The Evaluation of Pain Severity in Flapless Dental Implant Placement Using Laser-induced Incisions: A Split Mouth Randomized Clinical Trial Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Pain Severity
研究概览
简要总结
The goal of this split-mouth randomized clinical trial study was to investigate the effect of using a laser on pain and discomfort following flapless dental implant surgery. It was hypothesized that laser did not have any impact on post-op pain. Therefore, the study aimed to compare pain and discomfort following flapless dental implant surgeries with or without a laser.
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 (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
- •Adult human subjects agreed to participate in the study and return on follow-up times
- •Subjects eligible for receiving dental implants
- •Subjects with an edentulous area in the posterior of the mandible bilaterally 3- Subjects with sufficient bone width and height (>5 mm width, and >10 mm height) at the implant sites
- •Subjects with sufficient keratinization tissue at the implant sites
排除标准
- •Subjects refused to return for follow-up or refused study enrollment.
- •Subjects with uncontrolled systemic diseases
- •Subjects younger than 18 years
- •Subjects receiving psychotropic drugs
研究组 & 干预措施
Laser-induced Incision
The Biolase Epic 10 diode laser device (Biolase, USA) with 940 nm wavelength, 10 W of max output power, 20 KHz of pulse repetition rate, and continuous pulse mode was used.
干预措施: Laser-induced Incision (Device)
Punch Incision
The soft tissue Osstem punch (South Korea) was used.
干预措施: Punch Incision (Procedure)
Punch Incision
The soft tissue Osstem punch (South Korea) was used.
干预措施: Implant Placement (Procedure)
Laser-induced Incision
The Biolase Epic 10 diode laser device (Biolase, USA) with 940 nm wavelength, 10 W of max output power, 20 KHz of pulse repetition rate, and continuous pulse mode was used.
干预措施: Implant Placement (Procedure)
结局指标
主要结局
Pain Severity
时间窗: Patients were visited at 24, 48, 72 hours, and 7 days after insertion.
Measured using the visual analogue scale (VAS): 0-3 mild pain, 4-6 moderate pain, and 7-10 sever pain.
次要结局
未报告次要终点
研究者
Reza Tabrizi, DMD
Associate Professor of Oral and Maxillofacial Surgery
Shiraz University of Medical Sciences