Allograft plus iPRF with or without a collagen membrane for healing apicomarginal defects

TO DETERMINE THE EFFECT OF ALLOGRAFT AND iPRF WITH OR WITHOUT COLLAGEN MEMBRANE ON HEALING OF APICOMARGINAL DEFECTS

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

• Phase: NA
• Study type: Interventional
• Enrollment: 50 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Postgraduate Institute of Dental Sciences Rohtak (other)
• Locations: 1 site (Rohtak, Haryana)
• Trial ID: NCT07048171 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Rohtak, Haryana

• PGIDS — Rohtak, Haryana, India (RECRUITING)

Study contacts

• Study coordinator: DR. Sanjay Tewari, MDS

Conditions: Apicomarginal Defects