Comparative Study of Peri-Implant Tissue Response With and Without Topical Vitamin D Treatment During Implant Placement: A Randomized Controlled Trial.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 20
- 试验地点
- 1
研究概览
简要总结
Background: Vitamin D has a positive role in calcium absorption and bone metabolism. Vitamin D deficiency has been implicated in the cause for early dental implant failure. Topical vitamin D application has been shown to offer good effects in osseointegration of dental implants in animal studies.
Aim: To compare over a follow up period of 6 months the clinical response and peri-implant crestal bone level changes around dental implants that are placed with and without filling the surgically prepared osteotomies with vitamin D solution prior to placement of the implant fixture.
Materials and Methods: A sample size of 20 implant sites has been calculated. These edentulous sites will be randomly assigned to test group (n=10) wherein the implant fixture will be placed in a surgically prepared osteotomy that has been filled with vitamin D solution, and the remaining to a group (n=10) wherein no such topical application of vitamin D in the osteotomy will be done prior to insertion of fixture.. The peri-implant crestal bone levels on an intraoral radiograph will be measured at time point of immediately after fixture surgery and after 3- and 6-months after surgery. Standardization of radiograph angle and position will be obtained by using a customized pre-fabricated radiograph holding stent. The peri-implant scores of modified Plaque Index, Peri-Implant Mucosal Index, modified Sulcus Bleeding Index, Misch’s Implant Mobility Scale, Peri-Implant Probing Depth, Peri-Implant Mucosal Margin level, Peri-Implant Clinical Attachment level, and the presence or absence of peri-implant suppuration. The full mouth scores of Plaque Index, Gingival Index, and percentage of Sulcus Bleeding sites will also be recorded.
Data Analysis. The changes in peri-implant crestal bone levels levels, peri-implant clinical scores and periodontal scores will be compared between the two groups at respective time-points. The data will be analyses statistically with standard analysis of variance at a level of significance of p less than or equal to 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant 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
- •systemically healthy Indian patient
- •each an age of at least 18 years
- •partially edentulous
- •sufficient bone height/width for implant placement
- •ready to come for 6-month recall.
排除标准
- •previously diagnosed with vitamin D deficiency with serum vitamin D level of lessthan 10 ng/ml
- •diagnosed with chronic kidney disease, osteoporosis, ulcerative colitis, Crohn disease, or celiac disease
- •long term use of medication like phenytoin, phenobarbital, and rifampin
- •active periodontal infection (no periodontal pocket depth greater than 3 mm at the time of implant placement).
- •unresolved extraction wounds or inadequate bone at the time of implant placement
- •lack of motivation and/or compliance
- •moderate/heavy smoking
- •uncontrolled diabetes mellitus
- •a medical condition that contraindicates surgery 11.
研究者
Dr Pranjal Sati
Uttaranchal Dental And Medical Research Institute Majri Grant Dehradun Uttarakhand