Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-04-06 @ 7:27 AM
Study NCT ID:
NCT07412067
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-17
First Post:
2026-02-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'interventionBrowseModule': {'meshes': [{'id': 'D048091', 'term': 'Guided Tissue Regeneration'}], 'ancestors': [{'id': 'D019651', 'term': 'Plastic Surgery Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-04-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-09', 'studyFirstSubmitDate': '2026-02-09', 'studyFirstSubmitQcDate': '2026-02-09', 'lastUpdatePostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '2D and 3D Radiographic Healing', 'timeFrame': '12 months', 'description': '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.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['apicomarginal, endodontic surgery, guided tissue regeneration'], 'conditions': ['Apicomarginal Defects']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.\n\nThis 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.\n\nFollow-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients 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.\n\nNegative response to pulp vitality tests.\n\nExclusion Criteria:\n\nPresence of root fractures or perforations. Patients with compromised systemic health (ASA II or above). Smokers.'}, 'identificationModule': {'nctId': 'NCT07412067', 'briefTitle': 'Healing of Apicomarginal Defects Using Autograft or Allograft With Collagen Membrane', 'organization': {'class': 'OTHER', 'fullName': 'Postgraduate Institute of Dental Sciences Rohtak'}, 'officialTitle': 'Comparative Evaluation of Autograft and Allograft With Collagen Membrane in the Healing of Apicomarginal Defects: A Parallel-Arm Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'Dr Jigyasa Duhan'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Apicomarginal defects treated with allograft and membrane combination', 'description': 'Apicomarginal defects treated with allograft and membrane combination', 'interventionNames': ['Procedure: Guided tissue regeneration']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Apicomarginal defects treated with autograft and membrane combination', 'description': 'Apicomarginal defects treated with autograft and membrane combination', 'interventionNames': ['Procedure: Guided tissue regeneration']}], 'interventions': [{'name': 'Guided tissue regeneration', 'type': 'PROCEDURE', 'description': '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.\n\nAutograft + Collagen Membrane Group and Allograft + Collagen Membrane Group', 'armGroupLabels': ['Apicomarginal defects treated with allograft and membrane combination', 'Apicomarginal defects treated with autograft and membrane combination']}]}, 'contactsLocationsModule': {'locations': [{'zip': '124001', 'city': 'Rohtak', 'state': 'Haryana', 'country': 'India', 'facility': 'Post Graduate Institute of Dental Sciences, Rohtak', 'geoPoint': {'lat': 28.89447, 'lon': 76.58917}}], 'centralContacts': [{'name': 'Dr Jigyasa Duhan, MDS', 'role': 'CONTACT', 'email': 'prashitiduhan@rediffmail.com', 'phone': '+919896270449'}, {'name': 'Shweta Mittal, MDS', 'role': 'CONTACT', 'phone': '+919255596960'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Postgraduate Institute of Dental Sciences Rohtak', 'class': 'OTHER'}, 'collaborators': [{'name': 'Post Graduate Institute of Dental Sciences', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}