Temporomandibular Joint DisordersNCT06774196
Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria
A study testing Behavioral Therapy Group in people with Temporomandibular Joint Disorders and Chronic Pain, run by King Khalid University at 1 site in Saudi Arabia.
Trial summary
This study evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disorders, Chronic Pain, Anxiety Disorders
- What is being tested?
- Behavioral Therapy Group
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 5 Mar 2025to 5 Mar 2025
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 18-65 years.
- Diagnosed with Temporomandibular Disorders (TMD) based on DC/TMD Axis I and Axis II criteria.
- Presenting with symptoms such as jaw pain, limited jaw movement, or psychosocial distress (anxiety, depression).
- Willing and able to provide informed consent.
- Able to comply with the study protocol and attend all follow-up visits.
Who cannot join
- Severe systemic diseases or other neurological conditions that could interfere with treatment or outcomes.
- History of psychiatric disorders unrelated to TMD, such as schizophrenia or bipolar d disorder.
- Pregnant or lactating women.
- Use of medications or treatments within the past month that could influence study outcomes (e.g., corticosteroids, strong analgesics).
- Individuals with severe dental or maxillofacial conditions requiring immediate surgical intervention.
- Non-compliance with previous medical advice or treatment for TMD. Participants unable to understand or follow the study procedures due to language barriers or cognitive impairments.
Trial locations and contacts
1 site in 1 country.
About this study
This study evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). It aims to address both the physical and psychological aspects of TMD, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. Participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. Outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. This research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of TMD.
- Being tested
- Behavioral Therapy Group, Standard Care Group
- Keywords
- Temporomandibular Disorders, Temporomandibular Joint, Cognitive Behavioral Therapy
- Medical subject headings
- Temporomandibular Joint Disorders, Chronic Pain, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Therapy GroupBehavioural
Includes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback.
Standard Care GroupProcedure or surgery
Includes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions
| Study group | Role | What they receive |
|---|---|---|
| Behavioral Therapy Group | Experimental | Participants receiving behavioral therapy (Cognitive Behavioral Therapy, relaxation techniques, and biofeedback). Receives: Behavioral: Behavioral Therapy Group |
| Standard Care Group | Active comparator | Participants will receive standard care, consisting of pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy. Receives: Procedure: Standard Care Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Intensity
Assesses changes in self-reported pain levels with scores ranging from 0 (no pain) to 10 (worst pain)levels (0 = no pain, 10 = worst pain)
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Psychological Distress (Anxiety)
Measures depression levels with a score based on the frequency and severity of symptoms.
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Psychological Distress (Depression)
Measures depression levels with a score based on the frequency and severity of symptoms.
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Secondary outcomes (4)
Maximum Mouth Opening
Measures the maximum distance (in millimeters) between the upper and lower front teeth during maximum voluntary opening.
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Jaw Range of Motion
Assesses the range of motion of the jaw through physical examination, measuring angular movement in degrees.
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Pain-Related Disability
Assessed using the TMD Pain Disability Index (TDI) to evaluate the impact of pain on daily activities and quality of life
Measured: Baseline, 8 weeks post-treatment, and 6-month follow-up
Long-Term Symptom Relief
Sustained improvement in pain, jaw function, and psychological distress over time, assessed using VAS, GAD-7, PHQ-9, and TDI scores.
Measured: 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2025
- Study start5 Mar 2025
- Primary completion5 Mar 2025
- Study completion5 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint DisordersStudies 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
- Masking
- None (open label)
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Khalid University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sunil Kumar Vaddamanu, King Khalid University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06774196
- Sponsor's protocol ID
- ECM#2024-3196
- Status last verified
- Jan 2025
- First submitted
- 2 Jan 2025
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) from this study will not be shared with other researchers. This decision is based on the need to protect participant privacy and confidentiality, as well as the sensitive nature of the data collected, including psychological and health-related information. Although the study results will be shared in aggregated and anonymized formats through publications and presentations, no raw or identifiable participant data will be disclosed to external parties. This approach ensures compliance with ethical guidelines and data protection regulations.
