Temporomandibular Disorders (TMDs)TMDNCT06783530
Psychological and Clinical Outcomes of Splint Therapy with and Without Doctor-Patient Communication in TMD Management
A study testing Splint Therapy with Enhanced Doctor-Patient Communication and Splint Therapy in people with Temporomandibular Disorders (TMDs), run by Soaad Tolba Mohammed Tolba Badawi at 1 site in Egypt.
Trial summary
This study aimed to evaluate the psychological and clinical outcomes of patients undergoing splint therapy with or without enhanced doctor-patient communication in the management of temporomandibular disorders (TMDs). Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Temporomandibular Disorders (TMDs)
- What is being tested?
- Splint Therapy with Enhanced Doctor-Patient Communication and Splint Therapy
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 435 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2023to 30 Oct 2024
- Phase
- Interventional
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months, who never underwent any type of treatment for TMD's.
- Age ≥16 years.
Who cannot join
- patients who have already undergone any treatment for TMD's, edentulous patients,
- patients with any systemic disease that could cause joint and/or muscle changes,
- patients who were undergoing drug treatment for the condition, current pregnancy, or breastfeeding.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Mansoura University
Al Mansurah, Dakahlia Governorate, 35516
About this study
Official title: Psychological and Clinical Outcomes After Splint Therapy with Versus Without Doctor-patient Communication Concept in the Management of TMDs
This study aimed to evaluate the psychological and clinical outcomes of patients undergoing splint therapy with or without enhanced doctor-patient communication in the management of temporomandibular disorders (TMDs). The study compared treatment approaches to determine their impact on patient satisfaction and clinical results.
Read the detailed description
Temporomandibular disorders (TMDs) are prevalent conditions characterized by jaw pain, functional limitations, and psychological distress. This study investigated the impact of splint therapy combined with enhanced doctor-patient communication on psychological well-being and clinical outcomes. Participants were randomly assigned to receive standard splint therapy or splint therapy with additional doctor-patient communication strategies. The primary outcomes include clinical and psychological status improvements, measured over six months, and patient satisfaction, assessed over a one-year period. The results aimed to provide insights into optimizing treatment strategies for TMD patients.
- Conditions
- Temporomandibular Disorders (TMDs)
- Being tested
- Splint Therapy with Enhanced Doctor-Patient Communication, Splint Therapy
- Keywords
- Splint Therapy, Doctor-Patient Communication, Non-Surgical TMD Treatment, TMDs management
- Medical subject headings
- Temporomandibular Joint Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splint Therapy with Enhanced Doctor-Patient CommunicationBehavioural
A structured communication protocol aimed at improving doctor-patient interaction and treatment adherence.
Splint TherapyDevice
A custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD).
| Study group | Role | What they receive |
|---|---|---|
| Splint Therapy with Enhanced Doctor-Patient Communication | Experimental | Participants in this arm received splint therapy along with structured doctor-patient communication to improve treatment outcomes. Receives: Behavioral: Splint Therapy with Enhanced Doctor-Patient Communication |
| Standard Splint Therapy | Active comparator | Participants in this group received standard splint therapy for the management of temporomandibular disorders (TMD). The splint was fitted and adjusted by a qualified clinician, and participants was monitored for outcomes such as pain reduction, jaw function, and patient satisfaction. Receives: Device: Splint Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Depression, Anxiety, and Stress levels
Depression, anxiety, and stress levels was measured using the 10-item Depression, Anxiety, and Stress Scale (DASS-10) at baseline and after six months of therapy. The DASS-10 comprises 10 items, each rated on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time").
- Minimum value: 0
- Maximum value: 30
- Interpretation: Higher scores indicate worse psychological outcomes.
Measured: Baseline to 6 months.
Change in Interincisal Mouth Opening
Maximum interincisal mouth opening was measured at baseline and after six months of therapy using a calibrated caliper.
Measured: Baseline to 6 months.
Change in Intra-articular pain (IAP)
Intra-articular pain was assessed at baseline and after six months using the Visual Analog Scale (VAS) for pain intensity. The scale ranged from 0 to 10, where:
- Minimum value: 0 (No pain)
- Maximum value: 10 (Worst possible pain).
Measured: Baseline to 6 months.
Change in Joint Sound Presence and Characteristics
Joint Sounds were measured in scores from 0 to 5, where 0 = no joint sound, 1 = Joint noise on occasion, 2 = palpable clicking, 3 = audible clicking, 4 = absence of previous clicking (closed lock), and 5 = crepitation. Assessment of the presence and characteristics of joint sounds was performed at baseline and after six months of therapy.
Measured: Baseline to 6 months.
