Anterior Disk Displacement TMJPhase 4NCT04319406
Comparative Efficacy of Prolotherapy and Dry Needling in Management of ADD
A Phase 4 study testing Prolotherapy and Dry needling in people with Anterior Disk Displacement TMJ, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Pain and trismus caused by Anterior disc displacement ADD of temporomandibular joint (TMJ) are one of the prime concerns for the patients. In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Anterior Disk Displacement TMJ
- What is being tested?
- Prolotherapy and Dry needling
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteIndia
- Study dates
- 5 Jan 2020to 5 Sep 2020
- Phase
- Phase 4
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
Who cannot join
- Patients with phobia to needles
- Patients who have undergone previous treatment for anterior disc displacement in past 6 months
- Patients who are allergic to the components of prolotherapy solution
- Patients with active infection at the site of injection
- Patients on anticoagulant medication
- Patients with healing disorder or systemic disease where healing response is compromised
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- Patients with epilepsy/seizures
- Patients with bleeding and clotting disorder
- Patients with malignancy
- Patients with uncontrolled para-functional habits
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Post Graduate Institute of Dental Sciences
Rohtak, Haryana, 124001
Jatin Lonyal, BDS, 9958838085, dr.jatinlonyal@gmail.com
About this study
Official title: Comparative Efficacy of Prolotherapy and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
Pain and trismus caused by Anterior disc displacement ADD of temporomandibular joint (TMJ) are one of the prime concerns for the patients. In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In Inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing cascade which leads to repair of the joint structures.
Thus, the Present study is designed to evaluate the efficacy of dextrose prolotherapy for the treatment of ADD in TMJ.
Read the detailed description
Temporomandibular joint (TMJ) is a ginglymodiarthroidal joint located bilaterally in the preauricular region of head. It is formed by the confluence of multiple skeletal, muscular, ligament and discal components which work in harmony with each other. Articular disc functions as a non-ossified bone, allowing complex movements, making it a compound joint.
Any loss in synchronization or harmony of the components of TMJ leads to temporomandibular disorders. Okeson broadly classified temporomandibular disorders into Masticatory muscle disorders, Temporomandibular joint disorders. Disc displacements are categorized under Temporomandibular joint disorders of the condyle-disc complex.
Normally articular disc is positioned over the cranial portion of mandibular condyle at 12 o'clock position when teeth are in occlusion. Abnormal position of disc with respect to mandibular condyle or mandibular fossa is known as disc displacement. Most common displacement of disc is in antero-medial direction.1 Disc displacements are of two types: disc displacement with reduction and disc displacement without reduction. Anterior disc displacement (ADD) associated with pain require treatment.
Established treatment modalities include use of Non steroidal anti inflammatory drugs (NSAIDS), Anterior repositioning appliances, Physiotherapy, Psychological therapy, Arthroscopy, Arthroplasty and Arthrocentesis. Newer treatment modalities that are under research are platelet rich plasma therapy, prolotherapy and stem cell therapy.
Prolotherapy, which is also known as regenerative injection therapy, and growth factor stimulation injection therapy. It can be used to strengthen and repair chronic ligament, joint, capsule, and tendinous injuries by stimulating proliferation of collagen at the fibro osseous junctions to promote soft tissue repair and relative pain.
Prolotherapy has recently emerged as a technique with low cost and minimal side effects for management of Temporomandibular joint disorders. Prolotherapy is of 3 types - Growth factor injection prolotherapy, growth factor stimulation prolotherapy and Inflammatory prolotherapy.2 In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing process. Dextrose is most common and ideal proliferant used because it is a normal constituent of blood chemistry, water soluble and injected safely into multiple areas.3
The concentration of dextrose solution does not affect the results till the solution is hypertonic i.e above 10%. However, it is still not clear whether it is irritant effect of dextrose or mechanical injury caused by needle that produce the desired result .2 Dry needling can also induce a low grade inflammatory process in the joint. Dry needling has been proven to be equally beneficial in temporomandibular myofascial pain that involves inserting a needle into trigger points to inactivate them. Stimulation of these trigger points by needling alone, produce an analgesic effect by altering somatosensory thresholds .4 So, the present study has been designed to compare the efficacy of dextrose solution injection compared to dry needling in ADD of TMJ.
- Conditions
- Anterior Disk Displacement TMJ
- Being tested
- Prolotherapy, Dry needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProlotherapyProcedure or surgery
Test group will be administered 12.5% Dextrose mainly into superior joint space according to symptoms of patient at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.
Dry needlingProcedure or surgery
Only dry needling will be performed at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required.
| Study group | Role | What they receive |
|---|---|---|
| PROLOTHERAPY | Experimental | Prolotherapy will be performed with 12.5 % Dextrose into superior joint space of involved TMJ Receives: Procedure: Prolotherapy |
| DRY NEEDLING | Active comparator | Dry needling will be performed into superior joint space of involved TMJ Receives: Procedure: Dry needling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of pain
VAS Score
Measured: 6 months
Maximal mouth opening
Manual measurement in mm
Measured: 6 months
Secondary outcomes (6)
Range of Right and left Lateral excursion movements
Manual measurement in mm
Measured: 6 months
Range of Protrusive movement
Manual measurement in mm
Measured: 6 months
Joint sounds
Presence or absent
Measured: 6 months
Pain medicine utilization
No. of tablets consumed
Measured: 6 months
Patient satisfaction
Likert scale
Measured: 6 months
Assessment of Sleep pattern
VAS score
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2020
- Study start5 Jan 2020
- Primary completion5 Aug 2020 (estimated)
- Study completion5 Sep 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anterior Disk Displacement TMJStudies of the same condition, open and under way.
