Effect of Ascorbic Acid-Loaded I-PRF With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation (AA-IPRF-PDDG)
Effect of Ascorbic Acid-Loaded Injectable Platelet-Rich Fibrin Combined With Partially Demineralized Dentin Graft on Alveolar Ridge Preservation: A Randomized Controlled Clinical Trial
The goal of this clinical trial is to find out which treatment best preserves the jawbone after tooth extraction in adults planning to receive a dental implant later.
The study will investigate whether adding vitamin C to a mixture of tooth particles and a material prepared from the participant's own blood helps preserve the jawbone and improve bone healing.
The main questions it aims to answer are
- Does adding vitamin C help preserve the width of the jawbone after tooth extraction?
- Does it improve new bone formation compared with the other treatments?
Researchers will compare three treatments to determine whether adding a blood-based material, with or without vitamin C, improves bone preservation.
- The first group will receive small particles prepared from their own extracted tooth.
- The second group will receive tooth particles mixed with a healing material prepared from their own blood.
- The third group will receive tooth particles mixed with the same blood-based material containing vitamin C.
Participants will undergo tooth extraction and receive one of these treatments. They will attend follow-up visits during the healing period.
Researchers will:
- Examine the treated area during follow-up visits.
- Take three-dimensional dental scans before treatment and four months later to measure changes in jawbone width and height.
- Collect a small bone sample during dental implant placement to examine new bone formation and healing.
The study will help determine whether adding vitamin C to the blood-based material provides additional benefits for preserving the jawbone before dental implant placement.
研究概览
地位
条件
详细说明
This study evaluates approaches to preserve the alveolar ridge following tooth extraction before delayed dental implant placement.
The study uses a partially demineralized dentin graft prepared from the participant's extracted tooth as the grafting material. It also investigates whether combining this graft with injectable platelet-rich fibrin (I-PRF), with or without added ascorbic acid (vitamin C), may influence bone healing and ridge preservation.
The rationale for using dentin is based on its potential as an autologous graft material. I-PRF provides an autologous blood-derived component. The addition of vitamin C is being investigated as a possible way to influence the healing response.
The study will assess changes in alveolar ridge dimensions and examine bone tissue collected during implant placement. Histological and histomorphometric analysis will help characterize new bone formation, residual graft material, and connective tissue within the healing site.
The findings may provide information about the role of vitamin C-enriched I-PRF when combined with autogenous dentin grafts for alveolar ridge preservation.
研究类型
注册 (估计的)
阶段
- 不适用
联系人和位置
学习联系方式
- 姓名：Mahmoud Ebrahim El-Saadawy, BDS
- 电话号码：+201000559354
- 邮箱：mahmoudelsaadawy061293@gmail.com
研究联系人备份
- 姓名：Mahmoud Ebrahim EL-Saadawy, BDS
- 电话号码：+201007258261
- 邮箱：mahmoudelsaadawy1993@gmail.com
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- Patients aged 18-60 years. ⁴⁷
- ASA Type I medically healthy patients with no significant medical history. ⁴⁷
- Non-restorable teeth indicated for extraction followed by delayed implant placement. ⁴⁸
- Patients eligible for immediate implant placement but facing factors that prevent implant placement at the time of extraction. ⁴⁸
- Patients requiring alveolar ridge preservation before planned dental implant placement.
- Presence of ST IB sockets after extraction. ⁴²-⁴⁴
- periodontally healthy adjacent teeth. ⁴⁸
- Adequate oral hygiene plaque index ≤15% and willingness to comply with the study protocol and follow-up visits. ⁴⁷
- Cooperative patients willing to comply with the 4-month follow-up period. ⁴⁷
- Ability to understand and sign the informed consent form. ⁴⁷
Exclusion Criteria:
- Uncontrolled systemic diseases affecting bone healing (e.g., uncontrolled diabetes mellitus).
- History of radiotherapy or chemotherapy involving the head and neck region.
- Current use of medications known to influence bone metabolism (e.g., bisphosphonates, denosumab, long-term corticosteroids).
- Smokers or tobacco users.
- Pregnancy or lactation.
- Acute uncontrolled infection extraction site.
- Patients with poor oral hygiene or untreated active periodontal disease.
- Psychiatric patients, or those with a learning disability, or those unable to give consent
- Patients unable or unwilling to attend follow-up visits.
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：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
有源比较器：Partially Demineralized Dentin Graft Alone
Participants will undergo alveolar ridge preservation following atraumatic tooth extraction using an autogenous partially demineralized dentin graft (PDDG) prepared from the extracted tooth. The graft will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. No injectable platelet-rich fibrin (I-PRF) or ascorbic acid will be added. |
Alveolar ridge preservation following atraumatic tooth extraction using an autogenous partially demineralized dentin graft (PDDG) prepared from the extracted tooth. The graft will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. No injectable platelet-rich fibrin (I-PRF) or ascorbic acid will be added. |
|
实验性的：Partially Demineralized Dentin Graft Combined with I-PRF
Participants will undergo alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) prepared from the participant's peripheral blood. The resulting mixture, referred to as Sticky Dentin, will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
Alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) prepared from the participant's peripheral blood. The resulting sticky dentin mixture will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
|
实验性的：Ascorbic Acid-Loaded I-PRF Combined with PDDG
Participants will undergo alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) containing ascorbic acid. The resulting mixture, referred to as AA-Sticky Dentin, will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
Alveolar ridge preservation using an autogenous partially demineralized dentin graft (PDDG) mixed with injectable platelet-rich fibrin (I-PRF) containing ascorbic acid. The resulting AA-Sticky Dentin mixture will be placed into the extraction socket, covered with an absorbable gelatin sponge, and secured with sutures. |
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 |
|---|---|---|
|
Change in Radiographic Horizontal Alveolar Ridge Width
大体时间：Baseline (before alveolar ridge preservation) to 4 months postoperatively.
|
The change in horizontal alveolar ridge width will be assessed using cone-beam computed tomography (CBCT) scans obtained at baseline before alveolar ridge preservation and 4 months postoperatively. Measurements will be performed at the extraction site using standardized anatomical reference points and consistent measurement procedures. The change in ridge width from baseline to 4 months will be compared among the three study groups. |
Baseline (before alveolar ridge preservation) to 4 months postoperatively.
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Histomorphometric Analysis of Core Bone Biopsy Specimens
大体时间：4 months after alveolar ridge preservation, during implant osteotomy. 4 months after alveolar ridge preservation, during implant osteotomy.
|
Histomorphometric analysis will be performed on core bone biopsy specimens collected from the alveolar ridge preservation sites during implant osteotomy 4 months postoperatively. The analysis will assess the percentages of newly formed bone, mature bone, and residual dentin graft particles in the specimens, and the results will be compared among the three study groups. |
4 months after alveolar ridge preservation, during implant osteotomy. 4 months after alveolar ridge preservation, during implant osteotomy.
|
合作者和调查者
调查人员
- 学习椅：Mohamed Sherif EL-Mofty, Professor、Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
- 研究主任：Shaimaa Hamdy Abd El-Azeem、: Department of Oral Medicine, Diagnosis and Periodontology, Faculty of Dentistry, Nahda University Beni-Suef, Egypt.
出版物和有用的链接
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研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
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
关键字
其他相关的 MeSH 术语
其他研究编号
- 00D-9-26-8
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
IPD 计划说明
Individual participant data will not be shared with other researchers. Only aggregated study results may be disseminated through scientific publications, while participant confidentiality and data privacy will be maintained in accordance with institutional ethical requirements.
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研究美国 FDA 监管的设备产品
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