Secondary outcomes (2)
Change in Masticatory Muscle Pain Intensity
Pain intensity in the masticatory muscles (e.g., masseter, temporalis, medial pterygoid, lateral pterygoid) was assessed by palpation at specific points, which uses a pain scale from zero to three (0: pressure only; 1: mild pain; 2: moderate pain; 3: severe pain). Pain assisted by palpation pressure (1kg pressure for 5sec) as defined in DC/TMD.
Measured: Baseline to 6 months.
Patient Satisfaction with Treatment
Each patient was evaluated at 6 and 12 months after intervention. The patient satisfaction questionnaire comprised two questions assessed using a 10-point Likert scale (1 = extremely dissatisfied to 10 = perfect/strongly satisfied).
- Overall satisfaction with the clinical result of the treatment.
- Satisfaction with the fulfillment of postoperative expectations.
Measured: From 6 months to 1-year post-intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2025
- Study start1 Jul 2023
- Primary completion15 Oct 2024
- Study completion30 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study used a parallel assignment model with two groups: one receiving standard splint therapy and the other receiving splint therapy with enhanced doctor-patient communication.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 435 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 of OMFS, MU, Principal investigator, Faculty of dentistry, Mansoura universityMai Ahmed Haggag, Assistant Professor of OMFS, Principal investigator, Faculty of dentistry, Mansoura universityChristine Raouf Micheal, Assistant Professor, Principal investigator, Prosthodontics Department, Faculty of dentistry, Mansoura university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06783530
- Sponsor's protocol ID
- A02012024OS
- Acronym
- TMD
- Status last verified
- Jan 2025
- First submitted
- 9 Jan 2025
- Last updated
- 20 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: At this time, no decision has been made regarding the sharing of Individual Participant Data (IPD). Data-sharing plans will be determined based on institutional guidelines, ethical considerations, and journal requirements at the time of publication.
Publications
de Barros Pascoal AL, de Freitas RFCP, da Silva LFG, Oliveira AGRC, Dos Santos Calderon P. Effectiveness of Counseling on Chronic Pain Management in Patients with Temporomandibular Disorders. J Oral Facial Pain Headache. 2020 Winter;34(1):77-82. doi: 10.11607/ofph.2163. Epub 2019 Apr 12.
PubMed 30978270Haggag MA, Ibrahim CRM, Badawy ST. Psychological and Clinical Outcomes After Splint Therapy With Versus Without Doctor-Patient Communication Concept in the Management of TMDs: A Randomised Controlled Clinical Trial. J Oral Rehabil. 2025 Oct;52(10):1651-1663. doi: 10.1111/joor.14005. Epub 2025 May 19.
PubMed 40384540
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Psychological and Clinical Outcomes After Splint Therapy with Versus Without Doctor-patient Communication Concept in the Management of TMDs
- ClinicalTrials.gov ID
- NCT06783530
- Acronym / sponsor ID
- TMD / A02012024OS
- Conditions
- Temporomandibular Disorders (TMDs)
- Keywords
- Splint Therapy, Doctor-Patient Communication, Non-Surgical TMD Treatment, TMDs management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 435 participants (actual)
- Lead sponsor
- Soaad Tolba Mohammed Tolba BadawiUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 30 Oct 2024 (actual)
- First posted
- 20 Jan 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.
This study aimed to evaluate the psychological and clinical outcomes of patients undergoing splint therapy with or without enhanced doctor-patient communication in the management of temporomandibular disorders (TMDs). The study compared treatment approaches to determine their impact on patient satisfaction and clinical results.
Detailed description
Temporomandibular disorders (TMDs) are prevalent conditions characterized by jaw pain, functional limitations, and psychological distress. This study investigated the impact of splint therapy combined with enhanced doctor-patient communication on psychological well-being and clinical outcomes. Participants were randomly assigned to receive standard splint therapy or splint therapy with additional doctor-patient communication strategies. The primary outcomes include clinical and psychological status improvements, measured over six months, and patient satisfaction, assessed over a one-year period. The results aimed to provide insights into optimizing treatment strategies for TMD patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- This study used a parallel assignment model with two groups: one receiving standard splint therapy and the other receiving splint therapy with enhanced doctor-patient communication.
| Arm | Type | Receives |
|---|---|---|
| Splint Therapy with Enhanced Doctor-Patient Communication | Experimental | Behavioral: Splint Therapy with Enhanced Doctor-Patient CommunicationParticipants in this arm received splint therapy along with structured doctor-patient communication to improve treatment outcomes. |
| Standard Splint Therapy | Active comparator | Device: Splint TherapyParticipants in this group received standard splint therapy for the management of temporomandibular disorders (TMD). The splint was fitted and adjusted by a qualified clinician, and participants was monitored for outcomes such as pain reduction, jaw function, and patient satisfaction. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- patients complaining of pain in the orofacial region (either arthrogenous and/or myogenous TMD) in the last 3 months, who never underwent any type of treatment for TMD's.
