Ridge Preservation Using Collagen Sponge Alone or Combined with Xenograft: a Clinical and Histological Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological
研究概览
简要总结
24 patients had a treatment plan for extraction of non restorable single rooted maxillary tooth and will be subjected to one of three groups after tooth extraction Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge alone and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
详细描述
- Surgical Phase:
- Local infiltration anesthesia will be first administered to all patients in this study.
- Teeth will be extracted, using a flapless approach a traumatically as much as possible.
- Atraumatic extraction will start with dissection of periodontal ligaments in crestal part using 15C blades mounted over a round-handed blade to facilitate rotation without lacerating the soft tissue
- Then teeth will be luxated using micro-elevators and the final delivery movement will be done using forceps.
- Sockets will be thoroughly debrided using a curette, especially in case with periapical lesions, to ensure complete removal of granulation tissue.
- Assessment of sockets walls integrity will be done visually and using a UNC-15 periodontal probe. All patients will be allocated into one of the three study groups. Group (I): including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket, till crestal bone level and socket sealing will be done with a new layer of collagen sponge(superficial collagen layer) and criss-cross suture to stabilize the graft in place.
Group (II): including 8 patients, preservation of extraction sockets will be done with collagen sponge and criss-cross suture. Group (III): control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss-cross suture.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Prevention
- 盲法
- Single (Participant)
盲法说明
The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program
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 a single rooted maxillary tooth that had a treatment plan of extraction as; endodontic complication, root fracture, trauma, or advanced carious lesions.
- •Teeth with or without periapical lesions not affecting buccal wall integrity.
- •Patients age (18 - 60) years old.
- •Patients with clinical periodontal health on an intact periodontium and adequate volume that allow for implant placement after follow-up period.
- •Pristine extraction socket (type I socket).
排除标准
- •Patients with any systemic condition that may affect surgical and healing process.
- •Patients with active acute infection related to teeth of interest.
- •Pregnant females.
- •History of malignancy or radiotherapy for malignancy in the past 5 years.
- •History of active bone metabolic disease.
- •Patients taking or were taking medications that may affect bone turnover such as bisphosphonates.
- •Patients with buccal bone thickness less than 1 mm that necessitate regeneration and flap elevation. 7
- •Smoker patients who reported tobacco use in the past 5 years.
- •The design of this clinical trial will be randomized double blind technique; the randomization of the patients will be performed through a computer program.
研究组 & 干预措施
Group I
including 8 patients, preservation of extraction sockets will be done with combination of collagen sponge (deep collagen layer) and xenograft will be placed on top of the collagen sponge to fill the coronal part of the socket and socket sealing will be performed with a new layer of collagen sponge (superficial collagen layer) and criss-cross suture to stabilize the graft in place
干预措施: Ridge preservation (Procedure)
Group II
including 8 patients, preservation of extraction sockets will be done with collagen spong alone and criss-cross suture
干预措施: Ridge preservation (Procedure)
Group III
control group, including 8 patients, preservation of extraction sockets will be done with atraumatic extraction and left for spontaneous healing with criss -cross suture
干预措施: Ridge preservation (Procedure)
结局指标
主要结局
Ridge preservation using collagen sponge alone or combined with xenograft clinical and histological
时间窗: 4 months
evaluate and compare the clinical outcomes to width and height of socket preservation using the Biologically-oriented Alveolar Ridge Preservation (BARP) versus Collagen Sponge (CS), all compared to negative control
次要结局
未报告次要终点
研究者
Zeinab Shalaby
lecturer of oral medicine, periodontology, diagnosis and radiology Department faculty of Dental Medicine Al-Azhar University
Faculty of Dental Medicine for Girls