A Comparison of Conventional and Mini Single Implant retained Mandibular Overdenture in controlled diabetic individuals
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- 1. To assess the crestal bone loss around the 2-piece single conventional and mini implant retained mandibular overdenture.
研究概览
简要总结
Implant retained overdentures have now become the choice of treatment for removable complete overdenture. Implants such as mini-implants and conventional implants have been used to stabilize the mandibular overdenture. (Weerapan et al 2016). Diabetes Mellitus is a metabolic disorder and considered a relative risk for dental implant therapy. As there is delayed wound and bone healing and compromised immunity among diabetic patients, many of them are denied the benefits of dental implant therapy (Yadav et al. 2018). 2-piece Mini-implants are often being recommended because of their reduced diameter (<3.0 mm) which enables insertion in narrow ridges. Mini-implants are also interesting from an economic perspective, due to their reduced cost compared with standard fixtures and lower operative time needed (Griffitts et al. 2005).Systematic reviews evaluating the clinical viability of single implants retaining overdentures concluded that their survival and patient satisfaction increased even with a single implant retaining the overdenture (Batista et al 2019). Based on the data available, crestal bone loss is affected by implant design, formation of biologic width, implant design, implant surface, insertion depth, platform switching, postsurgical manipulation and micro gap and stability between the implant and abutment (Maier, F.M. 2016). There have been various studies on the number of dental implants used to stabilize the denture but there has been limited studies regarding the comparison between a 2-piece single conventional and mini implant for a mandibular overdenture used in diabetic individuals. Such a treatment is more cost-effective and affordable for patients. Hence, there’s a need for this study.
**Aim of the study:**The aim of the study is to evaluate the crestal bone loss and the patient satisfaction between Conventional and Mini single implant supported mandibular overdenture
**Objectives of the study:**1. To assess the crestal bone loss around the conventional and mini single implant supported mandibular overdenture. 2. To assess the patient satisfaction for conventional and mini single implant supported overdenture.
Methodology: 22 participants satisfying the predetermined inclusion and exclusion criteria will be selected for this study. The participants will be randomly assigned into two groups (Group A – Conventional implant and Group B – Mini implant). Each group will have 11 participants; a single implant will be placed in symphysis of the mandible. Conventional loading protocol will be followed after 3 months. Crestal bone loss will be assessed with CBCT at mesial, distal, buccal, lingual sites immediately after implant placement, 3rd month (loading), and 9th month from implant placement. Patient satisfaction will be evaluated with a questionnaire at the end of 9th month.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Investigator Blinded
入排标准
- 年龄范围
- 50.00 Year(s) 至 70.00 Year(s)(—)
- 性别
- All
入选标准
- •Subjects with completely edentulous maxillary and mandibular arches
- •Patients aged between 50-70 yrs
- •Both male and female patients
- •Patients with Glycosylated haemoglobin (HbA1c) levels at 6–6.5 %
- •Extraction site healed for at least 12 weeks
- •Adequate bone width and height to place an implant of at least 2.4 mm diameter and 10 mm length.
排除标准
- •Subjects requiring bone augmentation procedure before or during implant placement
- •Any Microvascular complications such as nephropathy, neuropathy and retinopathy
- •Habit of smoking, pan chewing and chronic alcoholism
- •Pre-cancerous lesions and conditions
- •Subjects with medical contra-indications for implant surgery
- •Severe bony defects in the implantation site
- •Poor neuromuscular control
- •Severe prognathism or retrognathism of jaw.
结局指标
主要结局
1. To assess the crestal bone loss around the 2-piece single conventional and mini implant retained mandibular overdenture.
时间窗: 3 months
次要结局
- 2. To assess the patient satisfaction for 2-piece single conventional and mini single implant retained overdenture.(3 months)
研究者
Dr Shivangini Gumme
Faculty of Dental Sciences, MS Ramaiah University of Applied Sciences
