Comparative Analysis of Healing Outcomes Between Two Bone Graft Materials in Socket Preservation Procedure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- Change in buccolingual ridge width
研究概览
简要总结
Socket preservation procedures after tooth extraction have been designed and implemented to maintain the volume of the bone and gingival tissues, which can decrease following the extraction of the teeth. In this clinical trial we will compare clinically and histologically the effectiveness of two distinct bovine bone graft materials; an allograft and a xenograft, in alveolar ridge preservation procedures following tooth extraction .
详细描述
Patients who seek socket preservation procedures will be identified and recruited from the out clinic of College of Dentistry. Inclusion criteria will be: systemically healthy, non-smoking patients aged 21-50 years, with no bone metabolism affecting medications, good oral hygiene (full-mouth plaque score <20%), and willingness to participate. Exclusion criteria included stage III/IV periodontitis, active periodontal lesions, acute infection, severely resorbed sockets (buccal bone height <5 mm), smoking >10 cigarettes/day, and pregnancy.
Indications for extraction include caries, failed endodontic treatment, unrestorable teeth, and tooth fracture. All patients underwent full periodontal examination and initial therapy (oral hygiene instructions, scaling, and root planing) at least 4 weeks before surgery. Preoperative CBCT scans will be analyzed for baseline conditions. Reference stents will be fabricated and used to standardize bone dimensional measurements.
Sample size estimation was based on detecting a mean dimensional change in ridge width following 2-3 months of healing. With SD = 10%, α = 0.05, and power = 80%, a minimum of 9 sockets per group (18 total) was deemed adequate.
Surgical Protocol All surgical procedures will be performed under local anesthesia (2% lidocaine with 1:100,000 epinephrine). A sulcular incision will be made with a 15c blade, and atraumatic extraction will be achieved using periotomes, tooth separation, and forceps while preserving the buccal plate. Following thorough socket debridement, the buccolingual ridge width will be measured using a periodontal probe and customized stent.
Patients will be randomly allocated into one of two treatment groups:
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
- 21 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Systemically healthy individuals
- •Non-smokers
- •Age between 21 and 50 years
- •Indicated for tooth extraction and socket preservation
- •Good oral hygiene (full-mouth plaque score <20%)
- •Willingness to participate and provide informed consent
排除标准
- •• Stage III or IV periodontitis
- •Active periodontal or periapical infection
- •Severely resorbed sockets (buccal bone height <5 mm)
- •Smoking more than 10 cigarettes per day
- •Pregnancy
- •Systemic conditions or medications affecting bone metabolism
研究组 & 干预措施
Allograft Group
Extraction sockets grafted with cortico-cancellous particulate allograft and covered with a collagen membrane.
干预措施: Socket Preservation with Graft Material Allograft (Procedure)
Xenograft Group
Extraction sockets grafted with xenograft material and covered with a collagen membrane.
干预措施: Socket Preservation with Graft Material Allograft (Procedure)
结局指标
主要结局
Change in buccolingual ridge width
时间窗: Baseline to 2-3 months
Difference in ridge width measured clinically and radiographically between baseline and 2-3 months post-extraction
次要结局
- Histomorphometric outcomes(2-3 months)
研究者
Haitham Sakr
Principle investigator
Pharos University in Alexandria