Comparative Effects of 650 nm and 810 nm Diode Laser Photobiomodulation on Postoperative Pain, Analgesic Use, and OHRQoL After Dental Implant Surgery: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Postoperative Pain Intensity Using Numeric Rating Scale (NRS)
研究概览
简要总结
The goal of this clinical trial is to evaluate the effectiveness of laser light therapy, known as photobiomodulation (PBM), in reducing pain after dental implant surgery. The study involves adult patients receiving a single dental implant in the upper posterior (back) area of the mouth. Participants are randomly assigned to receive PBM using either a 650 nm red diode laser, an 810 nm infrared diode laser, or a sham (inactive) laser.
The study aims to assess whether PBM therapy can reduce pain during the first three days after surgery, decrease the need for pain medication, and improve oral health-related quality of life (OHRQoL). PBM is applied immediately after surgery and again within 48 hours. Pain intensity is measured at multiple time points (2, 6, 12, 24, 48, and 72 hours), analgesic use is recorded, and OHRQoL is evaluated using a standardized questionnaire.
详细描述
This randomized, double-blind, sham-controlled clinical trial assessed the short-term effects of photobiomodulation (PBM) using 650 nm and 810 nm diode lasers on postoperative pain, analgesic intake, and oral health-related quality of life (OHRQoL) following single dental implant placement in the posterior maxilla.
Methods:
Sixty participants were randomized into three equal groups (650 nm PBM, 810 nm PBM, or sham). All underwent a standardized H-design flap surgery and implant placement. PBM was applied at three points around the implant (buccal, palatal, crestal) using 100 mW power for 60 seconds per point (total 18 J), repeated within 48 hours.
Outcomes:
Primary outcome: Pain intensity measured using an 11-point Numeric Rating Scale (NRS) at 2, 6, 12, 24, 48, and 72 hours after surgery.
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
- Double (Participant, Outcomes Assessor)
盲法说明
Participants and outcome assessors were blinded to group allocation. The operator administering the laser therapy was not blinded due to the nature of the device used. Sham PBM was visually identical to active laser settings to maintain blinding for all other parties.
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20-65 years.
- •Indicated for single dental implant placement in the posterior maxilla.
- •ASA physical status I or II.
- •Good oral health.
- •Willingness and ability to comply with study procedures and follow-up schedule.
- •Able to provide written informed consent.
排除标准
- •Use of analgesics, NSAIDs, or corticosteroids within 48 hours prior to surgery.
- •History of alcohol abuse or regular consumption of >14 drinks/week (men) or >7 drinks/week (women), or withdrawal within the last 6 months.
- •History of chronic pain or long-term pain medication use.
- •Need for grafting, sinus lift, or complex implant procedures.
- •Pregnant or breastfeeding.
- •Uncontrolled systemic disease (e.g., uncontrolled diabetes, immunodeficiency).
- •History of epilepsy, photosensitivity, or contraindications to laser therapy.
- •Allergy or contraindication to acetaminophen.
- •Previous implant or surgical treatment in the same site within the past 6 months.
- •Heavy smokers (>12 cigarettes/day) or individuals who quit smoking within the past 6 months.
结局指标
主要结局
Postoperative Pain Intensity Using Numeric Rating Scale (NRS)
时间窗: 2, 6, 12, 24, 48, and 72 hours after surgery
Postoperative pain intensity was assessed using an 11-point Numeric Rating Scale (NRS: 0-10) at 2, 6, 12, 24, 48, and 72 hours after surgery. Participants recorded the maximum pain experienced since the previous interval. Pain was analyzed in two ways: (1) Temporal analysis of mean NRS scores across Day 1 (defined as the highest score within 24 hours), Day 2, and Day 3 to assess daily pain evolution; and analysis of specific time points on Day 1 (2, 6, 12, 24 hours) to explore early postoperative pain dynamics. (2) Categorical analysis of NRS scores classified into five pain severity levels: no, mild, moderate, severe, and unbearable pain. Group comparisons were conducted using ANOVA or Kruskal-Wallis tests for continuous data and Chi-square tests for categorical distributions.
次要结局
- Analgesic Intake (Acetaminophen 1000 mg)(2, 6, 12, 24, 48, and 72 hours after surgery)
- Oral Health-Related Quality of Life (OHRQoL) Using OHIP-14(Baseline, 1 week post-implant placement, and 1 week post-prosthesis placement)
研究者
Dr. Mohammad Mahmoud Yehya Abdussalam
Principal Investigator
National Institute of Laser Enhanced Sciences