The Horizontal Ridge Augmentation Using Equine Xenograft and a Collagenated Porcine Cortical Lamina: A Clinical, Radiographic and Histological Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change From Baseline in Radiological Bone Width Augmentation at 0 mm
研究概览
简要总结
The primary aim of this study is to clinically, radiographically and histologically evaluate the lateral bone augmentation of the soft porcine cortical lamina (OsteoBiol®) using equine-derived bone particles (OsteoBiol®)
详细描述
The xenograft used in this study was the Gen-Os® by OsteoBiol; The soft lamina (OsteoBiol®) used is a 35x35mm medium curved membrane of porcine origins.
The fixation system used was the Pro-fix™ Precision Fixation System, consisting of self-drilling membrane fixation screws of 1.5 mm x 3.0 mm.
Fifteen patients (1 male, 14 females) aged between 27 and 64 years old were selected from the Department of Periodontology of the Faculty of Dentistry, Saint Joseph University Beirut.
Clinical and radiographic examinations were done prior to any procedure. The edentulous area was examined to identify the availability of keratinised mucosa and the possibility of implant placement in the mesio-distal and inter-arch planes. Radiographic examination was completed using a cone beam computed tomography (CBCT) scan of the affected region, where the indication for vertical augmentation was selected and excluded from the study. All the patients were given oral hygiene instructions and prophylaxis.
Each patient received 2g of Amoxicillin one hour prior to surgery. Patients were instructed to mouthrinse with chlorhexidine 0.12% gluconate mouthwash for 1 minute. Extra-oral disinfection was made using topical chlorhexidine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 27 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •systematically healthy
- •good oral hygiene (FMPS and FMBS <20%).
- •having ridges with deficiencies in width (<4 mm, Cawood and Howell class IV) which did not allow correct implant placement.
排除标准
- •pregnant and lactating women,
- •patients suffering from a systematic disease
- •patients on bisphosphonates
- •smokers (>10 cigarettes/day)
- •patients needing vertical augmentations
结局指标
主要结局
Change From Baseline in Radiological Bone Width Augmentation at 0 mm
时间窗: Six months after the regeneration procedure
Width difference measured at the top of the crest (0 mm) at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at top of the crest (0 mm).
Change From Baseline in Radiological Bone Width Augmentation at 2 mm
时间窗: Six months after the regeneration procedure
Width difference measured at 2 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 2 mm of the top of the crest.
Change From Baseline in Radiological Bone Width Augmentation at 4 mm
时间窗: Six months after the regeneration procedure
Width difference measured at 4 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 4 mm of the top of the crest.
Change From Baseline in Radiological Bone Width Augmentation at 6 mm
时间窗: Six months after the regeneration procedure
Width difference measured at 6 mm of the top of the crest at the site of implant placement, measured in mm over superimposition of pre-operative (baseline) Cone Beam Computed Tomography and postoperative (at 6 months) Cone Beam Computed Tomography (CBCT). The value measured at 6 months minus the value measured at baseline = width difference measured at 6 mm of the top of the crest.
次要结局
- Number of Implants Placed at 6 Months From the Regeneration Procedure(Six months after the regeneration procedure)
- Change From Baseline in Radiological Bone Height Augmentation in mm Measured Buccally(Six months after the regeneration procedure)
- Bone Percentage Superficially(Six months after the regeneration procedure)
- Change From Baseline in Radiological Bone Height Augmentation in mm Measured Medially(Six months after the regeneration procedure)
- Change From Baseline in Radiological Bone Height Augmentation in mm Measured Lingually(Six months after the regeneration procedure)
- Bone Percentage Medially(Six months after the regeneration procedure)
- Bone Percentage in the Deep Cuts(Six months after the regeneration procedure)
研究者
Sarah Khalil
Principal Investigator
Saint-Joseph University