Anterior Disc DisplacementNCT06651814
Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction
A study testing Supervised Exercise Group and Home Exercise Group in people with Anterior Disc Displacement, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
Trial summary
The aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Anterior Disc Displacement
- What is being tested?
- Supervised Exercise Group and Home Exercise Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 sitePakistan
- Study dates
- 20 Aug 2024to 21 Feb 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age: 18-70 years
- Both genders
- TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement
- Clicking sounds during jaw opening and closing
- Interincisor distance ≥ 5mm wider during mouth opening
- Clicking suppression with protruded mandible
Show all 9Show fewer
- Clicking presence in at least two of three repetitions
- NRS score ≥ 4 for TMJ clicking sound severity
- TMJ clicking sound frequency: once a week or more
Who cannot join
- Major psychiatric disorders
- Ongoing treatments related to symptoms
- Active rheumatologic disease
- Malignant disease
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Armed Forces Institute of Dentistry
Rawalpindi, Punjab Province, 46000
About this study
The aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction.
Read the detailed description
This study will help the clinical practitioner to choose better exercise option in patients with symptomatic disc displacement with reduction in order to avoid clicking sound.
- Conditions
- Anterior Disc Displacement
- Being tested
- Supervised Exercise Group, Home Exercise Group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Supervised Exercise GroupBehavioural
A supervised exercise program will consists of 10 sessions. The 1st exercise station will be a 5-minute warming up of the jaw with a heat lamp. The 2nd station will involve jaw opening-closing movements (TMJ rotation) with the mandible in a slightly protruded position for 6 minutes. The 3rd and 4th exercise stations will comprised of jaw opening and jaw protrusion, respectively, against resistance for 4 minutes each. Measurements will be done before the trial started and after 3 months.
Home Exercise GroupBehavioural
Patients will received a home regime of jaw exercises. They will be instructed to do two different trainings. The 1st type of exercise will be jaw opening and closing movements daily for 5 minutes after each meal with the mandible and the head of the TMJ in a slightly protruded position. This exercise should not produce any clicking sounds. The 2nd type of exercise will be isometric exercises; this entailed jaw opening and jaw protrusion against resistance with their hand for 10 seconds with 10 repetitions each daily. All the patients will receive a training brochure with photos of the exercises and detailed information on frequency and exercise time. The brochure will include a diary. After 6 weeks, the subject and the assistant will check the performance of the exercise and the diary
| Study group | Role | What they receive |
|---|---|---|
| Supervised Exercise Group | Experimental | Patients receive supervised exercise therapy from a qualified physical therapist or healthcare professional, with a set frequency and duration Receives: Behavioral: Supervised Exercise Group |
| Home Exercise Group | Active comparator | Patients receive written instructions and demonstrations for performing exercises at home, with recommended frequency and duration Receives: Behavioral: Home Exercise Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
clicking sounds frequency
Assessment of clicking sounds frequency before and after intervention.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2024
- Study start20 Aug 2024
- Primary completion21 Feb 2025
- Study completion21 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Disc DisplacementStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Armed Forces Institute of Dentistry, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Ayesha Younas, Armed Forces Institute of Dentistry, Pakistan
- Investigators
- Ayesha Younas, BDS, Principal investigator, Armed Forces Institute of Dentistry, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06651814
- Sponsor's protocol ID
- AYounas
- Status last verified
- Mar 2025
- First submitted
- 17 Oct 2024
- Last updated
- 4 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment Outcome of Supervised Exercise and Home Exercise in Patients with Symptomatic Disc Displacement with Reduction
- ClinicalTrials.gov ID
- NCT06651814
- Acronym / sponsor ID
- AYounas
- Conditions
- Anterior Disc Displacement
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Armed Forces Institute of Dentistry, PakistanUniversity, hospital or other
- Study start
- 20 Aug 2024 (actual)
- Primary completion
- 21 Feb 2025 (actual)
- Study completion
- 21 Feb 2025 (actual)
- First posted
- 22 Oct 2024 (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 aim of the study is to evaluate the treatment outcome of supervised exercise and home exercise in patients with symptomatic disc displacement with reduction.
Detailed description
This study will help the clinical practitioner to choose better exercise option in patients with symptomatic disc displacement with reduction in order to avoid clicking sound.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supervised Exercise Group | Experimental | Behavioral: Supervised Exercise GroupPatients receive supervised exercise therapy from a qualified physical therapist or healthcare professional, with a set frequency and duration |
| Home Exercise Group | Active comparator | Behavioral: Home Exercise GroupPatients receive written instructions and demonstrations for performing exercises at home, with recommended frequency and duration |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age: 18-70 years
- Both genders
- TMJ clicking sounds fulfilling RDC/TMD for symptomatic disc displacement
- NRS score ≥ 4 for TMJ clicking sound severity
- TMJ clicking sound frequency: once a week or more
Key exclusion criteria (4 listed)
- Major psychiatric disorders
- Ongoing treatments related to symptoms
- Active rheumatologic disease
- Malignant disease
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 |
|---|---|---|
| Supervised Exercise GroupA supervised exercise program will consists of 10 sessions. The 1st exercise station will be a 5-minute warming up of the jaw with a heat lamp. The 2nd station will involve jaw opening-closing movements (TMJ rotation) with the mandible in a slightly protruded position for 6 minutes. The 3rd and 4th exercise stations will comprised of jaw opening and jaw protrusion, respectively, against resistance for 4 minutes each. Measurements will be done before the trial started and after 3 months. | Behavioural | Supervised Exercise Group |
| Home Exercise GroupPatients will received a home regime of jaw exercises. They will be instructed to do two different trainings. The 1st type of exercise will be jaw opening and closing movements daily for 5 minutes after each meal with the mandible and the head of the TMJ in a slightly protruded position. This exercise should not produce any clicking sounds. The 2nd type of exercise will be isometric exercises; this entailed jaw opening and jaw protrusion against resistance with their hand for 10 seconds with 10 repetitions each daily. All the patients will receive a training brochure with photos of the exercises and detailed information on frequency and exercise time. The brochure will include a diary. After 6 weeks, the subject and the assistant will check the performance of the exercise and the diary | Behavioural | Home Exercise Group |
Primary outcome
clicking sounds frequency
Time frame: 3 months
Assessment of clicking sounds frequency before and after 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 4 Mar 2025.
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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.
Ayesha Younas, BDS principal investigator
Armed Forces Institute of Dentistry, Pakistan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Supervised Exercise Group and Home Exercise Group in people with Anterior Disc Displacement, run by Armed Forces Institute of Dentistry, Pakistan at 1 site in Pakistan.
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 9 inclusion and 4 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 4 Mar 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 Pakistan. 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?
clicking sounds frequency (time frame: 3 months). 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 4 Mar 2025.