Association of serum Vitamin D level and implant osseointegration - a prospective study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- implant stability
研究概览
简要总结
The success of dental implant depends upon the osseointegration of the implant which increases implant stability. Vitamin D , a steroid hormone, in its active form regulates bone mineral homeostasis by calcium and phosphorous metabolism and osteoblastic and osteoclastic activities. Adequate vitamin D level is essential for maintaining bone density as well as for healing by repair and regeneration of bone around the implant. Therefore optimal vitamin D level can improve osseointegration of implant. Vitamin D deficiency is seen worldwide and serum Vitamin D level relation to implant osseointegration is not fully understood. Hence the hypothesis of the study is that optimal serum Vitamin D level is necessary and might enhance implant osseointegration and thereby increase implant stability.
The aim of the study is to evaluate the association of serum vitamin D level and implant osseointegration.
The objectives being to evaluate periodic serum vitamin D leve, evaluate primary and secondary stability of the implant at 3rd and 6th months and to correlate the ISQ to the serum vitamin D level.
The study will be performed on 25 patients selected on the basis of inclusion and exclusion criteria with written consent of the patient.
Inclusion criteria - partial edentulous site , age - 18-50 yr , ASA class I
exclusion criteria - chronic smoker/ alcoholics , pregnant / lactating women , pt under bisphosphonates or any supplements including vitamin D and Calcium, immunocompromised patient, poor oral hygiene, patient with bone disorders or irradiation to implant site , patient not achieving primary stability
The procedure will involve routine blood investigation with serum vitamin D levels, CBCT pre- op and post- op 3rd and 6th month to compare bone regeneration around implant and insertion torque test and ISQ to measure the stability of the implant intra-op and post op at 3rd and 6th months. The CBCT and ISQ data will then be correlated to the the patient’s serum vitamin D levels intra-op and in the 3rd month and 6th month.
All the 25 patient’s data will be compared to evaluate if there exist any association between Vitamin D serum levels and implant osseointegration. The statistical analysis will be carried out using student paired T test, ANOVA, Simple linear regression and other relevant tests if found appropriate.
研究设计
- 研究类型
- Interventional
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •subjects within age group of 18 -50 years
- •partially edentulous sites
- •willing for implant prosthesis
- •belonging to ASA class I category.
排除标准
- •subjects who are chronic alcoholics or/and smokers;
- •pregnant or lactating women;
- •immunocompromised patients;
- •subjects under vitamin D, calcium or any other vitamin supplements;
- •subjects under bisphosphonates therapy;
- •subjects with poor oral hygiene;
- •subjects with bone disorders;
- •subjects with irradiation to implant placement area
- •subjects who fail to achieve primary implant stability.
结局指标
主要结局
implant stability
时间窗: 3 months
次要结局
- implant stability(6 months)
研究者
Minati Jagadev
Rajiv Gandhi University of Health Scinces