire
An observational study of Temporomandibular Disorders (TMDs) and Splint Therapy, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMDs), Splint Therapy, Behavioral Counseling
- What is being tested?
- Conservative Management for TMD
- How many people
- 300 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Feb 2025to 20 Jun 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with TMDs who have completed six months of conservative treatment, including splint therapy and behavioral counseling.
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35511
About this study
Official title: Patient Adherence to Splint Therapy and Counseling Programs in Temporomandibular Disorders: Development and Validation of a New 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.
Read the 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
- Being tested
- Conservative Management for TMD
- Keywords
- Temporomandibular joint disorder, TMD adherence, Splint compliance, Counseling adherence, Psychometric validation, Questionnaire development, Conservative TMD treatment
- Medical subject headings
- Temporomandibular Joint Disorders, Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conservative Management for TMDOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Conservative Management for TMD |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Baseline (after 6 months of treatment)
Secondary outcomes (2)
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
Measured: 1-week interval after baseline administration
Construct Validity via Exploratory Factor Analysis (EFA)
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
Measured: Baseline (after 6 months of treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start1 Feb 2025
- Primary completion1 Jun 2025
- Study completion20 Jun 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Temporomandibular Disorders (TMDs)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- Soaad Tolba Mohammed Tolba Badawi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Soaad Tolba Mohammed Tolba Badawi, Mansoura University
- Investigators
- Soaad Tolba Badawy, Lecturer, Oral Surgery, MU, Principal investigator, Faculty of dentistry, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07045441
- Sponsor's protocol ID
- RP.25.05.2
- Acronym
- TMDs
- Status last verified
- Jun 2025
- First submitted
- 22 Jun 2025
- Last updated
- 3 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The decision regarding sharing of individual participant data (IPD) has not yet been finalized. Further details will be provided when available
Publications
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.
PubMed 41578714
Study at a glance
From the registry record, last updated by the sponsor on 3 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient Adherence to Splint Therapy and Counseling Programs in Temporomandibular Disorders: Development and Validation of a New Questionnaire
- ClinicalTrials.gov ID
- NCT07045441
- Acronym / sponsor ID
- TMDs / RP.25.05.2
- Conditions
- Temporomandibular Disorders (TMDs), Splint Therapy, Behavioral Counseling, Treatment Adherence and Compliance
- Keywords
- Temporomandibular joint disorder, TMD adherence, Splint compliance, Counseling adherence, Psychometric validation, Questionnaire development, Conservative TMD treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 1 Jun 2025 (actual)
- Study completion
- 20 Jun 2025 (actual)
- First posted
- 1 Jul 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TMD Patients Receiving Conservative Treatment | – | Other: Conservative Management for TMDThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with TMDs who have completed six months of conservative treatment, including splint therapy and behavioral counseling.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conservative Management for TMDThis 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. | Other | TMD Patients Receiving Conservative Treatment |
Primary outcome
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
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
2 secondary outcomes
Test-Retest Reliability of the Adherence Questionnaire
Time frame: 1-week interval after baseline administration
Construct Validity via Exploratory Factor Analysis (EFA)
Time frame: Baseline (after 6 months of treatment)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jul 2025.
- Derived from this study: PubMed 41578714Badawy 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.
- Individual participant dataSharing planned: Undecided. 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Soaad Tolba Badawy, Lecturer, Oral Surgery, MU principal investigator
Faculty of dentistry, Mansoura university
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Temporomandibular Disorders (TMDs) and Splint Therapy, run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Content Validity of the Adherence Questionnaire (time frame: Preceding patient data collection (before pilot phase)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07045441, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jul 2025.