- Age ≥16 years.
Key exclusion criteria (3 listed)
- patients who have already undergone any treatment for TMD's, edentulous patients,
- patients with any systemic disease that could cause joint and/or muscle changes,
- patients who were undergoing drug treatment for the condition, current pregnancy, or breastfeeding.
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 |
|---|---|---|
| Splint Therapy with Enhanced Doctor-Patient CommunicationA structured communication protocol aimed at improving doctor-patient interaction and treatment adherence. | Behavioural | Splint Therapy with Enhanced Doctor-Patient Communication |
| Splint TherapyA custom-fitted occlusal splint designed to alleviate symptoms of temporomandibular disorders (TMD). | Device | Standard Splint Therapy |
Primary outcome
Change in Depression, Anxiety, and Stress levels
Time frame: Baseline to 6 months.
Depression, anxiety, and stress levels was measured using the 10-item Depression, Anxiety, and Stress Scale (DASS-10) at baseline and after six months of therapy. The DASS-10 comprises 10 items, each rated on a 4-point Likert scale ranging from 0 ("Did not apply to me at all") to 3 ("Applied to me very much or most of the time"). * Minimum value: 0 * Maximum value: 30 * Interpretation: Higher scores indicate worse psychological outcomes.
Change in Interincisal Mouth Opening
Time frame: Baseline to 6 months.
Maximum interincisal mouth opening was measured at baseline and after six months of therapy using a calibrated caliper.
Change in Intra-articular pain (IAP)
Time frame: Baseline to 6 months.
Intra-articular pain was assessed at baseline and after six months using the Visual Analog Scale (VAS) for pain intensity. The scale ranged from 0 to 10, where: * Minimum value: 0 (No pain) * Maximum value: 10 (Worst possible pain).
Change in Joint Sound Presence and Characteristics
Time frame: Baseline to 6 months.
Joint Sounds were measured in scores from 0 to 5, where 0 = no joint sound, 1 = Joint noise on occasion, 2 = palpable clicking, 3 = audible clicking, 4 = absence of previous clicking (closed lock), and 5 = crepitation. Assessment of the presence and characteristics of joint sounds was performed at baseline and after six months of therapy.
2 secondary outcomes
Change in Masticatory Muscle Pain Intensity
Time frame: Baseline to 6 months.
Patient Satisfaction with Treatment
Time frame: From 6 months to 1-year post-intervention.
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 20 Jan 2025.
- Background: PubMed 30978270de Barros Pascoal AL, de Freitas RFCP, da Silva LFG, Oliveira AGRC, Dos Santos Calderon P. Effectiveness of Counseling on Chronic Pain Management in Patients with Temporomandibular Disorders. J Oral Facial Pain Headache. 2020 Winter;34(1):77-82. doi: 10.11607/ofph.2163. Epub 2019 Apr 12.
- Derived from this study: PubMed 40384540Haggag MA, Ibrahim CRM, Badawy ST. Psychological and Clinical Outcomes After Splint Therapy With Versus Without Doctor-Patient Communication Concept in the Management of TMDs: A Randomised Controlled Clinical Trial. J Oral Rehabil. 2025 Oct;52(10):1651-1663. doi: 10.1111/joor.14005. Epub 2025 May 19.
- This link provides a collection of research articles related to splint therapy for temporomandibular disorders, which aligns with the focus of this study.Link provided by the sponsor.
- This link directs to a PubMed search for studies related to counselling as a treatment approach for temporomandibular disorders, which is relevant to this study's objectives.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided. At this time, no decision has been made regarding the sharing of Individual Participant Data (IPD). Data-sharing plans will be determined based on institutional guidelines, ethical considerations, and journal requirements at the time of publication.
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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 of OMFS, MU principal investigator
Faculty of dentistry, Mansoura university
Mai Ahmed Haggag, Assistant Professor of OMFS principal investigator
Faculty of dentistry, Mansoura university
Christine Raouf Micheal, Assistant Professor principal investigator
Prosthodontics Department, 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?
A study testing Splint Therapy with Enhanced Doctor-Patient Communication and Splint Therapy in people with Temporomandibular Disorders (TMDs), 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 2 inclusion and 3 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 20 Jan 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?
Change in Depression, Anxiety, and Stress levels (time frame: Baseline to 6 months.). The study lists 4 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 NCT06783530, which also lists 2 linked publications.
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 20 Jan 2025.