TMJ Disc DisorderPhase 2/3NCT06859034
Therapeutic Effect of Proliferative Therapy (Prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients With Anterior Disc Displacement With Reduction: A Randomized Clinical Trial .
A Phase 2/3 study testing injection of dextrose 10% in retrodiscal tissues and injection of dextrose 25% in retrodiscal tissues in people with TMJ Disc Disorder, run by Cairo University.
Trial summary
prolotherapy is an injection-based treatment method used to alleviate pain, particularly musculoskeletal pain associated with chronic ligament and tendon injuries. The process involves the injection of a solution, typically containing dextrose (a sugar), saline, or other irritants, into the affected tissues. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- TMJ Disc Disorder
- What is being tested?
- injection of dextrose 10% in retrodiscal tissues and injection of dextrose 25% in retrodiscal tissues
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- 3 Mar 2025to Oct 2025
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients should have one or more signs and symptoms of these
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening .
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck
Who cannot join
- The clinical or radiographic signs of disc displacement without reduction .
- A history of allergic reactions to any components of the injectable solution.
- Blood dyscrasias and systemtic diseases .
- Previous surgery of the affected joint.
- Infection in pre-auricular area
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
nourhan moustafa nourhan moustafa abd el rahman hasan abo el ela, Bachelor's degree contact
About this study
prolotherapy is an injection-based treatment method used to alleviate pain, particularly musculoskeletal pain associated with chronic ligament and tendon injuries. The process involves the injection of a solution, typically containing dextrose (a sugar), saline, or other irritants, into the affected tissues. Prolotherapy is believed to stimulate healing by causing a mild inflammatory response that promotes the regeneration of ligaments, tendons, and other connective tissues. This review explores the existing literature on the therapeutic effects of prolotherapy for pain management.
Read the detailed description
Anterior disc displacement with reduction (ADDR) is a common temporomandibular joint (TMJ) disorder, characterized by the displacement of the articular disc in front of the condyle during mouth opening, which then reduces upon closing. This condition often results in pain, restricted jaw movement, and clicking sounds. Conservative treatments, including physical therapy, splint therapy, and pharmacological interventions, are commonly used, but these may not always yield long-term results. Recent studies have explored the role of prolotherapy, particularly the use of dextrose injections, in treating TMJ disorders, including ADDR. Among the variations in prolotherapy, the concentration of dextrose solution-commonly 10% and 25%-is often debated for its potential effectiveness in promoting healing and pain relief. Prolotherapy is often compared to other injection-based treatments, such as corticosteroid injections and platelet-rich plasma (PRP) therapy. A study by Chou et al. (2017) found that prolotherapy was more effective than corticosteroid injections for the management of chronic tendon and ligament pain, with longer-lasting effects and fewer side effects. Similarly, prolotherapy was found to be as effective as PRP for certain conditions, such as chronic tendinopathies, although PRP may offer additional benefits in tissue regeneration due to its higher concentration of growth factors (Gosens et al., 2020).
6
The literature supports prolotherapy as a promising treatment for various chronic pain conditions, especially those involving tendons, ligaments, and joints. Evidence from clinical trials suggests that prolotherapy is effective in reducing pain, improving function, and promoting tissue regeneration in conditions like chronic low back pain, knee osteoarthritis, and soft tissue injuries. However, despite the promising results, the overall quality of evidence remains moderate, and further large-scale, high-quality studies are needed to fully establish its efficacy and long-term outcomes. Prolotherapy is generally safe, but like any invasive treatment, it carries a risk of adverse effects, albeit minimal.
As prolotherapy continues to gain recognition in pain management, its potential as an adjunct or alternative to traditional therapies warrants further investigation.
- Conditions
- TMJ Disc Disorder
- Being tested
- injection of dextrose 10% in retrodiscal tissues, injection of dextrose 25% in retrodiscal tissues
- Keywords
- retrodiscal tissues
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
injection of dextrose 10% in retrodiscal tissuesDrug
group 1 will recieve 10% dextrose in retrodiscal tissues
injection of dextrose 25% in retrodiscal tissuesDrug
group 2 will recieve 25% dextrose
| Study group | Role | What they receive |
|---|---|---|
| injection of dextrose 10% in retrodiscal tissues | Active comparator | GROUP 1 will recieve 10% dextrose Receives: Drug: injection of dextrose 10% in retrodiscal tissues |
| injection of dextrose 25% in retrodiscal tissues | Experimental | group 2 will recieve 25% dextrose Receives: Drug: injection of dextrose 25% in retrodiscal tissues |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pain Severity Measured by Numerical Rating Scale (NRS)
Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score with standard deviation (SD)
Measured: Measured at baseline, 1 month, 3 months, and 6 months after injections.
