Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation In The Esthetic Zone Using Partially Demineralized Autogenous Dentine Graft Versus Xenograft: A Randomized Controlled Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 1
- 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 establish if there are clinical, radio-graphical and histomorphometrical differences between using Partially Demineralized Dentin graft versus Xenograft in the esthetic zone. as a clinical application in alveolar bone regeneration procedures related to implant dentistry, including socket preservation, alveolar ridge augmentation, after tooth extraction in the esthetic zone. After extraction of non-restorable teeth in the esthetic zone, will ridge preservation with application of partially demineralized autogenous dentin graft produce less hard tissue changes compared to xenograft?
The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. Flapless and atraumatic tooth extraction will be initiated, Then the sockets will be carefully packed with the allocated graft material that are shaped to match the individual size and contours of each socket. Once the grafts are properly adapted to the sockets, they will be covered with collagen membrane. The membrane will be shaped to extend 2-3 mm beyond the margins of the extraction socket and positioned just beneath the marginal mucosa. To ensure its stability, a cross-suture will be performed, securing the membrane in place.
Intervention group: The socket will be filled with partially demineralized autogenous dentin graft Control group: The socket will be filled with xenograft . For both groups, All the subjects will be evaluated at pre-surgical, baseline and 6 months post surgical months for clinical parameters and baseline( immediate post-surgical and 6 months post-surgical . Outcomes: Change in radiographic horizontal ridge width at 1mm below the most coronal aspect of the crest , Change in radiographic horizontal ridge width at 3 and 5mm below the most coronal aspect of the crest,Change in radiographic buccal ridge height , Change in radiographic buccal ridge height ,Change in radiographic Palatal ridge height,Percentage of new vital bone formation,Percentage of residual bone graft,Implant Primary Stability.
Detailed Description: This study aims to evaluate clinical, radiographic and histomorphometrica
详细描述
The study aims to radiographically evaluate the dimentionsal changes of hard tissue after application of partailly deminerlized dentin graft verus xenograft in the esthatic zone .
Research Procedure in brief:
The study is to be conducted in the Oral Medicine and Periodontology department, Faculty of Dentistry- Cairo University, Egypt.Patients are to be selected from the outpatient clinic of the department of Oral Medicine and Periodontology, clinic of the department of Oral surgery and clinic of the department of Endodontics -Cairo University. The initial therapy consists of periodontal treatment (phase I therapy) including supragingival scaling, subgingival debridement if needed, adjustment of faulty restoration and polishing. The mechanical plaque control instructions for each patient include brushing and interdental cleaning techniques. surgical interventions: Atraumatic extraction.The patient will rinse their mouth with 0.12% Chlorhexidine Administration of 4% articaine hydrochloride with 1:100,000 epinephrine will be as local anesthetic agent.Flapless and atraumatic tooth extraction will be initiated, using 15C blade intrasulcular incision will be performed.A periotome will be utilized to sever the periodontal ligament (PDL) fibers, followed by extraction witha straight elevator and extraction forceps.
In the test group:
The autogenous partially demineralized dentin graft will be prepared as follows:
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
- Triple (Participant, Investigator, 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
- 是
入选标准
- •Patients with non-restorable teeth and Type II extraction socket in the esthetic zone indicated for extraction for periodontal, carious or traumatic reasons.
- •Healthy patients with adequate oral hygiene (bleeding on probing ≤20%; Plaque index ≤20%).
- •Adult patients above 18 years old.
- •Patients accept 6-months follow-up period and provide an informed consent.
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.
结局指标
主要结局
Change in radiographic horizontal ridge width
时间窗: after 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: 1 mm, 3 mm, and 5 mm below the most coronal aspect of the crest. These measurements will be denoted as HW-1, HW-3, and HW-5, respectively.
次要结局
- Implant Primary Stability(after 6 months postoperatively)
- Percentage of new vital bone formation and residual graft(after 6 months postoperatively)
- Change in radiographic buccal and palatal ridge height:(after 6 months postoperatively.)
研究者
Riham Ahmad Alshiek Hani Alkurdee
principle investigator Riham Ahmad Master degree student, periodontology department, faculty of dentistry, Cairo University
Cairo University