Allograft plus iPRF with or without a collagen membrane for healing apicomarginal defects
Official title: TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS
Run by Postgraduate Institute of Dental Sciences Rohtak · NCT07048171 · Data updated 2026-11-12
This trial will test whether adding a collagen membrane to an allograft and injectable platelet-rich fibrin (iPRF) helps adults with apicomarginal defects heal better after endodontic microsurgery.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 50 (estimated) |
| Sponsor | Postgraduate Institute of Dental Sciences Rohtak Academic / other |
| Locations | 1 site (Rohtak, Haryana) |
| Status | Recruiting |
| Started | April 18, 2025 |
| Main results expected | April 18, 2026 |
| Study ends | April 18, 2027 |
| Registry record updated | July 2, 2025 |
| Trial ID | NCT07048171 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18 years) with chronic suppurative apical periodontitis, a radiographic apical radiolucency, a buccal periodontal pocket >6 mm with a denuded buccal bone plate, ASA I–II, and failed prior root canal treatment are the ideal candidates.
✕Probably not a fit
Patients with root fractures, extensive root resorption beyond the apical third, chronic generalized periodontitis, prior failed endodontic surgery, or systemic contraindications to oral surgery are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This randomized controlled trial compares endodontic microsurgery using an allograft combined with iPRF with versus without a collagen membrane for apicomarginal defects. Eligible adults undergo root-end surgery and are allocated to one of the two adjunctive treatment arms. Outcomes include three-dimensional radiographic bone healing and patient-reported quality of life over scheduled follow-up visits. The study aims to determine if the membrane improves space maintenance and prevents epithelial down-growth to enhance regeneration.
Why it matters
Potential benefit: If successful, the approach could improve bone regeneration and help preserve the affected tooth, reducing symptoms and improving oral quality of life.
How similar studies have gone: About a dozen human studies and a few animal studies have tested membranes, grafts, or platelet concentrates with mixed results, but the specific comparison of allograft plus iPRF with versus without a collagen membrane is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with no general medical contraindications for oral surgical procedures (ASA-I and ASA-II according to the classification of the American Society of Anesthesiologist's). 2. Patients aged 18 years and above, presenting with chronic suppurative apical periodontitis in at least one tooth, 3. Radiographic evidence of apical radiolucency with periodontal pocket depth exceeding 6 mm confined to buccal aspect of the root. 4. Repeated abscess discharge despite satisfactory root canal treatment. 5.Patients with apicomarginal defects showing a denuded buccal bone plate 6.Failed primary root canal treatment 7.Adequate final restoration with no clinical evidence of coronal leakage. Exclusion Criteria: 1. Clinical or radiographic evidence of root fracture. 2. Resorptive processes involving more than apical third of the root. 3. Chronic generalized periodontitis. 4. Failed previous endodontic surgery or failed root canal re-treatment. 5. Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy, any condition effecting rate of healing like smoking.
Where it's running
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Pgids
Rohtak, Haryana, India Recruiting
Study contacts
- Study coordinator: DR. Sanjay Tewari, MDS
- Email: tewarisanjayrohtak@yahoo.com
- Phone: 09416259534
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.