Clinical and Radiographic Comparison of Double-Flap Incision, Modified Periosteal Releasing Incision, and Coronally Advanced Lingual Flap to Periosteal Releasing Incision for Flap Advancement in Partially Edentulous Patients Undergoing Guided Bone Regeneration Using Titanium Mesh: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 2
- 主要终点
- Flap advancement
研究概览
简要总结
Guided Bone Regeneration (GBR) is a reliable method to augment insufficient bone volume for implant placement. Membrane exposure is a major complication which is avoided by tension free primary closure. Classically Periosteal Releasing Incision (PRI) is performed to advance the flap. The aim of this trial is to compare Double Flap Incision (DFI), Modified Periosteal Releasing Incision (MPRI) & Coronally Advanced Lingual Flap (CALF) to PRI in terms of flap advancement, postoperative pain & swelling, membrane exposure and the amount of bone gain clinically and radiographically in GBR procedures.
详细描述
Study setting:
The patients will be assigned from the outpatient clinic of "The Faculty of Oral and Dental Medicine, Cairo University". Surgical procedures will be held in the periodontology clinic of the faculty. The recruited sample would be from the Egyptian urban and rural population.
Eligibility Criteria:
Inclusion criteria:
- Partially edentulous patients in the mandibular posterior region.
- Patients with healthy systemic condition.
- Insufficient ridge width (< 5mm).
- Presence of proper inter-arch space for placement of the implant prosthetic part.
- Adequate soft tissue biotype (≥ 2mm).
- No clinical evidence of active periodontal disease or oral infections.
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 (Participant, Outcomes Assessor)
盲法说明
Care provider and investigator cannot be blinded as they are involved in the surgical procedure so blinding is not feasible.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Partially edentulous patients in the mandibular posterior region.
- •Patients with healthy systemic condition.
- •Insufficient ridge width (< 5mm).
- •Presence of proper inter-arch space for placement of the implant prosthetic part.
- •Adequate soft tissue biotype (≥ 2mm).
- •No clinical evidence of active periodontal disease or oral infections.
排除标准
- •Patients with systemic conditions that may interfere with the results of the study.
- •Patients with local pathological defects related to the area of interest.
- •Unmotivated, uncooperative patients with poor oral hygiene.
- •Patients with habits that may jeopardize the implant longevity and affect the results of the study such as smoking, alcoholism or para-functional habits.
- •History of bone associated diseases or medication affecting bone metabolism e.g.; bisphosphonate treatment.
- •History of radiation therapy in the head or neck region.
- •Current anti-tumor chemotherapy.
- •Inflammatory and autoimmune diseases of the oral cavity.
结局指标
主要结局
Flap advancement
时间窗: Intraoperative
Flap advancement in millimeters will be measured as the difference before and after Double flap Incision, Modified Periosteal Releasing Incision, Coronally Advanced Lingual Flap, and Periosteal Releasing Incision in millimeters using periodontal probe.
次要结局
- Postoperative Pain(7 days postoperatively)
- Postoperative Swelling(7 days postoperatively)
研究者
Nada Zazou
Principle Investigator, assistant Lecturer, Modern Sciences and Arts University (MSA).
Cairo University