Temporomandibular Joint Disc DisplacementNCT05532098
Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
A study testing Dry Needling and PRP in people with Temporomandibular Joint Disc Displacement, run by Postgraduate Institute of Dental Sciences Rohtak at 1 site in India.
Trial summary
Pain and trismus are of the prime concerns for the patients in case of Anterior disc displacement ADD of temporomandibular joint (TMJ). In the recent times, PRP has has produced promising results in management of TMDs. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Temporomandibular Joint Disc Displacement
- What is being tested?
- Dry Needling and PRP
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteIndia
- Study dates
- 4 Sep 2021to 15 Mar 2023
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 1. Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- 2. Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
Who cannot join
- 1. Patients with phobia to needles 2. Patients who have undergone previous treatment for anterior disc displacement in past 6 months 3. Patients with active infection at the site of injection 4. Patients on anticoagulant medication 5. Pregnancy/ Lactation 6. Patients with healing disorder or systemic disease where healing response is compromised 7. Patients with epilepsy/seizures 8. Patients with bleeding and clotting disorder 9. Patients with malignancy 10. Patients with uncontrolled para-functional habits
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
PGIDS
Rohtak, Haryana, 124001
Dr.Sanjay Tiwari, MDS, principalpgids@yahoo.in
About this study
Pain and trismus are of the prime concerns for the patients in case of Anterior disc displacement ADD of temporomandibular joint (TMJ). In the recent times, PRP has has produced promising results in management of TMDs. It has potential healing properties on new bone and cartilage through the recruitment, proliferation, migration, and differentiation of cells and its tissue remodelling, matrix production, and chondrogenic differentiation properties. It also increases the production of hyaluronic acid by synoviocytes. Needle injury also produces immediate analgesia without hypesthesia, mainly on the painful spot making it effective for the pain reduction and improved mouth opening. Similar effect of dry needling can also be expected in the joint space where it may induce a transient inflammatory cascade leading to healing of the damaged tissue.
So, the Present study is designed to evaluate the efficacy of PRP for the treatment of ADD of TMJ.
Read the detailed description
Study Design: Randomized clinical trial Study Duration: This study will be completed in 1 year 3 months (3 months for patient recruitment, 9 months for study including treatment and follow up and 3 months for data compilation).
Population: Patients suffering from Anterior Disc Displacement will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology.
Sample size: Sample size consists of 39 patients in each group. Methods: PRP will be performed in test group while dry needling will be performed in control group.
- Being tested
- Dry Needling, PRP
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dry NeedlingProcedure or surgery
Dry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space .
PRPProcedure or surgery
Patients with ADD are administered with 1ml of PRP into the retrodiscal tissue and the superior joint space. PRP will be prepared by method proposed by Okuda et al., 2003. Reinjection will be given after 2 weeks if required.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | Patients diagnosed with ADD under this group are subjected to Dry Needling Receives: Procedure: Dry Needling |
| Test group | Experimental | Patients diagnosed with ADD under this group are administered with 1ml of PRP solution . Receives: Procedure: PRP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Measured: 2 weeks
Pain intensity
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Measured: 4 weeks
Pain intensity
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Measured: 3 months
Pain intensity
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Measured: 6 months
Mouth opening and Functional movements
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Measured: 2 weeks
Mouth opening and Functional movements
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Measured: 4 weeks
Mouth opening and Functional movements
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Measured: 3 months
Mouth opening and Functional movements
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Measured: 6 months
Secondary outcomes (16)
Joint sounds
To evaluate the changes in joint sounds before and after the treatment (present or absent ).
Measured: 2 weeks
Joint sounds
To evaluate the changes in joint sounds before and after the treatment (present or absent ).
Measured: 4 weeks
Joint sounds
To evaluate the changes in joint sounds before and after the treatment (present or absent ).
Measured: 3 months
Joint sounds
To evaluate the changes in joint sounds before and after the treatment (present or absent ).
Measured: 6 months
Pain medication
To evaluate the need for pain medicine utilization (number of tablets).
Measured: 2 weeks
Pain medication
To evaluate the need for pain medicine utilization (number of tablets).
Measured: 4 weeks
Pain medication
To evaluate the need for pain medicine utilization (number of tablets).
Measured: 3 months
Pain medication
To evaluate the need for pain medicine utilization (number of tablets).
