Comparative Evaluation of the effect of Low-Level Laser Therapy using two different wavelengths on post-surgical healing in patients undergoing Piezoelectric Flapless Implant Surgery
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- If there is a significant difference in post-operative healing between patients undergoing LLLT at 650 nm wavelength as compared to 940 nm wavelength following piezoelectric flapless implant surgery
研究概览
简要总结
The study would be conducted over a period of 1.5 years. The study would involve 34 patients
requiring implant placement due to missing teeth. The patients would be divided into two equal
groups of 17 each. Group 1 would receive LLLT with a diode laser at a wavelength of 650 nm,
while Group 2 would receive LLLT at 940 nm. Both groups would undergo implant insertion
using piezoelectric flapless surgery, and LLLT would be administered before surgery and at 24
and 36 hours post-surgery. Healing outcomes would be assessed using the Inflammatory
Proliferative Remodeling (IPR) scale on 3rd day 14th day and 6th week post operatively1
.
Sample Size
The study would include a total of 34 patients which was determined using G Power Software
(version 3.0.10). The sample size calculation considered an effect size of 0.912, a 5% level of
precision, a 95% confidence level, and 80% power. Patients would be divided equally into two
groups, with 17 patients in each group.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 20.00 Year(s) 至 40.00 Year(s)（—）
- 性别
- All
入选标准
- •a) Patients within age group of 20-40 years with missing teeth needing implant placement b) Willingness to participate in the study and provide informed consent c) Availability for follow-up visits as per the study protocol.
- •d) Patients with adequate bone height and width to accommodate implant of appropriate dimension.
排除标准
- •e) Patients with contraindications to Low-Level Laser Therapy (LLLT) such as photosensitivity, active cancer in the treatment area or history of radiation therapy to the head or neck region f) Patients having known systemic diseases contraindicated for implant placement g) Inability or unwillingness to comply with the study protocol or attend follow-up visits h) Pregnant and lactating women i) Use of medications or substances known to interfere with wound healing/patients with history of intake of immunosuppressive drugs, anti coagulants and anti-cancer drugs three months prior to the study j) Patients undergoing orthodontic treatment k) Patients having known history of bone disorders (e.g. osteoporosis, osteoarthritis) l) Severe periodontal disease or active oral infections at the implant site.
结局指标
主要结局
If there is a significant difference in post-operative healing between patients undergoing LLLT at 650 nm wavelength as compared to 940 nm wavelength following piezoelectric flapless implant surgery
时间窗: 3rd day, 14th day and 6th week post operatively
次要结局
未报告次要终点
研究者
Dr Priyanshu Priyam
Manav Rachna DentaL College And Hospital