Secondary outcomes (2)
Change in Maximal Interincisal Opening (MIO) Measured in Millimeters
Maximal interincisal opening (MIO) will be measured using a digital caliper, with values recorded in millimeters (mm). The mean change in MIO from baseline will be reported . Data Aggregation: Mean change in MIO (mm) with standard deviation (SD).
Measured: Measured at baseline, 1 month, 3 months, and 6 months after injections
Presence or Absence of Joint Clicking (Binary Outcome)
Joint clicking will be assessed as a binary outcome (Yes/No) based on clinical examination and patient-reported symptoms. The percentage of participants with joint clicking at each time point will be reported.
Data Aggregation: Percentage of participants with joint clicking at each time point
Measured: Measured at baseline, 1 month, 3 months, and 6 months after injections
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start3 Mar 2025 (estimated)
- Primary completion3 Sep 2025 (estimated)
- Study completionOct 2025 (estimated)
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 TMJ Disc DisorderStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nourhan Moustafa, Cairo University
- Investigators
- nadia galal Professor, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06859034
- Sponsor's protocol ID
- prolotherapy injection in tmj
- Status last verified
- Mar 2025
- First submitted
- 22 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Haggag MA, Al-Belasy FA, Said Ahmed WM. Dextrose prolotherapy for pain and dysfunction of the TMJ reducible disc displacement: A randomized, double-blind clinical study. J Craniomaxillofac Surg. 2022 May;50(5):426-431. doi: 10.1016/j.jcms.2022.02.009. Epub 2022 Mar 8.
PubMed 35501215Park JS, Ku JK, Kim YK, Yun PY. Efficacy of dextrose prolotherapy on temporomandibular disorder: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Oct 31;50(5):259-264. doi: 10.5125/jkaoms.2024.50.5.259.
PubMed 39482101
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Therapeutic Effect of Proliferative Therapy (Prolotherapy) on Pain Using Injectable Hypertonic Dextrose 25% Versus Injectable Dextrose 10% in Retrodiscal Tissues in Patients With Anterior Disc Displacement With Reduction: A Randomized Clinical Trial .
- ClinicalTrials.gov ID
- NCT06859034
- Acronym / sponsor ID
- prolotherapy injection in tmj
- Conditions
- TMJ Disc Disorder
- Keywords
- retrodiscal tissues
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 3 Mar 2025 (estimated)
- Primary completion
- 3 Sep 2025 (estimated)
- Study completion
- Oct 2025 (estimated)
- First posted
- 5 Mar 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.
prolotherapy is an injection-based treatment method used to alleviate pain, particularly musculoskeletal pain associated with chronic ligament and tendon injuries. The process involves the injection of a solution, typically containing dextrose (a sugar), saline, or other irritants, into the affected tissues. Prolotherapy is believed to stimulate healing by causing a mild inflammatory response that promotes the regeneration of ligaments, tendons, and other connective tissues. This review explores the existing literature on the therapeutic effects of prolotherapy for pain management.
Detailed description
Anterior disc displacement with reduction (ADDR) is a common temporomandibular joint (TMJ) disorder, characterized by the displacement of the articular disc in front of the condyle during mouth opening, which then reduces upon closing. This condition often results in pain, restricted jaw movement, and clicking sounds. Conservative treatments, including physical therapy, splint therapy, and pharmacological interventions, are commonly used, but these may not always yield long-term results. Recent studies have explored the role of prolotherapy, particularly the use of dextrose injections, in treating TMJ disorders, including ADDR. Among the variations in prolotherapy, the concentration of dextrose solution-commonly 10% and 25%-is often debated for its potential effectiveness in promoting healing and pain relief. Prolotherapy is often compared to other injection-based treatments, such as corticosteroid injections and platelet-rich plasma (PRP) therapy. A study by Chou et al. (2017) found that prolotherapy was more effective than corticosteroid injections for the management of chronic tendon and ligament pain, with longer-lasting effects and fewer side effects. Similarly, prolotherapy was found to be as effective as PRP for certain conditions, such as chronic tendinopathies, although PRP may offer additional benefits in tissue regeneration due to its higher concentration of growth factors (Gosens et al., 2020).