Measured: 6 months
Patient satisfaction
To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups
Measured: 2 weeks
Patient satisfaction
To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups
Measured: 4 weeks
Patient satisfaction
To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups
Measured: 3 months
Patient satisfaction
To evaluate patient satisfaction before and after treatment (Likerts scale) in both groups
Measured: 6 months
Sleep pattern
To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups
Measured: 2 weeks
Sleep pattern
To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups
Measured: 4 weeks
Sleep pattern
To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups
Measured: 3 months
Sleep pattern
To evaluate sleep pattern before and after treatment (Visual Analogue Scale score) in both groups
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 posted8 Sep 2022
- Study start4 Sep 2021
- Primary completion15 Feb 2023 (estimated)
- Study completion15 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Temporomandibular Joint Disc DisplacementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 78 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
- NCT05532098
- Sponsor's protocol ID
- SURIYA N OMR
- Status last verified
- Sep 2022
- First submitted
- 14 Aug 2021
- Last updated
- 8 Sep 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Efficacy of Platelet Rich Plasma and Dry Needling in Management of Anterior Disc Displacement of Temporomandibular Joint
- ClinicalTrials.gov ID
- NCT05532098
- Acronym / sponsor ID
- SURIYA N OMR
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (estimated)
- Lead sponsor
- Postgraduate Institute of Dental Sciences RohtakUniversity, hospital or other
- Study start
- 4 Sep 2021 (actual)
- Primary completion
- 15 Feb 2023 (estimated)
- Study completion
- 15 Mar 2023 (estimated)
- First posted
- 8 Sep 2022 (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 are of the prime concerns for the patients in case of Anterior disc displacement ADD of temporomandibular joint (TMJ). In the recent times, PRP has has produced promising results in management of TMDs. It has potential healing properties on new bone and cartilage through the recruitment, proliferation, migration, and differentiation of cells and its tissue remodelling, matrix production, and chondrogenic differentiation properties. It also increases the production of hyaluronic acid by synoviocytes. Needle injury also produces immediate analgesia without hypesthesia, mainly on the painful spot making it effective for the pain reduction and improved mouth opening. Similar effect of dry needling can also be expected in the joint space where it may induce a transient inflammatory cascade leading to healing of the damaged tissue.
So, the Present study is designed to evaluate the efficacy of PRP for the treatment of ADD of TMJ.
Detailed description
Study Design: Randomized clinical trial Study Duration: This study will be completed in 1 year 3 months (3 months for patient recruitment, 9 months for study including treatment and follow up and 3 months for data compilation).
Population: Patients suffering from Anterior Disc Displacement will be recruited in study from regular OPD of the Department of Oral Medicine and Radiology.
Sample size: Sample size consists of 39 patients in each group. Methods: PRP will be performed in test group while dry needling will be performed in control group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Procedure: Dry NeedlingPatients diagnosed with ADD under this group are subjected to Dry Needling |
| Test group | Experimental | Procedure: PRPPatients diagnosed with ADD under this group are administered with 1ml of PRP solution . |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 1. Patients diagnosed with Anterior disc displacement clinically according to TMD/RDC criteria (2013-14).
- 2. Patients diagnosed with Anterior disc displacement confirmed using Magnetic Resonance Imaging.
Key exclusion criteria (1 listed)
- 1. Patients with phobia to needles 2. Patients who have undergone previous treatment for anterior disc displacement in past 6 months 3. Patients with active infection at the site of injection 4. Patients on anticoagulant medication 5. Pregnancy/ Lactation 6. Patients with healing disorder or systemic disease where healing response is compromised 7. Patients with epilepsy/seizures 8. Patients with bleeding and clotting disorder 9. Patients with malignancy 10. Patients with uncontrolled para-functional habits
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 |
|---|---|---|
| Dry NeedlingDry Needling will be done for the patients with ADD of TMJ in the retrodiscal tissue and superior joint space . | Procedure or surgery | Control group |
| PRPPatients with ADD are administered with 1ml of PRP into the retrodiscal tissue and the superior joint space. PRP will be prepared by method proposed by Okuda et al., 2003. Reinjection will be given after 2 weeks if required. | Procedure or surgery | Test group |
Primary outcome
Pain intensity
Time frame: 2 weeks
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Pain intensity
Time frame: 4 weeks
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Pain intensity
Time frame: 3 months
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Pain intensity
Time frame: 6 months
To evaluate the intensity of pain before and after the treatment (Visual Analogue Scale score).
Mouth opening and Functional movements
Time frame: 2 weeks
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Mouth opening and Functional movements
Time frame: 4 weeks
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Mouth opening and Functional movements
Time frame: 3 months
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
Mouth opening and Functional movements
Time frame: 6 months
To evaluate the maximal mouth opening and functional movements before and after the treatment (millimetre).
16 secondary outcomes
Joint sounds
Time frame: 2 weeks
Joint sounds
Time frame: 4 weeks
Joint sounds
Time frame: 3 months
Joint sounds
Time frame: 6 months
Pain medication
Time frame: 2 weeks
Pain medication
Time frame: 4 weeks
Pain medication
Time frame: 3 months
Pain medication
Time frame: 6 months
Patient satisfaction
Time frame: 2 weeks
Patient satisfaction
Time frame: 4 weeks
Patient satisfaction
Time frame: 3 months
Patient satisfaction
Time frame: 6 months
Sleep pattern
Time frame: 2 weeks
Sleep pattern
Time frame: 4 weeks
Sleep pattern
Time frame: 3 months
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 8 Sep 2022.
- Individual participant dataSharing planned: No
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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 study testing Dry Needling and PRP in people with Temporomandibular Joint Disc Displacement, 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 1 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 8 Sep 2022. 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.
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 Dr.Ambika Gupta, MDS (9315903300, drambika79@rediffmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (time frame: 2 weeks). The study lists 8 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 8 Sep 2022.