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

NCT07048171 | Recruiting

• 1 other identifier: Mareesha
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

To determine the effect of allograft and iPRF with or without collagen membrane on healing of apicomarginal defects : A Randomized Controlled Trial

Conditions

Apicomarginal Defects

Outcome Measures

Primary Outcomes (1)

• Periapical healing assessment

  Periapical healing comparison in 2 groups with buccal bone regeneration and 2d healing and 3d healing outcome using Rud and Molven et al. (1987). \& modified PENN 3D criteria .

  Base line to 12 months

Secondary Outcomes (1)

• Quality of life assessment

  Base line to 12 months

Study Arms (2)

patients with apicomarginal defects receiving bone graft and iPRF with collagen membrane

EXPERIMENTAL

surgery performed using DFDBA bone graft and iPRF with collagen membrane

Procedure: Endodontic Micro-Surgery

patients with apicomarginal defects receiving bone graft and iPRF without collagen membrane

ACTIVE COMPARATOR

surgery performed using DFDBA bone graft and iPRF without collagen membrane

Procedure: Endodontic Micro-Surgery

Interventions

Endodontic Micro-Surgery PROCEDURE

Surgery performed using bone graft(DFDBA) and iPRF with collagen membrane in test group and bone graft and iPRF without collagen membrane in control group

patients with apicomarginal defects receiving bone graft and iPRF with collagen membrane; patients with apicomarginal defects receiving bone graft and iPRF without collagen membrane

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).
• Patients aged 18 years and above, presenting with chronic suppurative apical periodontitis in at least one tooth,
• Radiographic evidence of apical radiolucency with periodontal pocket depth exceeding 6 mm confined to buccal aspect of the root.
• Repeated abscess discharge despite satisfactory root canal treatment. 5.Patients with apicomarginal defects showing a denuded buccal bone plate
• Failed primary root canal treatment 7.Adequate final restoration with no clinical evidence of coronal leakage.

You may not qualify if:

• Clinical or radiographic evidence of root fracture.
• Resorptive processes involving more than apical third of the root.
• Chronic generalized periodontitis.
• Failed previous endodontic surgery or failed root canal re-treatment.
• Any systemic disease contraindicating oral surgery including uncontrolled diabetes and pregnancy, any condition effecting rate of healing like smoking.

Sponsors & Collaborators

• Postgraduate Institute of Dental Sciences Rohtak: lead

Study Sites (1)

PGIDS

Rohtak, Haryana, 124001, India

RECRUITING

Central Study Contacts

DR. Sanjay Tewari, MDS

CONTACT

09416259534; tewarisanjayrohtak@yahoo.com

Mareesha Mareesha, PG student

CONTACT

09728202108; mareeshasingh95@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 24, 2025
• First Posted: July 2, 2025
• Study Start: April 18, 2025
• Primary Completion: April 18, 2026
• Study Completion (Estimated): April 18, 2027
• Last Updated: July 2, 2025

Record last verified: 2025-06

Locations

IN (1)