NCT07412067

Brief Summary

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.

Trial Health

63
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
7mo left

Started Apr 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress15%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

February 9, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

February 17, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Expected
Last Updated

February 17, 2026

Status Verified

February 1, 2026

Enrollment Period

1 month

First QC Date

February 9, 2026

Last Update Submit

February 9, 2026

Conditions

Apicomarginal Defects

Keywords

apicomarginal, endodontic surgery, guided tissue regeneration

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Apicomarginal defects treated with allograft and membrane combination

EXPERIMENTAL

Apicomarginal defects treated with allograft and membrane combination

Procedure: Guided tissue regeneration

Apicomarginal defects treated with autograft and membrane combination

ACTIVE COMPARATOR

Apicomarginal defects treated with autograft and membrane combination

Procedure: Guided tissue regeneration

Interventions

Guided tissue regenerationPROCEDURE

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

Apicomarginal defects treated with allograft and membrane combinationApicomarginal defects treated with autograft and membrane combination

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Post Graduate Institute of Dental Sciences, Rohtak

Rohtak, Haryana, 124001, India

Location

MeSH Terms

Interventions

Guided Tissue Regeneration

Intervention Hierarchy (Ancestors)

Plastic Surgery ProceduresSurgical Procedures, Operative

Central Study Contacts

Dr Jigyasa Duhan, MDS

CONTACT

+919896270449prashitiduhan@rediffmail.com

Shweta Mittal, MDS

CONTACT

+919255596960

Study Design

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

Study Record Dates

First Submitted

February 9, 2026

First Posted

February 17, 2026

Study Start

April 1, 2026

Primary Completion

May 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

February 17, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will not share

Locations

IN(1)