Prosthetics Dental Implant-based Rehabilitation in Patients With Loss of Teeth and Mineral Metabolism Disorders Due to Vitamin D3 Imbalance
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 384
- 试验地点
- 4
- 主要终点
- Primary Stability of dental implant
研究概览
简要总结
Interventional retrospective prospective randomized clinical trial (RCT) in parallel groups.
The sample size is 384 patients with loss of teeth and vitamin D imbalance. All patients will undergo or underwent dental implantation after additional investigations which reveal vitamin D imbalance (<30 ng/ml or <75 nmol/l).
The 1 group will include 192 patients who will be or were operated on with dental implants after stabilization of vitamin D level with a help of an endocrinologist.
The 2 group will include 192 patients who will be or were operated on during the treatment of vitamin D imbalance prescribed by the endocrinologist.
The possible difference between groups can be considered the change of dental implants survival time and bone resorption level depending on the level of vitamin D and treatment time by the endocrinologist.
详细描述
A purpose is to increase the efficiency of rehabilitation of patients with loss of teeth and mineral metabolism disorders due to vitamin D3 imbalance using an interdisciplinary approach to dental implantation.
Retrospective prospective RCT in parallel groups includes 384 patients with loss of teeth and vitamin D3 imbalance who will undergo or underwent the dental implantation on the base of Oral Surgery Department of Borovskiy Institute of Dentistry of I.M.Sechenov First Moscow State Medical University (Sechenov University) and private dental clinic 'Society with limited responsibility (SLR) Topaz 2000' from 2010 till the 2021 year: prospective part will include 100 patients, the retrospective part will include 284 patients.
The counted sample size according to loss of teeth prevalence in Russia on the base of Sechenov University and private dental clinic Topaz 2000 is equal to 384 patients.
Randomization will be assured by surgeons blinded to endocrinologic status of patients who underwent or will undergo the dental implantation.
All patients will be included in 2 groups: 1 group will include patients (n=192), 25-50-years-old, with loss of teeth and mineral metabolism disorders due to vitamin D3 imbalance (<30 ng/ml, or <75 nmol/l) who will undergo dental implant placement after stabilization of vitamin D3 levels (>30-60 ng/ml, or 75-150 nmol/l for the process of treatment and monitoring); 2 group will include patients, 25-50-years-old, with the loss of teeth and mineral metabolism disorders due to vitamin D3 imbalance (n=192) who will undergo the dental implantation during treatment by an endocrinologist before the stabilization of vitamin D3 level in the blood.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Care Provider, Outcomes Assessor)
盲法说明
Surgeons will be blinded to the endocrinologic status of patients who underwent or will undergo the dental implantation
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signing of written informed consent of the patient to participate in a study
- •Age from 25 to 50 years old
- •Established diagnosis: tooth loss (K08.1- ICD 10), vitamin D3 imbalance.
- •Patients who are medically stable
排除标准
- •Refusal of the patient from further participation in the study
- •Pregnancy diagnosed after the inclusion into the trial
- •Non-compliance by the patient with postoperative recommendations.
- •Residence address change
结局指标
主要结局
Primary Stability of dental implant
时间窗: Day 0
It can be assessed with the volume of torque during dental implant insertion with the physio-dispenser according to its program
Secondary Stability of dental implants after surgery
时间窗: Days 60-90
During the inserting of healing abutment the stability of dental implant will and was measured with the help of device Penguin RFA (Integration Diagnostics, Sweden, Registration 29th of December 2017 RZN No 2017/6664) (Quotient of stability depends on the scale from 1 to 99 ) based on resonance frequency analysis through the handpiece of device MulTipeg. The use of device will not and did not lead to the loss or mobility of dental implants.
次要结局
- Colour of peri-implant tissues according to clinical examination after surgery(Days 3-7)
- Oedema of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)(Days 10-14)
- Peri-implant pockets presence according to clinical examination(Days 365-366)
- Colour of peri-implant tissues according to clinical examination after surgery (for additional operations such bone plasty)(Days 10-14)
- Colour of peri-implant tissues(Days 365-366)
- Condition of peri-implant tissues according to X-ray or cone-bean computed tomography(Days 365-366)
- Oedema of peri-implant tissues according to clinical examination after surgery(Days 3-7)