Assessment of Labial Plate Thickness After Immediate Implant Placement in Type II Extraction Sockets Using Two Different Xenografts in the Esthetic Zone: a Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 26
- 试验地点
- 1
- 主要终点
- Labial Bone Plate Thickness Change
研究概览
简要总结
This randomized clinical trial aims to evaluate labial bone plate changes following immediate implant placement in Type II extraction sockets using two different xenograft materials and de-epithelialized free gingival graft in the esthetic zone . Patients requiring extraction and immediate implant placement will be randomly allocated into two groups according to the xenograft material used for defect grafting. Clinical and radiographic outcomes will be assessed to determine dimensional bone changes and implant success
详细描述
Immediate implant placement in the esthetic zone has become a predictable treatment modality aiming to reduce treatment time while preserving alveolar bone and soft tissue architecture. However, dimensional alterations of the labial bone plate remain a clinical concern, particularly in Type II extraction sockets.
The present randomized controlled clinical trial will compare the effect of two different xenograft materials and de-epithelialized free gingival graft used for defect grafting during immediate implant placement. Eligible patients indicated for tooth extraction and immediate implant placement will be randomly assigned into two parallel groups based on the grafting material used.
Clinical evaluation and standardized radiographic assessment using CBCT will be performed to measure labial plate thickness changes, peri-implant bone stability, and implant success outcomes over a defined follow-up period. The findings of this study aim to provide clinical evidence regarding the most effective xenograft material for preserving peri-implant hard tissue contours in the esthetic zone
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
- Double (Participant, Outcomes Assessor)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with one or more non-restorable teeth or remaining roots without signs of acute infection in the maxillary anterior region.
- •Type II extraction sockets.
- •Sufficient bone (>3 mm) apically and palatally to allow for proper implant positioning with sufficient primary stability (≥ 30 N cm).
- •Good compliance.
排除标准
- •Teeth with current acute periapical infection.
- •Medically compromised patients.
- •Heavy smokers (smoking of more than 10 cigarettes per day ).
- •Alcohol or drug abuse.
- •Patients undergoing chemotherapy and radiotherapy.
- •Poor oral hygiene.
- •Vulnerable groups (pregnant females and decision- impaired individual).
研究组 & 干预措施
Medpark S1 xenograft
Patients undergoing immediate implant placement in Type II extraction sockets with defect grafting using Medpark S1 xenograft .
干预措施: Immediate Implant Placement with Medpark S1 xenograft (Procedure)
bio-Oss xenograft
Patients undergoing immediate implant placement in Type II extraction sockets with defect grafting using bio-Oss xenograft.
干预措施: Immediate Implant Placement with bio-Oss xenograft (Procedure)
结局指标
主要结局
Labial Bone Plate Thickness Change
时间窗: 6 months post-implant placement
Dimensional changes of the labial alveolar bone plate will be measured using standardized CBCT images to assess the effectiveness of the two xenograft materials in preserving bone contour
次要结局
- Peri-implant mucosal level (PML)(6 months post-implant placement)
研究者
Basma Gamal Mohamed Ahmed
postgraduate researcher
Alexandria University