Single-Session Extraoral Photobiomodulation Reduces Early Postoperative Pain But Not Edema or Trismus After Impacted Mandibular Third Molar Extraction: 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
- 70
- 试验地点
- 1
- 主要终点
- Postoperative Pain
研究概览
简要总结
Postoperative pain, edema, and trismus are frequent complications following impacted mandibular third molar surgery. This randomized controlled trial evaluated the effects of a single-session extraoral dual-wavelength photobiomodulation (PBM) (650+904 nm) applied immediately after extraction. The study aimed to assess the impact of this therapy on postoperative pain, edema, trismus, and quality of life (QoL) on days 2 and 7.
详细描述
This prospective, parallel-group randomized controlled clinical trial was designed to evaluate the effects of a single-session extraoral photobiomodulation (PBM) application on postoperative outcomes following the surgical extraction of impacted mandibular third molars.
The study included 70 patients (age range: 17-25 years) with asymptomatic mesioangular impacted mandibular third molars (Pell-Gregory Class IB). Participants were randomly assigned to either a PBM group (n=35) or a control group (n=35). All surgical procedures were performed by a single surgeon using a standardized technique.
Following the surgery, the PBM group received a single session of extraoral therapy using a dual-wavelength GaAlAs laser (650 nm + 904 nm) for 10 minutes, with a total energy of 270 J. The probe was held in stationary contact over the mandibular angle-ramus region. The control group received no laser application. Postoperative pain was evaluated using a 100-mm Visual Analog Scale (VAS) on days 2 and 7. Secondary outcomes, including facial edema and trismus, were measured at baseline, day 2, and day 7 post-surgery. Additionally, Oral Health-Related Quality of Life (OHRQoL) was assessed using a 100-mm VAS scale at the specified time points.
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
- 17 Years 至 25 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Indication for extraction of an impacted mandibular third molar in the mesioangular position.
- •Asymptomatic tooth in Pell-Gregory Class IB position.
- •Absence of systemic disease (ASA I status).
- •Healthy status of the impacted tooth and surrounding tissues.
- •Adequate oral hygiene.
- •Absence of malignant or premalignant oral lesions.
排除标准
- •Pregnancy or lactation.
- •Regular use of non-steroidal anti-inflammatory drugs or antibiotics within the preceding week.
- •Presence of a diagnosed psychiatric disorder.
- •Active smoking.
研究组 & 干预措施
Control Group
Participants underwent the same standardized surgical extraction protocol but received no additional photobiomodulation therapy.
PBM
Participants received a single 10-minute session of extraoral dual-wavelength photobiomodulation (650+904 nm) immediately following the surgical extraction.
干预措施: Dual-wavelength GaAlAs laser (650+904 nm) (Device)
结局指标
主要结局
Postoperative Pain
时间窗: Baseline, Postoperative Day 2, and Postoperative Day 7.
Postoperative pain assessed using a 100-mm visual analog scale (VAS; 0 = no pain, 100 = worst imaginable pain)
次要结局
- Postoperative Edema(Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.)
- Trismus(Preoperatively (baseline), Postoperative Day 2, and Postoperative Day 7.)
- Oral Health-Related Quality of Life (OHRQoL)(Postoperative Day 2 and Postoperative Day 7.)
研究者
Kubilay Isik
Professor
Konya Necmettin Erbakan Üniversitesi