6
The literature supports prolotherapy as a promising treatment for various chronic pain conditions, especially those involving tendons, ligaments, and joints. Evidence from clinical trials suggests that prolotherapy is effective in reducing pain, improving function, and promoting tissue regeneration in conditions like chronic low back pain, knee osteoarthritis, and soft tissue injuries. However, despite the promising results, the overall quality of evidence remains moderate, and further large-scale, high-quality studies are needed to fully establish its efficacy and long-term outcomes. Prolotherapy is generally safe, but like any invasive treatment, it carries a risk of adverse effects, albeit minimal.
As prolotherapy continues to gain recognition in pain management, its potential as an adjunct or alternative to traditional therapies warrants further investigation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| injection of dextrose 10% in retrodiscal tissues | Active comparator | Drug: injection of dextrose 10% in retrodiscal tissuesGROUP 1 will recieve 10% dextrose |
| injection of dextrose 25% in retrodiscal tissues | Experimental | Drug: injection of dextrose 25% in retrodiscal tissuesgroup 2 will recieve 25% dextrose |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Patients should have one or more signs and symptoms of these
- Symptoms: Patients who report typical symptoms of TMJ dysfunction, such as pain, discomfort, or clicking sounds in the joint, especially when opening or closing the mouth.
- Mouth Opening: Limited range of motion or difficulty with full mouth opening .
- Clicking: Audible clicking.
- Pain: Pain or tenderness around the TMJ, often radiating to the ear, temple, or neck
Key exclusion criteria (5 listed)
- The clinical or radiographic signs of disc displacement without reduction .
- A history of allergic reactions to any components of the injectable solution.
- Blood dyscrasias and systemtic diseases .
- Previous surgery of the affected joint.
- Infection in pre-auricular area
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 |
|---|---|---|
| injection of dextrose 10% in retrodiscal tissuesgroup 1 will recieve 10% dextrose in retrodiscal tissues | Drug | injection of dextrose 10% in retrodiscal tissues |
| injection of dextrose 25% in retrodiscal tissuesgroup 2 will recieve 25% dextrose | Drug | injection of dextrose 25% in retrodiscal tissues |
Primary outcome
Change in Pain Severity Measured by Numerical Rating Scale (NRS)
Time frame: Measured at baseline, 1 month, 3 months, and 6 months after injections.
Pain severity will be assessed using the Numerical Rating Scale (NRS) (0-10), where 0 = no pain and 10 = severe pain. Participants will report their pain levels at each time point. The mean change in NRS scores from baseline will be calculated and analyzed . Data Aggregation: Mean change in NRS score with standard deviation (SD)
2 secondary outcomes
Change in Maximal Interincisal Opening (MIO) Measured in Millimeters
Time frame: Measured at baseline, 1 month, 3 months, and 6 months after injections
Presence or Absence of Joint Clicking (Binary Outcome)
Time frame: Measured at baseline, 1 month, 3 months, and 6 months after injections
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Results publication: PubMed 35501215Haggag MA, Al-Belasy FA, Said Ahmed WM. Dextrose prolotherapy for pain and dysfunction of the TMJ reducible disc displacement: A randomized, double-blind clinical study. J Craniomaxillofac Surg. 2022 May;50(5):426-431. doi: 10.1016/j.jcms.2022.02.009. Epub 2022 Mar 8.
- Results publication: PubMed 39482101Park JS, Ku JK, Kim YK, Yun PY. Efficacy of dextrose prolotherapy on temporomandibular disorder: a retrospective study. J Korean Assoc Oral Maxillofac Surg. 2024 Oct 31;50(5):259-264. doi: 10.5125/jkaoms.2024.50.5.259.
- Individual participant dataSharing planned: Undecided
Related trials for TMJ Disc Disorder
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Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
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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.
nourhan moustafa nourhan moustafa abd el rahman hasan abo el ela, Bachelor's degree contact
nadia galal Professor, phd study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing injection of dextrose 10% in retrodiscal tissues and injection of dextrose 25% in retrodiscal tissues in people with TMJ Disc Disorder, run by Cairo University.
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 5 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: opening soon, as of the sponsor's last update on 5 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact nourhan moustafa nourhan moustafa abd el rahman hasan abo el ela, Bachelor's degree (01118233832, nourhan.hasan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Severity Measured by Numerical Rating Scale (NRS) (time frame: Measured at baseline, 1 month, 3 months, and 6 months after injections.). 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 NCT06859034, 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 5 Mar 2025.