Evaluation of Post Extraction Hard Tissue Alteration Following Ridge Preservation in the Esthetic Zone Using Allogeneic Dentin Matrix Versus Demineralized Freeze-Dried Bone Allograft: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Change in Ridge width over 6 months
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 Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) 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.Will ridge preservation using Allogeneic Dentin Matrix be more effective than Demineralized Freeze-Dried Bone Allograft in managing the post extraction hard tissue alterations?
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. alginate impression will be taken to fabricate an acrylic stent to be used as reference for measurements of width of ridge clinically.
Flapless and atraumatic tooth extraction will be initiated, Then the socket will be filled either with Allogeneic Dentin Matrix or Demineralized freeze-dried bone allograft (DFDBA) up to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. criss-cross horizontal mattress suturing technique
Intervention group: The socket will be filled with Allogeneic Dentin Matrix Control group: The socket will be filled with Demineralized freeze-dried bone allograft (DFDBA).
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 ridge width clinically after 6 months, Change in the radiographic buccal vertical bone level, Change in the radiographic palatal vertical bone level,Change in the radiographic horizontal bone level,Percentage of new vital bone formation,Percentage of residual bone graft and Implant Primary Stability.
详细描述
This study aims to evaluate clinical, radiographic and histomorphometrical differences between using Allogenic Demineralized Dentin matrix versus Demineralized Freeze-Dried Bone Allograft (DFDBA) in alveolar ridge preservation after tooth extraction in the esthetic 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.
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
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients between the age of 20-
- •Single rooted, non-restorable or hopeless tooth with adjacent teeth.
- •Extraction socket with no more than 50% buccal bone loss
- •Patients accept 6-months follow-up period (cooperative patients).
- •Patients provide an informed consent.
排除标准
- •Patients with uncontrolled systemic disease.
- •Patient with severe para-functional habits.
- •Patients with poor maintenance of oral hygiene.
- •Pregnancy.
- •Patients taking any medications that could compromise healing.
研究组 & 干预措施
Allogenic Demineralized Dentin Matrix
Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Allogeneic Dentin Matrix (that has been prepared before) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered.
干预措施: Demineralized Dentin Matrix (Biological)
Demineralized Freeze-Dried Bone Allograft
Following atraumatic tooth extraction, curettes will be used to remove granulation tissues, and the socket will be irrigated with sterile normal saline.Then the socket will be filled with Demineralized freeze-dried bone allograft (DFDBA) to the crestal level of then bone followed by placement of a collagen membrane to cover the socket. Suturing technique will be a criss-cross horizontal mattress to ensure that most of the grafting material is covered.
干预措施: Demineralized freeze-dried bone allograft (DFDBA) (Biological)
结局指标
主要结局
Change in Ridge width over 6 months
时间窗: after 6 months postoperatively
Before surgical intervention, baseline and 6-month postoperative examination will be conducted. Before surgical procedure ridge width will be measured using caliper, a resin acrylic stent will be placed measurements of 3mm and 5mm from gingival margin will be marked and measures the ridge width through it, this will be repeated after extraction (baseline) and 6 months postoperative.
次要结局
- Change in the radiographic vertical bone level(after 6 months postoperatively)
- Change in the radiographic horizontal bone level(after 6 months postoperatively)
- Implant Primary Stability(after 6 months postoperatively)
- Percentage of new vital bone formation and residual graft(after 6 months postoperatively)
研究者
Fatima Mubarak Saleem Bin Nuhaid
Principal Investigator Fatima Mubarak Master Degree student, Periodontology department, Faculty of Dentistry, Cairo University
Cairo University