Flapless Mini-incision Implant Surgery vs Conventional Flap or Flapless Implant Surgery: A Prospective, Randomized, Single Blind, Clinical and Radiographic Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Pain score
研究概览
简要总结
evaluate the clinical efficacy of the flapless mini-incision method compared to conventional flap and flapless punch methods
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 (Outcomes Assessor)
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
- •Adult patients with adequate bone height and width at the site of implant 120 placement, and good quality bone to support a primary stability of at least 30 Ncm and D2 bone quality according to Lekholm and Zarb classification), based on preoperative radiographic assessment
- •Clinical evidence of optimal periodontal health with no active periodontal disease in adjacent teeth
- •No history of systemic illnesses that could affect bone health and wound heal- ing (e.g. uncontrolled diabetes mellitus, osteoporosis, renal osteodystrophy…etc.)
- •No history of or requirement for bone grafting and augmentation at the implant site
- •Willingness to participate in the study and attend prescribed follow-up appointments
排除标准
- •Patients with history of radiation therapy for head and neck cancer
- •Patients with history of allergy and hypersensitivity to local anesthetic agents, and biomaterials used in dental implants
- •Pregnant women and lactating mothers
- •History of smoking (>2 cigarettes per day)
- •Patients under treatment with anti-resorptive or anti-neoplastic medication such as bisphosphonates, chemotherapeutic agents, and monoclonal antibodies (e.g. Denosumab
研究组 & 干预措施
Flapless mini-incision
A flapless mini incision is used to place the dental implants
干预措施: Flapless mini-incision (Procedure)
Flapless punch
A flapless punch is used to place the dental implants
干预措施: Flapless punch (Procedure)
Conventional flap
The Standard commonly used surgical flap is used to place the dental implant
干预措施: Conventional flap (Procedure)
结局指标
主要结局
Pain score
时间窗: 18 months postoperatively
Assessment of patient's pain level using Visual Analog Scale (VAS) which would be compared between groups. VAS is a visual scale 0 to 10 with 10 the highest pain score and 0 the lowest, the patient is asked to identify the pain level at the different timestops for comparison between groups
次要结局
- Soft-tissue healing(18 months postoperatively)
- Radiographic bone level(18 months postoperatively)
研究者
Alaa Emara
A.Professor
Cairo University