- More trials run by Postgraduate Institute of Dental Sciences RohtakThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Postgraduate Institute of Dental Sciences Rohtak
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04319406
- Sponsor's protocol ID
- Jatin13
- Status last verified
- Mar 2020
- First submitted
- 26 Feb 2020
- Last updated
- 24 Mar 2020
- 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 24 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Prolotherapy and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT04319406
- Acronym / sponsor ID
- Jatin13
- Conditions
- Anterior Disk Displacement TMJ
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 5 Jan 2020 (actual)
- Primary completion
- 5 Aug 2020 (estimated)
- Study completion
- 5 Sep 2020 (estimated)
- First posted
- 24 Mar 2020 (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.
Pain and trismus caused by Anterior disc displacement ADD of temporomandibular joint (TMJ) are one of the prime concerns for the patients. In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In Inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing cascade which leads to repair of the joint structures.
Thus, the Present study is designed to evaluate the efficacy of dextrose prolotherapy for the treatment of ADD in TMJ.
Detailed description
Temporomandibular joint (TMJ) is a ginglymodiarthroidal joint located bilaterally in the preauricular region of head. It is formed by the confluence of multiple skeletal, muscular, ligament and discal components which work in harmony with each other. Articular disc functions as a non-ossified bone, allowing complex movements, making it a compound joint.
Any loss in synchronization or harmony of the components of TMJ leads to temporomandibular disorders. Okeson broadly classified temporomandibular disorders into Masticatory muscle disorders, Temporomandibular joint disorders. Disc displacements are categorized under Temporomandibular joint disorders of the condyle-disc complex.
Normally articular disc is positioned over the cranial portion of mandibular condyle at 12 o'clock position when teeth are in occlusion. Abnormal position of disc with respect to mandibular condyle or mandibular fossa is known as disc displacement. Most common displacement of disc is in antero-medial direction.1 Disc displacements are of two types: disc displacement with reduction and disc displacement without reduction. Anterior disc displacement (ADD) associated with pain require treatment.
Established treatment modalities include use of Non steroidal anti inflammatory drugs (NSAIDS), Anterior repositioning appliances, Physiotherapy, Psychological therapy, Arthroscopy, Arthroplasty and Arthrocentesis. Newer treatment modalities that are under research are platelet rich plasma therapy, prolotherapy and stem cell therapy.
Prolotherapy, which is also known as regenerative injection therapy, and growth factor stimulation injection therapy. It can be used to strengthen and repair chronic ligament, joint, capsule, and tendinous injuries by stimulating proliferation of collagen at the fibro osseous junctions to promote soft tissue repair and relative pain.
Prolotherapy has recently emerged as a technique with low cost and minimal side effects for management of Temporomandibular joint disorders. Prolotherapy is of 3 types - Growth factor injection prolotherapy, growth factor stimulation prolotherapy and Inflammatory prolotherapy.2 In the recent times, Inflammatory Prolotherapy has been studied extensively and has produced promising results. In inflammatory prolotherapy low grade inflammation is induced physiologically by injection of an irritant solution that initiates healing process. Dextrose is most common and ideal proliferant used because it is a normal constituent of blood chemistry, water soluble and injected safely into multiple areas.3
The concentration of dextrose solution does not affect the results till the solution is hypertonic i.e above 10%. However, it is still not clear whether it is irritant effect of dextrose or mechanical injury caused by needle that produce the desired result .2 Dry needling can also induce a low grade inflammatory process in the joint. Dry needling has been proven to be equally beneficial in temporomandibular myofascial pain that involves inserting a needle into trigger points to inactivate them. Stimulation of these trigger points by needling alone, produce an analgesic effect by altering somatosensory thresholds .4 So, the present study has been designed to compare the efficacy of dextrose solution injection compared to dry needling in ADD of TMJ.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PROLOTHERAPY | Experimental | Procedure: ProlotherapyProlotherapy will be performed with 12.5 % Dextrose into superior joint space of involved TMJ |
| DRY NEEDLING | Active comparator | Procedure: Dry needlingDry needling will be performed into superior joint space of involved TMJ |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
Key exclusion criteria (10 listed)
- Patients with phobia to needles
- Patients who have undergone previous treatment for anterior disc displacement in past 6 months
- Patients who are allergic to the components of prolotherapy solution
- Patients with active infection at the site of injection
- Patients on anticoagulant medication
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 |
|---|---|---|
| ProlotherapyTest group will be administered 12.5% Dextrose mainly into superior joint space according to symptoms of patient at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required. | Procedure or surgery | PROLOTHERAPY |
| Dry needlingOnly dry needling will be performed at baseline (0 week) and at biweekly intervals at 2 and 4 weeks i.e. a total of 3 injections. A 4th injection will be given at 6 weeks if required. | Procedure or surgery | DRY NEEDLING |
Primary outcome
Intensity of pain
Time frame: 6 months
VAS Score
Maximal mouth opening
Time frame: 6 months
Manual measurement in mm
6 secondary outcomes
Range of Right and left Lateral excursion movements
Time frame: 6 months
Range of Protrusive movement
Time frame: 6 months
Joint sounds
Time frame: 6 months
Pain medicine utilization
Time frame: 6 months
Patient satisfaction
Time frame: 6 months
Assessment of Sleep pattern
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Prolotherapy and Dry needling in people with Anterior Disk Displacement TMJ, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
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 10 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: status not confirmed, as of the sponsor's last update on 24 Mar 2020. 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 India. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanjay Tewari, MDS (01262283876, principalpgidsrohtak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensity of pain (time frame: 6 months). 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?
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 24 Mar 2020.