Effects of Diabetes on Two Short Implants Splinted Using One- and Two-stage Techniques: Split-mouth Study With One-year Follow-up.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 32
- 主要终点
- Evaluation of the status of osseointegration
研究概览
简要总结
The goal of this clinical trial is to compare one- and two-stage techniques for short implant surgery in diabetes. The main questions it aims to answer are:
- Is one-stage short implant surgery at risk of implant osseointegration in diabetic patients compared to two-stage surgery?
- Is one-stage short implant surgery associated with a risk of implant survival (at one-year follow-up) in diabetic patients compared to two-stage surgery?
- What are the effects of one- and two-stage short implant surgery on the marginal bone loss or ISQ (implant stability coefficient - resonance frequency analysis device measurement) values of the implant in diabetic patients?
Participants will come for their 3rd, 6th and 12th month controls.
- Participants will receive two adjacent short implants.
- A randomly selected one of these short implants will undergo a one-stage implant surgery, and the other a two-stage implant surgery.
- Data will be obtained through non-invasive evaluation methods during the surgery and subsequent control stages.
Researchers will also test one- and two-stage short implant surgeries in a control group of healthy individuals. Thus, the effects of diabetes on these two techniques will be better understood by comparing them with the healthy control group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The maxillary and mandibular posterior region (distal part of the canine in each quadrant) must have toothless space for two adjacent short implants.
- •The edentulous space must have a vertical bone height of at least 5 mm. (Distance to maxillary sinus and alveolar nerve)
- •The edentulous space should not require horizontal bone augmentation. (for implants with diameters 3.7 - 4.1 - 4.7 - 5.3)
- •Bleeding on probing should be less than 10%. There should be no pathological pockets in any tooth.
- •Participant should not smoke more than 10 cigarettes per day.
- •More than 6 months must have passed since the tooth extraction from the edentulous area.
- •Should not have bruxism
- •If it is diabetes, the HbA1c value should be greater than 6.5, and if it is healthy control, the HbA1c value should be between 4 and 5.
排除标准
- •Having psychological problems
- •Smoking more than 10 cigarettes per day
- •Pregnancy status if female patient
- •Having a medication or disease that will cause abnormal post-operative bleeding
- •Alcohol and drug use
结局指标
主要结局
Evaluation of the status of osseointegration
时间窗: Three months after the implant is placed in the bone. (At the end of three months)
Fusion of the dental implant with the bone at the microscopic level. Osseointegration will be evaluated as successful or unsuccessful. Successful osseointegration is defined by no mobility in the implant, no radiolucency around the implant on radiography, and no pain in the implant. Otherwise, the osseointegration of the implant is considered unsuccessful.
One-year survival of the implant
时间窗: At the end of 12 months of follow-up from the surgery in which the implant was placed in the bone
To observe whether the implant is performing its function. The implant continues to support the tooth connected to it.
次要结局
- Implant Stability Quotient (ISQ Value)(1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone. At the end of three months)
- Marginal bone level change(1- Surgical stage where the implant is placed; 2- Three months after the implant is placed in the bone; 3- Six months after the implant is placed in the bone; 4- Twelve months after the implant is placed in the bone)
研究者
Ömer Faruk Okumuş
Assistant Professor
Erzincan University