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NCT Number: NCT07412067

Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Post Graduate Institute of Dental Sciences, Rohtak

Rohtak, Haryana, 124001, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Guided Tissue Regeneration

Procedure

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

Primary outcomes

  1. 2D and 3D Radiographic Healing

    Time frame: 12 months

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Dr Jigyasa Duhan, MDS

CONTACT

[email protected]

+919896270449

Shweta Mittal, MDS

CONTACT

+919255596960

Sponsors and collaborators

Lead sponsor

Postgraduate Institute of Dental Sciences Rohtak

Other

Collaborators

  • Post Graduate Institute of Dental Sciences

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Feb 17, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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