Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane

Comparative Evaluation of Autograft and Allograft With Collagen Membrane in the Healing of Apicomarginal Defects: A Parallel-Arm Randomized Clinical Trial

Apicomarginal defects, which connect apical and marginal bone loss, are difficult to manage surgically due to their limited regenerative potential. Guided tissue regeneration using grafts and collagen membranes may improve outcomes, but the comparative effectiveness of autografts and allografts in these defects is not well established. This randomized clinical trial at PGIDS Rohtak will evaluate 36 patients undergoing endodontic microsurgery, assigning them to either autograft or allograft combined with a bioresorbable collagen membrane. Clinical and CBCT-based radiographic healing will be monitored over 12 months. The study aims to determine whether allografts can achieve bone regeneration comparable to autografts, offering a less invasive option for treating apicomarginal defects.

Study Overview

• Status: Not yet recruiting
• Conditions: Apicomarginal Defects
• Intervention / Treatment: Procedure: Guided tissue regeneration

Detailed Description

Apicomarginal defects represent a challenging clinical scenario in endodontic surgery because they involve a continuous loss of both apical and marginal bone, which significantly reduces the chances of predictable regeneration. Conventional surgical approaches often yield limited success, prompting interest in guided tissue regeneration strategies that combine bone grafts with collagen membranes to enhance healing. Autografts remain the gold standard due to their inherent osteogenic potential, but their use is restricted by donor site morbidity, limited quantity, and increased operative time. Allografts provide a readily available and minimally invasive alternative, yet their performance in complex defects such as apicomarginal lesions has not been adequately compared to autografts.

This randomized clinical trial will be conducted at PGIDS Rohtak and will enroll 36 patients diagnosed with apicomarginal defects requiring endodontic microsurgery. Participants will be randomly allocated to one of two treatment groups: autograft with a bioresorbable collagen membrane or allograft with the same membrane configuration. Standardized microsurgical protocols will be followed for defect debridement, graft placement, and membrane adaptation. Postoperative evaluation will include clinical parameters such as periodontal attachment levels, probing depths, and symptom resolution, along with radiographic assessment using CBCT to quantify three-dimensional bone regeneration.

Follow-up examinations will be performed over a 12-month period to assess healing progression and compare outcomes between groups. The primary outcome measure will be volumetric bone fill evaluated through CBCT imaging, with secondary outcomes including clinical stability and the absence of disease recurrence. By directly comparing autografts and allografts under controlled conditions, this study aims to clarify whether allografts can provide equivalent regenerative outcomes, potentially offering clinicians a less invasive and more accessible option for managing apicomarginal defects in endodontic practice.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Dr Jigyasa Duhan, MDS; Phone Number: +919896270449; Email: prashitiduhan@rediffmail.com
• Study Contact Backup: Name: Shweta Mittal, MDS; Phone Number: +919255596960

Study Locations

• India
  • Haryana
    • Rohtak, Haryana, India, 124001
      • Post Graduate Institute Of Dental Sciences, Rohtak

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Patients aged ≥18 years. Presence of chronic suppurative apical periodontitis with an apicomarginal defect and deep periodontal pocket, suggesting endodontic-periodontal communication up to the apex.

Negative response to pulp vitality tests.

Exclusion Criteria:

Presence of root fractures or perforations. Patients with compromised systemic health (ASA II or above). Smokers.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Apicomarginal defects treated with allograft and membrane combination	Procedure: Guided tissue regeneration; All participants will undergo standardized endodontic microsurgery to manage apicomarginal defects. After flap reflection, defect debridement, root-end preparation, and retrograde filling, patients will be randomly assigned to one of two groups. Autograft + Collagen Membrane Group and Allograft + Collagen Membrane Group
Active Comparator: Apicomarginal defects treated with autograft and membrane combination	Procedure: Guided tissue regeneration; All participants will undergo standardized endodontic microsurgery to manage apicomarginal defects. After flap reflection, defect debridement, root-end preparation, and retrograde filling, patients will be randomly assigned to one of two groups. Autograft + Collagen Membrane Group and Allograft + Collagen Membrane Group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
2D and 3D Radiographic Healing	Volumetric bone fill in the apicomarginal defect, assessed using standardized CBCT imaging at baseline and 12 months. Bone regeneration will be quantified through CBCT-based volumetric analysis to compare healing between the autograft and allograft groups.	12 months

Collaborators and Investigators

• Sponsor: Postgraduate Institute of Dental Sciences Rohtak
• Collaborators: Post Graduate Institute of Dental Sciences

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2026
• Primary Completion (Estimated): May 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: February 9, 2026
• First Submitted That Met QC Criteria: February 9, 2026
• First Posted (Actual): February 17, 2026

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 9, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: apicomarginal, endodontic surgery, guided tissue regeneration
• Additional Relevant MeSH Terms: Surgical Procedures, Operative; Plastic Surgery Procedures; Guided Tissue Regeneration
• Other Study ID Numbers: Dr Jigyasa Duhan

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No