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临床试验/NCT07412067
NCT07412067尚未招募不适用

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

Postgraduate Institute of Dental Sciences Rohtak1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年4月1日最近更新:
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
50
试验地点
1
主要终点
2D and 3D Radiographic Healing

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

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

研究组 & 干预措施

Apicomarginal defects treated with allograft and membrane combination

Experimental

Apicomarginal defects treated with allograft and membrane combination

干预措施: Guided tissue regeneration (Procedure)

Apicomarginal defects treated with autograft and membrane combination

Active Comparator

Apicomarginal defects treated with autograft and membrane combination

干预措施: Guided tissue regeneration (Procedure)

结局指标

主要结局

2D and 3D Radiographic Healing

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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