Subperiosteal Minimally Invasive Aesthetic Ridge Augmentation Technique With and Without Low Level Laser Therapy: A Comparative Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Gain in Alveolar ridge width in millimeters
研究概览
简要总结
The present study is a human, prospective, randomised controlled clinical trial conducted to explore the outcome of a minimally invasive ridge augmentation technique with and without low level laser therapy. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
Twenty healthy individuals satisfying the inclusion and exclusion criteria were recruited for the study. A detailed, thorough medical and dental history was obtained and each patient was subjected to comprehensive clinical and radiological examination. All patients were informed about the nature of the study, the surgical procedure involved, potential benefits and risks associated with the surgical procedure and written informed consent were obtained from all patients.
All the patients were treated with subperiosteal minimally invasive aesthetic ridge augmentation technique. the test group of ten were given low level laser therapy as an adjunct. The clinical and radiographic parameters were recorded at baseline and six months postoperatively.
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)
入排标准
- 年龄范围
- 21 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single or multiple edentulous sites with Seibert's class 1 defects corresponding to colognes 1 and 2
- •ASA 1 and 2
- •Patients with an esthetic concern
- •Good oral hygiene
排除标准
- •Seibert's class 2 defects
- •ASA 3 and 4
- •Osteoporosis
- •uncontrolled diabetes
- •immunosuppression
- •radiation therapy and bisphosphonate therapy
- •Gingival thickness less than 2 mm
结局指标
主要结局
Gain in Alveolar ridge width in millimeters
时间窗: 6 months
gain in alveolar ridge width at the agumented site in millimeters will be measured using Cone Beam Computed Tomography (CBCT) at baseline and six months
次要结局
- Change in Bone density in Hounsefield's units(6 months)
- Patient related outcomes of the surgical procedure in relation to 1) pain 2) discomfort and 3) swelling(one week)
研究者
Dr Prabhuji MLV
PROFFESSOR
Krishnadevaraya College of Dental Sciences & Hospital