The Effect of Vitamin D Supplementation on Dental Implant Osseointegration: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)
研究概览
简要总结
Dental implantation is a new technique for the single or more missing tooth replacement. Dental professionals might utilize the findings of this investigation to generate local data and learn more about how vitamin D affects bone metabolism and implant osseo-integration. The long-term success of dental implants would also be enhanced and preserved with the right medical use of vitamin D
详细描述
Treatment option for replacing lost natural teeth is dental implants. Many factors are essential for the dental implant osse-ointegration, consisting of bone quality and volume, surgical approach and complications and host-associated factors like deficient nutritional status. By influencing bone metabolism, vitamin D, together with calcium, is essential for osseo-integrating implants. The significance of vitamin D supplementation in osseo-integration has received little attention in dental literature; there is little data involving people, and the majority of investigations have used animal models. Due to numerous environmental and dietary factors, international data is not applicable to our population. Latest study shows that 54% of the individuals were vitamin D deficient and 31% had vitamin D insufficiency in Pakistan.(Riaz et al., 2016) As well as Pakistani are less likely to expose to sun due to their full clothing, use of veil and Burqah. This research was therefore assessed the impact of vitamin D supplementation during dental implant osseointegration. In this research, the local data have been generated and dental implants in the presence of vitamin-D supplementation were tested for effectiveness.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Care Provider)
盲法说明
Groups A and B were created out of all patients who had signed up. Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks , whereas patients in group B received a placebo. Patients were blinded to the study medication. The implants were then allowed to cure adequately and submerged for a further three months. Patients were summoned back three months later to un-cover the implant.
The both groups were compared for the difference of osseo-integration at 3 months, as well as difference of osseo-integration were compared with respect to implant site (maxilla and mandible).
Additionally, change in vitamin D levels were also assessed pre-operatively and post-operatively at 3 months.
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients of age 18 to 45 years
- •Patients of either gender
- •Patients undergoing for dental implant
- •Patients with Vitamin-D insufficiency
排除标准
- •Patients with any bone regenerative therapy prior to dental implants
- •Patients with arthritis
- •Patients with periodontal disease
- •Patients with bleeding disorders
- •Patients with poor oral hygiene
- •Patients with uncontrolled hypertension and diabetes mellitus
- •Patients with severe vitamin D deficiency
- •Patients with chronic renal disease
- •Patients on proton pump inhibitors
- •Pregnant women
研究组 & 干预措施
Group A
Patients in group A received 5000 IU of vitamin D3 orally every day for 12 weeks
干预措施: Vitamin D3 (Drug)
Group B
Patients in group B received 400mg of vitamin E orally every day for 12 weeks
干预措施: Vitamin E 400 (Drug)
结局指标
主要结局
Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100)
时间窗: 12 weeks
It will assess the difference in osseo-integration among patients undergoing dental implant procedures. Osseo-integration is measured by evaluating the ISQ value (Implant Stability Quotient, ranging from 1-100) using radiographic and clinical assessments with Ostell. A higher ISQ value indicates greater stability of the dental implants in the surrounding bone tissue. The assessment is conducted three months post-implantation, following a period of implant curing.
次要结局
- Evaluation of Mean Change in Serum Vitamin D Levels in Dental Implant Patients with and without Vitamin D Supplementation at a Tertiary Care Hospital(12 weeks)
研究者
Dr. Atif Iqbal
Associate Professor
Ziauddin University