LED Therapy Using 830 Nm in the Mandibular Third Molar Surgery: Double-blind Randomized Clinical Trial.
试验速览
- 阶段
- 早期 1 期
- 状态
- 尚未招募
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Pain
研究概览
简要总结
LED Therapy for third molar surgery
详细描述
LED Therapy using 830 nm in the mandibular third molar 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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
This study was a double-blind study in which the patient, the surgeon, and the statistician were all unaware of whether the patient received treatment or a placebo control light . Only the operator using the LED light was aware of this information. The assigned group was recorded on sealed and opaque envelopes. These cards were prepared by an independent person who was not involved in the study protocol. Once the patient underwent extraction and agreed to participate in this trial, this independent person opened the envelope to reveal the allocation.
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Healthy Asians;
- •20-55 years old;
- •Having mandibular third molars that are inappropriately erupted and need to be extracted due to caries, orthodontic reasons and/or periodontal disease;
排除标准
- •Underlying diseases: diabetes, cardiovascular disease, coagulation disorder, osteoporosis, hypertension, neurological disease, psychological disorder, tumor, systemic infection or cyst at the extraction site;
- •Women who are preparing for pregnancy, pregnant or breastfeeding;
- •Medication history: use of analgesics, anti-inflammatory drugs and/or antibacterial drugs 2 weeks before tooth extraction, need for systemic medication other than acetaminophen after surgery, allergy to acetaminophen, use of anticoagulants, bisphosphonates;
- •Bad habits, such as addicted to smoking, drinking, etc.;
- •Volunteers who have recently participated in other clinical trials;
研究组 & 干预措施
Control Group
The irradiation protocol was the same as that of the experimental group, and the light source used was simulated light. After surgery, patients took ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days.
干预措施: Antibiotic (Drug)
Treatment Group
LED light was irradiated 4 times (830 nm, 50 mW/cm2, 60 J/cm2, 1200 s) on D1 (before and after surgery), D2, and D3, which was extraoral irradiation. After surgery, ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days were taken.
干预措施: photobiomodulation (Device)
Treatment Group
LED light was irradiated 4 times (830 nm, 50 mW/cm2, 60 J/cm2, 1200 s) on D1 (before and after surgery), D2, and D3, which was extraoral irradiation. After surgery, ibuprofen 0.3 g bid for 3 consecutive days, metronidazole 0.1 g tid, and cefaclor 0.375 g bid for 7 consecutive days were taken.
干预措施: Antibiotic (Drug)
结局指标
主要结局
Pain
时间窗: Day 7
Visual Analogue Scale，VAS
Swelling
时间窗: Day 3; Day 7
Facial swelling was measured in 2 planes: the distance between the tragus and lip commissure and the distance between the gonion and external canthus of the eye.
Trismus
时间窗: Day 3; Day 7
Trismus was evaluated by measuring the maximum mouth opening between the edges of the upper and lower central incisors with a calibrated ruler.
次要结局
- Quality of life score(Day 3; Day 7)