Clinico-radiographic comparison of dental implants placed with low-speed drilling without irrigation and conventional drilling with irrigation – A randomized controlled study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Peri implant crestal bone level at mesial and distal aspect of the implant
研究概览
简要总结
Background: The present study aims to investigate the changes in crestal bone levels and the changes in implant scores after placing implants using two different drilling-protocols, i.e., low-speed-drilling without irrigation and conventional-drilling with saline irrigation, over a follow-up of 9 months.
Nh Null hypothesis: there is no difference in the mesial distal crestal bone levels, peri implant mucosal index value, modified plaque index score, modified sulcus bleeding index scores, implant mobility scale, peri implant sulcus probing depth between implants placed after drilling with 800-400 rpm with copious saline irrigation and implants placed after intermittently drilling with 200-100 rpm without irrigation.
Material and Methods: Twenty participants will be enrolled from a dental teaching institute. Participants who fulfill the inclusion criteria will be randomly divided equally in two study groups: 1) test group: low-speed-drilling at 200-100 rpm without irrigation and 2) control group: conventional-drilling at 800-400rpm with saline irrigation. The changes in proximal radiographic crestal bone levels will be measured at baseline (immediately after placement of implant), and after 3-, 6-, 9- months. Changes in crestal bone levels will be compared at time-intervals of 3-, 6- and 9- months. These changes will also be calculated as a percentage of implant length. Clinical and radiographic scores of modified Plaque Index, Peri-implant Mucosal Index, modified Sulcus Bleeding Index, Misch’s Clinical Implant Mobility Scale, Peri-implant sulcus probing depth, Peri-implant clinical attachment level, Presence of peri-implant suppuration, Presence of peri-implant radiolucencies will be evaluated after 6-, 9 months in both groups. Second stage surgery will be performed after 3-4 months and cement retained implant crowns will be delivered. Data analysis will be performed using paired t-test between both groups and a p-value of ≤0.05 was considered statistically significant.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Healthy Indian patient Partially edentulous Sufficient bone height/width for implant placement Ready to come for 6-month recall.
排除标准
- •Active Periodontal Infection.
- •Unresolved extraction wounds or inadequate bone at the time of implant placement Lack of motivation and/or compliance Moderate/heavy smoking Bruxism Any medical condition that contraindicates surgery Pregnancy.
结局指标
主要结局
Peri implant crestal bone level at mesial and distal aspect of the implant
时间窗: R0- radiograph taken soon after placement of implant. | R3- Radiograph taken 3 months after placement of implant and before placing the final prosthesis. | R6- Radiograph taken 6 months after placement of implant, 3 months after placement of final prosthesis. | R9- radiograph taken after 9 months of implant placement surgery
次要结局
- Peri implant mucosal index(modified Plaque index)
研究者
Dr Aaron F Gomes
Uttaranchal Dental and Medical Research Institute