A Randomized Comparative Study on Internal Sinus Lifting With Simultaneous Implant Placement Using Two Different Techniques
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Mean of implant insertion quantity (ISQ) value
研究概览
简要总结
This study was conducted at Ege University, School of Dentistry, Izmir, Turkey. Patients enrolled require implant placement to the atrophic posterior maxilla. Patients were treated with either the specifically designed drills or the osteotomes. The outcome variables were primary stability, marginal bone loss, implant survival, and patient-reported outcomes. The investigators aimed to compare the treatment outcomes of two different techniques used in dental implant placement with internal sinus lifting.
详细描述
This prospective, randomized clinical study was conducted at the Ege University School of Dentistry and Department of Oral and Maxillofacial Surgery. Patients with atrophic maxillas and at least one tooth loss in this region were included. Randomization was performed to assign the patients to study groups. Patients treated with internal sinus lift using osteotome and implant surgery were assigned to Group 1, and patients treated with internal sinus lift using specifically designed drills and implant surgery were assigned to Group 2. At six months postoperatively, the healing cap was inserted during the second stage of surgery.
All implants were assessed based on primary stability (using implant stability quotient and torque value), marginal bone loss (as millimeters), and implant survival (as a percentage). Also, patient-reported outcomes were collected, including pain (using a visual analog scale), analgesic consumption (number of drugs taken during a week), and oral health impact profile survey).
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
- Single (Investigator)
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
- •Unilaterally or bilaterally missing teeth in the posterior maxilla,
- •Residual bone height (4 mm to 6 mm),
- •Completed periodontal and oral hygiene treatment,
- •American Society of Anesthesiologists (ASA) score of I or II,
- •> 18 years old,
- •Willingness to participate
排除标准
- •Infection or pathology related to maxillary sinus and surgical site,
- •Tooth extraction within six months in the surgical site,
- •Previous maxillary sinus surgery,
- •Parafunction,
- •Medical conditions associated with impaired or delayed wound healing,
- •Smoking habit and alcohol or drug abuse,
- •Pregnancy or nursing
研究组 & 干预措施
Control Group
Sinus lifting and implant placement with osteotomes
干预措施: Sinus lifting and implant placement with osteotomes (Procedure)
Test Group
Sinus lifting and implant placement with specifically designed drills
干预措施: Sinus lifting and implant placement with specifically designed drills (Procedure)
结局指标
主要结局
Mean of implant insertion quantity (ISQ) value
时间窗: at surgery
Calculation of ISQ value for each implant
Mean of torque value
时间窗: at surgery
Calculation of torque value for each implant
次要结局
- Marginal bone loss(through study completion, an average of 1 year)
- Implant survival(through study completion, an average of 1 year)
- Pain Score(at postoperative first week)
- Analgesic consumption(at postoperative first week)
- Oral health impact profile questionnaire(preoperatively, at postoperative first week, and at postoperative 6 months)
研究者
Gözde Işık
Associated Professor
Ege University