A Clinical and Radiological Comparison of Osseodensification Versus Conventional Implant Site Preparation Protocol During Dental Implant Placement. A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- change from baseline in crestal bone level
研究概览
简要总结
The present study is a human, prospective, randomised controlled clinical trial conducted to explore and compare the clinical and radiological outcome of Osseodensification protocol with conventional implant site preparation protocol. The trial is in accordance with the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
详细描述
Twenty two dental implants were placed in twelve 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 received Norris implant. the implant site preparation technique being Osseodensification protocol for the test group and conventional implant site preparation protocol for the control group, eleven in each group. The clinical and radiographic parameters were recorded at baseline, immediate post implant placement, six months and twelve 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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Single/multiple missing teeth in the maxillary anterior/posterior region.
- •Bone density of D2 or D3 (Carl E.Misch).
- •Patients between 18-75 years.
- •Patients who demonstrate good plaque control (PI<10%) and showing good compliance.
- •Patients willing to participate in the study.
排除标准
- •Insufficient density or height of residual ridge.
- •Patients with bleeding disorder or on anticoagulant therapy.
- •Pregnant and lactating females.
- •Patients with history of smoking.
- •Use of systemic antibiotics in the past 3 months.
- •Patients treated with any medication known to cause periodontal changes.
- •Drug and alcohol abuse.
- •Occlusal interferences.
- •Patients with history of titanium allergy.
- •Immunocompromised state and debilitating disease.
- •Malignancy or radiotherapy/chemotherapy for malignancy.
- •Systemic diseases that would negatively influence wound healing.
结局指标
主要结局
change from baseline in crestal bone level
时间窗: 1 year
Digital radiographs (radiovisiograph-RVG) were standardised using radiographic paralleling technique and positioning device and custom fabricated bite-block at baseline and follow up.Mesial and distal peri-implant radiographic bone level were recorded in millimetres on the digital radiographs using Digimiser image
primary implant stability
时间窗: immediate post implant placement
the primary implant stability was measured during implant placement using Insertion Torque Value(ITV).
change from baseline in bone density
时间窗: 1 year
A Multislice CT was used for scanning the implant site pre operatively, just after implant placement and 1 year post implant placement to measure the change in bone density. It was performed using a tube voltage of 120 kV(kilovolt) and a tube current of 40 mA(milliampere). The occlusal plane of the patient was set perpendicular to the floor base using ear rods. The axial images was reconstructed with 0.625 mm thick slices at 0.625 mm interval and a 1.75 mm field of view(FOV) image analysis software
次要结局
- change from baseline in keratinized mucosa width(1 year)
- change from baseline in ridge width(1 year)
- Patient reported pain evaluation (Visual Analog Scale)(1 year)
研究者
Dr Prabhuji MLV
Professor
Krishnadevaraya College of Dental Sciences & Hospital