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrating Behavioral Therapy in the Management of Temporomandibular Disorders: A Comprehensive Evaluation Using DC/TMD Axis II Criteria
- ClinicalTrials.gov ID
- NCT06774196
- Acronym / sponsor ID
- ECM#2024-3196
- Keywords
- Temporomandibular Disorders, Temporomandibular Joint, Cognitive Behavioral Therapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- King Khalid UniversityUniversity, hospital or other
- Study start
- 5 Mar 2025 (actual)
- Primary completion
- 5 Mar 2025 (actual)
- Study completion
- 5 Mar 2025 (actual)
- First posted
- 14 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 evaluates the efficacy of behavioral therapy, including Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback, in managing Temporomandibular Disorders (TMD). It aims to address both the physical and psychological aspects of TMD, focusing on pain reduction, improved jaw function, and alleviating psychological distress such as anxiety and depression. Participants are randomized into two groups: an intervention group receiving behavioral therapy and a control group receiving standard care. Outcomes will be assessed using validated tools to measure pain intensity, jaw function, and psychological well-being at baseline, post-treatment, and at a 6-month follow-up. This research seeks to establish the role of behavioral therapy as a key component in the comprehensive management of TMD.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Behavioral Therapy Group | Experimental | Behavioral: Behavioral Therapy GroupParticipants receiving behavioral therapy (Cognitive Behavioral Therapy, relaxation techniques, and biofeedback). |
| Standard Care Group | Active comparator | Procedure: Standard Care GroupParticipants will receive standard care, consisting of pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18-65 years.
- Diagnosed with Temporomandibular Disorders (TMD) based on DC/TMD Axis I and Axis II criteria.
- Presenting with symptoms such as jaw pain, limited jaw movement, or psychosocial distress (anxiety, depression).
- Willing and able to provide informed consent.
- Able to comply with the study protocol and attend all follow-up visits.
Key exclusion criteria (6 listed)
- Severe systemic diseases or other neurological conditions that could interfere with treatment or outcomes.
- History of psychiatric disorders unrelated to TMD, such as schizophrenia or bipolar d disorder.
- Pregnant or lactating women.
- Use of medications or treatments within the past month that could influence study outcomes (e.g., corticosteroids, strong analgesics).
- Individuals with severe dental or maxillofacial conditions requiring immediate surgical intervention.
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 |
|---|---|---|
| Behavioral Therapy GroupIncludes Cognitive Behavioral Therapy (CBT), relaxation techniques, and biofeedback. | Behavioural | Behavioral Therapy Group |
| Standard Care GroupIncludes pharmacological treatment (e.g., NSAIDs, muscle relaxants) and physical therapy interventions | Procedure or surgery | Standard Care Group |
Primary outcome
Pain Intensity
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Assesses changes in self-reported pain levels with scores ranging from 0 (no pain) to 10 (worst pain)levels (0 = no pain, 10 = worst pain)
Psychological Distress (Anxiety)
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Measures depression levels with a score based on the frequency and severity of symptoms.
Psychological Distress (Depression)
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Measures depression levels with a score based on the frequency and severity of symptoms.
4 secondary outcomes
Maximum Mouth Opening
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Jaw Range of Motion
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Pain-Related Disability
Time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up
Long-Term Symptom Relief
Time frame: 6-month follow-up
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 18 Apr 2025.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) from this study will not be shared with other researchers. This decision is based on the need to protect participant privacy and confidentiality, as well as the sensitive nature of the data collected, including psychological and health-related information. Although the study results will be shared in aggregated and anonymized formats through publications and presentations, no raw or identifiable participant data will be disclosed to external parties. This approach ensures compliance with ethical guidelines and data protection regulations.
Related trials for Temporomandibular Joint Disorders
Recruiting
Photobiomodulation for Management of Temporomandibular Disorder Pain
Pain Related to TMD
Recruiting
Effects of Vagus Nerve Stimulation on Temporomandibular Disorders.
TMD, Temporomandibular Disorders (TMDs)
Recruiting
Marine Lipids Ease Painful TMD
Temporomandibular Disorder (TMD)
Not yet recruiting
Comparing Dextrose Prolotherapy vs. Sodium Hyaluronic Acid Injections for Jaw Joint Internal Derangement
Temporomandibular Joint Internal Derangement, TMJ-ID
Recruiting
R01_Pilot Jaw Muscle Phenotypes
Chronic TMD Pain, Temporomandibular Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy Group in people with Temporomandibular Joint Disorders and Chronic Pain, run by King Khalid University at 1 site in Saudi Arabia.
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 6 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 18 Apr 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 Saudi Arabia. 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?
Pain Intensity (time frame: Baseline, 8 weeks post-treatment, and 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Apr 2025.