Comparison Between Xenograft and Extended PRF as Jumping Gap Grafting Material Versus Natural Healing of the Socket Without Any Material.
Clinical and Digital Evaluation of Different Jumping Gap Grafting Materials Versus No Grafting Material in Immediate Lower Molar Implant Placement
研究概览
地位
条件
详细说明
Following atraumatic extraction and implant site preparation within the interradicular bone, the implant will be immediately inserted. A chairside customized healing abutment will then be fabricated to seal the extraction socket. According to group allocation, the jumping gap will be filled with xenograft, e-PRF, or left unfilled before placement of the customized healing abutment. Definitive prosthetic restoration will be delivered after three months of implant insertion.
Clinical Evaluation:
Implant stability will be assessed at implant placement and at 3 and 6 months using resonance frequency analysis with the Osstell device, with implant stability quotient (ISQ) values recorded.
Peri-implant soft-tissue health will be assessed using the modified sulcus bleeding index (mSBI) at 3 and 6 months intervals.
Digital Evaluation:
Peri-implant soft-tissue dimensional changes will be assessed using intraoral optical scans obtained preoperatively and at 1, 3, and 6 months. The resulting STL files will be superimposed using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
- Radiographic Evaluation:
CBCT examinations will be obtained preoperatively, immediately after implant placement, and at 6 months. Three-dimensional superimposition of baseline and follow-up DICOM datasets will be used to evaluate hard-tissue dimensional changes.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
-
Al Mansurah、埃及
- Faculty of Dentistry, Mansoura University
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-
参与标准
资格标准
适合学习的年龄
- 成人
接受健康志愿者
描述
Inclusion Criteria:
- Any partially dentate patients with non-restorable mandibular molar requiring dental extraction.
- Extraction sockets with intact bony walls and interradicular bone.
- Jumping gap more than 2mm.
Exclusion Criteria:
- Patients with any pathological lesion or aggressive periodontal disease at the planned surgical site impaired the immediate implant placement.
- Heavy smokers (≥ pack per day)
- Pregnancy.
- Patients with systemic diseases that absolutely contraindicate implant placement or para-functional habits (bruxism or clenching).
- Patients with poor oral hygiene or aggressive periodontal disease.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Ten immediate mandibular molar implant placement with xenograft filling materialof the jumping gap.
|
after tooth extraction and implant placement, xenograft particulates were placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
|
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实验性的：Ten immediate mandibular molar implant placement with e-PRF filling material of the jumping gap.
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after tooth extraction and implant placement, e-PRF was prepared from the patient's collected blood and placed to fill the jumping gap before sealing the socket with a chairside socket sealing abutment.
|
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无干预：Immediate mandibular molar implant placement without grafting material.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Linear and Volumetric Digital Evaluation of implant site
大体时间：preoperative, 1 month, 3 months and 6 months postoperative.
|
Peri-implant soft-tissue dimensional changes assessment using intraoral optical scans and resulting STL files superimposition using a best-fit alignment algorithm to evaluate dimensional changes in the peri-implant soft tissues.
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preoperative, 1 month, 3 months and 6 months postoperative.
|
|
Radiographic Evaluation of Implant Site Volumetric Change
大体时间：preoperatively, immediately after implant placement, and at 6 months
|
CBCT examinations obtained and three-dimensional superimposition of baseline and follow-up DICOM datasets used to evaluate hard-tissue dimensional changes.
|
preoperatively, immediately after implant placement, and at 6 months
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Implant Stability
大体时间：at implant placement, 3 months and 6 months postoperative.
|
Implant stability assessment using resonance frequency analysis with the Osstell device to record implant stability quotient (ISQ) values.
|
at implant placement, 3 months and 6 months postoperative.
|
|
Modified Sulcus Bleeding Index
大体时间：at 3 and 6 months postoperative.
|
Evaluation of peri-implant soft-tissue health using the modified sulcus bleeding index (mSBI).
|
at 3 and 6 months postoperative.
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- A01012024OS
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
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