Quantitative Assessment of Bone Comparing the Minimally Invasive Ridge Splitting Versus the Conventional Open Flap Technique
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 16
- 试验地点
- 4
- 主要终点
- Implant stability.
研究概览
简要总结
The goal of this clinical trial is to compare implant stability, and crestal bone loss, when using minimal invasive ridge splitting versus convenient open flap technique. The main question is Does Minimal Invasive Implant ridge splitting ("transmucosal" without flap) influence the implant stability and crystal bone loss, when compared with the conventional open flap techniques? Researchers will compare Group A: Minimal Invasive Implant ridge splitting and Group B: Triangular flap technique is used to see if there is significant difference between the two groups when measuring implant stability, and crestal bone density.
详细描述
Diagnostic stage:
Explanation of the operative procedure and obtaining the participants consent. Comprehensive clinical examination and understanding of participants chief complains and needs will be carried out.
CBCT acquisition:
Cone Beam Computed Tomography (CBCT) scans for the participants will be Taken preoperatively to determine the following:
- Bone density (D1 & D4 for exclusion, while D2 & D3 shall be included)
- To confirm the ridge mapping indicating alveolar ridge class IV. (Where height is adequate > 10mm, while width is "3-4 mm").
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
- Single (Participant)
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with atrophic posterior mandibular ridge with edentulous area 30-40 mm, minimum width 3-4 mm, and adequate height indicated for implant placement >9 mm.
- •Patient with Bone density D2 and D
- •Good general systemic condition.
- •Committed patient to attend follow up appointment.
排除标准
- •Patients with systemic diseases that may affect the healing process of hard or soft tissues (e.g., uncontrolled diabetes mellitus).
- •Patient on medication that could hinder the normal healing process (e.g., steroids, immunosuppressant)
- •Patients with intra-bony lesions or infections.
- •Patient with bad habits (e.g. alcohol or Substance abuse).
- •Patient who received head and neck radiotherapy or chemotherapy in the last 10 years.
研究组 & 干预措施
Minimal Invasive Implant ridge splitting
Using minimally invasive implant placement in atrophied ridge without mucoperiosteal flap, and specially designed implant shaped expanders.
干预措施: Minimally invasive implantation (Procedure)
conventional open flap ridge splitting implantation.
Using the conventional open flap technique with mucoperiosteal elevation to expose the ridge with the use of conventional bone expanders and chisels.
干预措施: Open flap procedure for ridge expansion. (Procedure)
结局指标
主要结局
Implant stability.
时间窗: immediate postoperative, 1, 2, and 3 months post operative.
Implant Stability Quotient (ISQ) evaluation via Ostell device for implant stability measurement, it measures on a scale from 1 to 100 and is a measure of the stability of an implant, less than 60 indicates low stability, 60-69 indicates medium stability, 70 and more indicates high stability. Method of aggregation: Mean and standard deviation. .
CBCT assessment
时间窗: measurement points: preoperative, immediately postoperative, and 12 months postoperative, unless indicated otherwise e.g., Complications).
Bone density at the implant site in House field unit. A Hounsfield unit reading of 1250 and above indicates D1 bone. A Hounsfield reading between 850 to 1250 units is indicative of D2 bone. A Hounsfield reading between 350 and 850 units is indicative of type D3 bone. A Hounsfield reading between 150 and 350 units is indicative of D4 bone. Method of aggregation: Mean and standard deviation.
次要结局
- Postoperative Pain(to be completed by day 7 postoperative, describing the pain felt.)
- Operation Time(Time of the procedure from the beginning to the end.)
研究者
Bassem Emad AbdElMoneim
Oral and Maxillofacial Surgeon
The Royal College of Surgeons of Edinburgh