Calcium Gluconate-Activated PRP vs. Non-Activated PRP for ADD with Reduction
Official title: Calcium Gluconate Activated Versus Non-Activated Platelet Rich Plasma in Anterior Disc Displacement With Reduction of the Temporomandibular Joint: Randomized Clinical Trial.
Run by Cairo University · NCT07855887 · Data updated 2026-11-12
This trial tests whether activating PRP with calcium gluconate before a retrodiscal injection helps reduce TMJ pain and improve mouth opening in adults with anterior disc displacement with reduction.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 20 (estimated) |
| Sponsor | Cairo University Academic / other |
| Locations | 1 site (Cairo) |
| Status | Recruiting |
| Started | July 25, 2026 |
| Main results expected | October 25, 2026 |
| Study ends | November 2026 |
| Registry record updated | October 2, 2026 |
| Trial ID | NCT07855887 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18-65 with MRI-confirmed ADDWR and moderate pain who have failed at least 2 conservative therapies over 3 months.
✕Probably not a fit
Patients with contraindications to MRI, active TMJ infection or malignancy, pregnancy, coagulopathy, recent TMJ surgery or injections, or those not meeting diagnostic criteria may not benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults with ADDWR will be randomized to receive either calcium gluconate-activated PRP or non-activated PRP injected retrodiscaly. The study aims to see if the activated preparation yields better symptom relief and functional recovery, measured by changes in pain scores and the normal maximum mouth opening range. Outcomes will reflect changes over a defined follow-up period, with MRI-confirmed ADDWR diagnosis guiding inclusion. The insertion site targets the retrodiscal area to address disc instability without surgery. The trial will help determine if a chemically enhanced biologic treatment offers a meaningful clinical advantage.
Why it matters
Potential benefit: If activated PRP proves superior, patients could experience greater pain relief and improved jaw function with a non-surgical option.
How similar studies have gone: Prior laboratory data show higher growth factor release with activation, but clinical benefit in TMJ ADDWR remains to be proven.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults aged 18-65 years. * Clinical and MRI diagnosis of ADDWR per DCTMD criteria. * Baseline VAS pain score 4-10. * Failure of at least 2 conservative treatments (splint therapy, physiotherapy, NSAIDs) for 3 months. * Written informed consent. Exclusion Criteria: * • Systemic inflammatory arthritis (Rheumatoid arthritis, etc.). * Recent TMJ surgery or intra-articular injection within the last 6 months. * Pregnancy or lactation. * Active TMJ infection or malignancy. * Coagulopathy or anticoagulant therapy. * Contraindications to MRI (e.g., pacemaker).
Where it's running
-
Cairo University
Cairo, Egypt Recruiting
Study contacts
- Study coordinator: Mohamed A. Osama, BDS
- Email: mohamed.madkour@dentistry.cu.edu.eg
- Phone: 01013127607
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.