The Effect of Diode Laser 940 nm Versus Electrosurgical Device During Second Stage Implant Surgery on Bone and Soft Tissue Healing (A Randomized Controlled Clinical Trial)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 33
- 试验地点
- 1
- 主要终点
- Change in pain intensity
研究概览
简要总结
Background: Dental lasers and electrosurgical devices have been introduced a long time ago. However, limited studies are available concerning their use in the second stage of implant surgery, with the conventional surgical technique being the standard of care.
Aim of this study: To evaluate clinically and radiographically soft and hard tissue healing associated with the use of electrosurgical and laser devices and compare them with conventional surgical techniques during second-stage implant surgery.
Plan of the study: A randomized controlled clinical trial. The sample size will include patients who have an implant already placed and ready for second stage surgery recruited from the patient pool at the outpatient clinics.
Materials and Methods: Patients will be randomly allocated into the three groups. In Group (A) implant will be exposed using the conventional surgical exposure techniques with a tissue punch, the cover screw will be removed, and the healing abutment placed. In group (B) implant will be uncovered using a diode laser (940nm) in contact type with a continuous mode at a power of 1.5 watts, the laser tip will be used in a circular motion to create a small opening which will be increased till large enough to expose and remove the cover screw and place the healing abutments. In group (C) the monopolar electrosurgical device will be used in the same way as the laser tip with additional care avoiding contacting the implants during exposure.
The outcome: will be soft tissue healing and crestal marginal bone loss around implants.
Soft tissue healing will be assessed on the operative day, 2 weeks, and 4 weeks using Landry index. Crestal bone loss will be assessed using a standardized periapical x-ray at baseline and after 1 month with periapical x-ray.
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
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adequate zone of keratinized mucosa.
- •Osseointegrated Implants ready for second-stage surgery.
排除标准
- •Heavy smokers due to increased risk of infection, delayed wound healing, and poor immune response.
- •Medically compromised patients due to affection of the peri-implant health and tissue maintenance.
- •Bad oral hygiene
- •Patients with an exposed cover screw
- •Evidence of bone loss in the preoperative peri-apical radiograph.
结局指标
主要结局
Change in pain intensity
时间窗: Baseline and after 1 week
Pain intensity using a Visual Analogue Scale (VAS) score (0 to 10 cm), with a VAS marker of 0-2.50 cm for mild pain; 2.60-5.00 cm for moderate pain; 5.10-7.50 cm for severe pain; 7.60-10.0 cm for unbearable pain (11) during the operative day and the following 7 days.
Change in soft tissue healing
时间窗: after 1 and 2 weeks
Soft tissue healing using the Landry index where the following 4 parameters: tissue color, response to palpation, granulation tissue, and incision margin will be assessed with a 5-level score (1= very poor to 5= Excellent). The healing index will be recorded at 2 and 4 weeks.
次要结局
- Change in creastal bone loss(Baseline and 1 month)
研究者
Hams Hamed Abdelrahman
Assistant lecturer of DPH and Clinical statistician
Alexandria University