Influence of High Insertion Torque and Type of Bone on Post-operative Pain and Survival Rate of Dental Implants
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 230
- 试验地点
- 2
- 主要终点
- Post-operative pain
研究概览
简要总结
The objectives of this clinical study were to assess the effect of different ITs and bone types on POP levels and survival rates and to investigate the effect of different patient- and site-related factors on POP levels and survival rates.
详细描述
This prospective clinical study included 230 patients treated with a single tapered screw implant (Bioinnovation Dental®, Brazil). The implants were placed using the appropriate burs with a final master drill of 3.5 or 4.5 mm in diameter by one senior oral surgeon. These implants were multi-threaded, and their surfaces were both sandblasted and acid etched. Of the 230 participants, 172 received a single 5 x 10-mm implant, and 58 received a 4 x 10-mm implant.
For the higher torque range (90 - 200 Ncm), the maximum IT was recorded with an electronic digital torque measuring device (Tohnichi BTGE200CN-G, Hitachi, Japan), while a different gauge (Tohnichi BTG90CN-S, Hitachi, Japan) was used for the lower torque range (10 - 90 Ncm). All implants were placed at the crestal level and closed with a cover screw, and the flap was then sutured with non-resorbable 4/0 nylon suture (Resorba® Germany).
Pain levels were recorded at day 1, 2 and 4 and at week 1, 2 and 3 after surgery using visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever. Implants were classified into 4 groups based on the IT value; Low: 60 implants (10-29 Ncm, mean=15 Ncm); Regular: 102 implants (30-50 Ncm, mean=42 Ncm); High: 47 implants (51-100 Ncm, mean=75 Ncm); and Very high: 21 implants (101-200 Ncm, mean=170 Ncm).
Implant survival was assessed clinically and radiographically at 3, 6, 12, 24 and 36 months. The criteria for implant success according to Buser et al, were no radiolucent zone around the implant, confirmed individual implant stability, and no suppuration, pain or ongoing pathologic processes. All implants that failed to fulfill these success criteria were regarded as failures.
The effect of IT, bone type, implant location, age, gender and smoking was measured with regression analysis. Kaplan-Meier survival analysis was performed to calculate the overall implant survival probabilities. The level of statistical significance was set at p<0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •partially edentulous patients who presented with one or more missing teeth in the maxillary or mandibular jaw
- •at least18 years old, adequate oral hygiene
- •absence of infection or periodontal problems adjacent to the implant site - sufficient bone thickness with a minimum 6-mm width and 12-mm length to accommodate implants of 4 or 5 mm in diameter and 10 mm in length.
排除标准
- •uncontrolled diabetes
- •hypertension
- •pregnancy
- •bone diseases
- •use of bisphosphonates
- •heavy smoker (more than 20 cigarettes /day)
- •severe alcohol or drug use
- •patients with recent extraction of teeth and patients requiring bone and soft tissue augmentation procedures.
结局指标
主要结局
Post-operative pain
时间窗: 1 month
Pain was assessed after surgery using the 10-cm visual analog scale (VAS) ranging from 0 "no pain" to 10 "worst pain ever." The scale has no other markings along the line. Patients will be asked to record their pain level before surgery and after surgery, 24 hours after surgery, at day 2, day 4 and at week 1, week 2, and week 3.
次要结局
- Survival rate of implants(36 months)
研究者
Ahmed Aziz
Assistant Professor
University of Sharjah