Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation Using Partially Demineralized Dentin Block Versus Xenograft in the Esthetic Zone: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 26
- 试验地点
- 2
- 主要终点
- Change in radiographic horizontal ridge width
研究概览
简要总结
The aim of this study is to clinically and radiographically evaluate the dimensional changes of hard tissue after using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone.
The main question: In patients with unrestorable teeth, will the use of partially demineralized Dentin Block be more effective than Xenograft in preserving vertical and horizontal ridge dimensions?
After enrollment, a thorough preoperative assessment, including history taking, clinical, and radiographic examinations, will be conducted.
Initial therapy includes periodontal treatment (phase 1 therapy) followed by random assignment to one of two treatment groups: ridge preservation using Partially Demineralized Dentin Block or Xenograft.
Both groups will undergo atraumatic extraction.
For the test group, an autogenous partially demineralized dentin graft will be prepared, involving tooth cleaning, grinding, and partial demineralization with the Tooth Transformer device, followed by Leukocyte-Platelet Rich Fibrin (L-PRF) membrane and liquid fibrinogen preparation. The L-PRF membranes will be cut, mixed with dentin particles, and combined with liquid fibrinogen to form a compact graft. The block will be placed inside the socket and covered by an L-PRF membrane and secured with a cross-suture.
In the control group, Xenograft will be used, and the socket filled with deproteinized bovine bone mineral, covered with a collagen membrane, and secured with a cross-suture.
After a healing period of 6 months, at the time of implant placement, a biopsy will be taken using a trephine bur.
详细描述
Objective of the study: The aim of this study is to evaluate post extraction hard tissue changes following ridge preservation using Partially Demineralized Dentin Block versus Xenograft in the esthetic zone.
Research Procedure: Patients will be selected from the outpatient clinic of the Oral Medicine and Periodontology Department, Faculty of Dentistry, Cairo University.
General operative procedures: Patients who fulfill the inclusion criteria will be enrolled. The nature of the study will be explained to each patient, as well as the importance of compliance with pre- and post-operative instructions and follow-up visits.
Preoperative preparation: A thorough preoperative assessment of all patients will be carried out, including history taking, clinical examination, and radiographic examination.
History: Each patient will be interviewed to obtain a comprehensive history.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with non-restorable teeth and Type II extraction socket in the esthetic zone
- •Healthy patients with adequate oral hygiene (bleeding on probing ≤20%; Plaque index ≤20%).
- •Systemically healthy.
排除标准
- •Heavy smokers (more than 10 cigarettes per day or an electronic cigarette dose of >6 mg/ml of nicotine).
- •Patients reporting systemic conditions that may compromise healing or bone metabolism (eg: diabetes).
- •Patients with poor oral hygiene (bleeding on probing >20%; Plaque index >20%)
- •The presence of acute periapical infection.
- •The presence of severe periodontal destruction.
研究组 & 干预措施
Partially Demineralized Dentin Block
The Partially Demineralized Dentin Block will be prepared using the Tooth Transformer device to grind the extracted tooth and partially demineralize it. Leukocyte-Platelet Rich Fibrin (L-PRF) and liquid fibrinogen will then be added to create a block graft.
干预措施: Partially Demineralized Dentin Block (Biological)
Xenograft
The Xenograft procedure will involve filling the socket with deproteinized bovine bone mineral, followed by the placement of a collagen membrane to cover the socket
干预措施: Xenograft (Biological)
结局指标
主要结局
Change in radiographic horizontal ridge width
时间窗: at baseline and 6 months postoperatively
CBCT scans will be performed at baseline and 6 months postoperatively. Measurements will be taken at both time points using identical reference points and lines. To establish a reference, the most apical point of the extraction socket will be identified on the baseline image, and two reference lines will be drawn. The vertical reference line will be placed at the midpoint of the extraction socket, intersecting the apical reference point. Additionally, a horizontal reference line will be drawn perpendicular to the vertical line, passing through the apical reference point. The horizontal ridge width will be measured at three specific levels: 2 mm, 4 mm, and 6 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-2, HW-4, and HW-6, respectively.
次要结局
- Percentage of new vital bone formation and residual graft(after 6 months postoperatively)
- Implant Primary Stability(after 6 months postoperatively)
- Change in radiographic buccal and palatal ridge height(at baseline and 6 months postoperatively)
研究者
Danah Tayseer Al Ghothani
Principal Investigator
Cairo University