Transcrestal Graftless Schneiderian Membrane Elevation by Self-tapping Dental Implant
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation
研究概览
简要总结
This prospective clinical trial aims to evaluate the efficiency, safety, and reliability of a minimally invasive graftless transcrestal sinus lifting approach with simultaneous dental implant placement in patients with edentulous posterior maxilla and limited residual bone height.
The study investigates bone formation beneath the Schneiderian membrane, implant stability, osseointegration, and long-term implant survival.
详细描述
This prospective clinical study evaluates a minimally invasive graftless sinus lifting technique using a transcrestal approach with simultaneous implant placement in the posterior maxilla.
The procedure involves tenting the Schneiderian membrane without the use of grafting material, relying on blood clot formation and natural bone regeneration beneath the elevated membrane.
Radiographic and clinical evaluations will be performed preoperatively, immediately postoperatively, and at 6 months to assess bone formation, implant stability, and osseointegration.
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
盲法说明
This is an open-label single-arm prospective clinical study. No masking will be applied to participants, care providers, investigators, or outcome assessors.
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 18-80 years.
- •Patients with edentulous posterior maxilla.
- •Residual bone height approximately 4-6 mm.
- •Indicated for transcrestal sinus membrane elevation.
- •Good general health (ASA I or II).
- •Ability to provide written informed consent.
- •Willingness to attend follow-up visits.
排除标准
- •Severe systemic diseases (ASA III or above).
- •Uncontrolled diabetes mellitus.
- •Active sinus pathology.
- •History of radiotherapy in the head and neck region.
- •Heavy smokers (>10 cigarettes/day).
- •Pregnancy or lactation.
- •Untreated periodontal disease.
- •7. Poor oral hygiene.
研究组 & 干预措施
Graftless Transcrestal Sinus Lift with Simultaneous Implant Placement
Participants with edentulous posterior maxilla and residual bone height of approximately 5 mm will undergo minimally invasive graftless transcrestal sinus membrane elevation followed by simultaneous placement of a 10 mm length and 4-4.5 mm diameter dental implant.
干预措施: Graftless Transcrestal Sinus Membrane Elevation with Simultaneous Implant Placement (Procedure)
结局指标
主要结局
Amount of Newly Formed Bone After Graftless Transcrestal Sinus Elevation
时间窗: 6 months after surgery
Radiographic assessment of the amount of newly formed bone in the elevated sinus space using CBCT.
次要结局
未报告次要终点
研究者
Samar Ahmed Ali Al-Ansi
Postgraduate Researcher, Faculty of Dentistry, Sana'a University
Sana'a University