Alveolar Ridge Splitting With Simultaneous Implant Placement Using Undemineralized Autogenous Tooth Graft: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 52
- 试验地点
- 2
- 主要终点
- Horizontal bone dimensions (HBDs)
研究概览
简要总结
The aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ARS) in combination with ATG, associated with immediate implant placement versus ARS in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.
详细描述
In cases of a narrow ridge, the alveolar ridge expansion technique by means of hand osteotomes with gradually increasing dimensions was introduced by Tatum and modified by Summers and it can be used regardless of the bone quality.
Searching for absolute biocompatible material and taking into account the features of the enamel and dentin, using the tooth as an autologous grafting material was first advocated. Tooth and bone are sharing many characteristics, which supports the idea that tooth could be used as a grafting material. In fact, hydroxyapatite crystals make up the tooth inorganic composition (65%). Moreover, Collagen (mostly type I) and non-collagenic proteins comprised up the tooth organic component (35%). In addition, because autologous tooth graft (ATG) is denser than bone, minimal resorption rates were found to be advantageous to autobone. For the purpose of employing ATG as a grafting material, various methods and techniques have been suggested for developing undemineralized, demineralized or partially demineralized ATG.The outcomes of utilizing undemineralized autologous tooth graft (UATG) around SDIP following RSEA have not yet been evaluated. Therefore, the current trial aimed to assess the clinical and radiological performances of UATG for the treatment of horizontal alveolar ridge deficiencies using RSEA with SDIP.
The aim of this study is to evaluate the radiographic and the clinical outcomes of application of the alveolar ridge splitting (ARS) in combination with ATG, associated with immediate implant placement versus ARS in combination with autogenous bone graft, associated with immediate implant placement in patients with horizontal bony insufficiency of alveolar ridges.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
The present clinical trial was single-blinded one as the evaluator and the statistician were both blinded. While both the implantologist or the participant were not blinded as the interventions were dissimilar.
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Good general health at the time of surgery
- •At least 3 months of healing after tooth extraction
- •Horizontally compromised alveolar ridges at least 10 mm high and 3 mm wide.
排除标准
- •A vertical bone defect in the edentulous ridge;
- •Thick cortex in the labial/buccal with less cancellous bone inside;
- •Obvious undercut on the labial/buccal side;
- •Uncontrolled periodontal conditions or other oral disorders;
- •A history of radiotherapy in the head and neck region
研究组 & 干预措施
Group I: autogenous bone graft group
11 subjects will be assigned to receive alveolar ridge splitting in combination with autogenous bone graft associated with immediate implant placement
干预措施: autogenous bone graft (Procedure)
Group II: autogenous tooth graft group
11 subjects will be assigned to receive alveolar ridge splitting in combination with undemineralized autogenous tooth graft associated with immediate implant placement
干预措施: autogenous tooth graft (Procedure)
结局指标
主要结局
Horizontal bone dimensions (HBDs)
时间窗: 12 months
The HBD alterations were assessed by measuring horizontal spacing between the external edges of labial and palatal bony plates at a level 2mm apical of the fixture platform.
Stability Quotient of Implants (SQI)
时间窗: 12-month.
The implant stability was recorded using Osstell TM. Following implant insertion, SQI readings were taken immediately, then again after six and twelve months.
Peri-implant Bone Density (PBD)
时间窗: 12 months
For consistent measurement of the PBD, 1-mm-diameter Region of interest (RI) was selected and traced 1.2 mm distant from the fixture on the cross-sectional slices followed by counting the threshold pixels inside the RI.
次要结局
- Pink esthetic score (PES)(12 months)
研究者
Walid Elamrousy
Assistant Professor of periodontology
Kafrelsheikh University