Comparative evaluation of Implant Stability and Bone Density in implants placed in the maxillary arch using osseodensification and reverse surgical drilling techniques A randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- implant stability
研究概览
简要总结
This is a paired split mouth randomised controlled trail comparing and evaluating the implant stability and bone density in two different drilling protocols i.e. reverse drilling protocol and osseodensification drilling protocol in partially or completely edentulous patients receiving atleast 2 implants fixed prosthesis in maxillary arch. Patients will be recruited after giving participants information sheet in the simplified language and after taking consent for the trail. A total of 24 implants in 12 patients, one osteotomy site will be prepared with reverse drilling technique and another osteotomy site will be prepared with densah burs and this will be randomly allocated in each patient’s left or right side of the maxilla as per the computer generated random numbers. After this the implant stability will be checked at baseline, 1, 3 and 6 months after implant placement and bone density will be checked at baseline with the RFA device and bone density will be checked at baseline and after 6 months of implant placement with the HU unit in sectional CBCT. This data will be analysed and results will be statistically evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •a Subjects more then or equal to 18 years b Patient who needs minimum of 2 implants in the maxillary arch c If completely edentulous patients needs fixed implant prosthesis d Both the implants site nearly of the same density e Able to provide consent.
排除标准
- •a Patients with medical history in which any dental intervention would be contraindicated b Patients with known allergy to dental implant material (Titanium) c Patients in which sinus lift procedures should be carried out for the implant placement d Patients in which bone graft is needed at the implant placement site e Patient who is current smoker or quieted smoking less then 1 year f Patients undergoing radiotherapy cancer therapy or drug that interfere with the study g completely edentulous patients needed implant supported removable prosthesis h Presence of systemic diseases producing oral manifestations i Patients suffering from any bone related systemic diseases j Patients with any local or systemic disease, condition or medication that might compromise health of the periodontium k Pregnant and lactating women.
结局指标
主要结局
implant stability
时间窗: implant stability at baseline, 1, 3 and 6 months after implant placement | bone density at baseline and after 6 months of implant placement
bone density
时间窗: implant stability at baseline, 1, 3 and 6 months after implant placement | bone density at baseline and after 6 months of implant placement
次要结局
未报告次要终点
研究者
Dr Vishva Vachhani
K M Shah Dental College and Hospital