Analysis of Post-Endodontic Instrumentation Pain in Molars and Premolars Treated in a Single Session Associated With Photobiomodulation: A Double-blind Randomized Clinical Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 58
- 试验地点
- 2
- 主要终点
- Baseline : Analysis of pain before treatment
研究概览
简要总结
The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect f PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group with conventional treatment with photobiomodulation and the Control Group with conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
详细描述
The randomized clinical trials conducted in recent years have demonstrated that photobiomodulation (PBM) modulates postoperative pain in endodontic instrumentation, especially in the first days after the procedure. Although the results are promising, there is still low-quality evidence regarding the best dosimetric parameter applied. The objective of this double-blind, randomized controlled clinical study will be to evaluate the effect of PBM on pain after endodontic instrumentation in the single-session treatment of upper molars and premolars. The sample will consist of 58 participants treated endodontically in a single session and randomly allocated to the PBM Group (n=29): conventional treatment with photobiomodulation (808 nm, 100mW power, 3J per point, 3mm2 area, 3 points in the region of the root apices - two vestibular and one palatal, total energy of 9J - for molars and premolars 2 points - 1 vestibular and another palatal, total energy of 6J) and Control Group (n=29): conventional treatment with simulation of PBM. The primary variable of the study will be the evaluation of spontaneous pain immediately before treatment, and the participant will be reassessed for postoperative pain 24 hours after instrumentation using the visual analog scale (VAS). As secondary variables, pain prevalence, pain at 4h, 8h, and 12h after the procedure, palpation pain (vestibular and lingual), and percussion pain (vertical and horizontal) will be assessed 24 hours after the procedure, as well as the number of necessary analgesics (paracetamol) and the impact of oral health on quality of life evaluated by the OHIP 14 instrument.
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)
入排标准
- 年龄范围
- 20 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with endodontic involvement in three-rooted (upper molars) or two-rooted (upper premolars) teeth.
- •Age between 20 and 75 years.
- •Both genders.
排除标准
- •Pregnancy or lactation.
- •Patients with oncological, renal, or Type I or Type II diabetes.
- •Drug users; alcohol or tobacco users.
- •Immunocompromised patients or those using immunosuppressive medication.
- •Use of alendronate, bisphosphonates, or any systemic medication that interferes with bone metabolism.
- •Presence of associated periodontal disease.
- •Frequent exacerbations.
- •Radiolucency images with PAI stages 3, 4, or 5 (Orstavik et al., 1986).
- •Any other anatomical variation that renders single-session endodontic treatment unfeasible.
- •Teeth with previous endodontic treatment.
- •Patients with asymptomatic non-microbial apical periodontitis with any type of bruxism (clenching) or using a bite splint.
- •Teeth with more than ⅔ coronal involvement, making proper use of rubber dam isolation impossible.
- •Use of antibiotics in the last three months.
- •History of severe allergy to chlorine or its derivatives.
结局指标
主要结局
Baseline : Analysis of pain before treatment
时间窗: Immediately before the treatment
Before the treatment, regardless of the patient's randomized group, pain assessment will be conducted on the tooth and the surrounding area through palpation and percussion exams. Therefore, the patient will mark on the visual pain scale corresponding to their immediate pain, pain upon palpation, and pain upon percussion just before the treatment. The researcher will measure, using a ruler, the distance from "0" (no pain) to the patient's marked point, and this value will be taken as the comparator.
Analysis of Postoperative Pain at 4 Hours After Treatment
时间窗: 4 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 4 hours after the procedure. This scale will be exactly 10 cm and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Analysis of Postoperative Pain at 12 Hours After Treatment
时间窗: 12 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 12 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
Analysis of Postoperative Pain at 24 Hours After Treatment
时间窗: 24 hours after treatment
24 hours after the root canal filling, whether or not accompanied by photobiomodulation, the patient will return to the clinic for a reassessment of immediate pain. At this moment, the patient will be provided with a visual analog scale consisting of exactly 10 centimeters, with markings of "0" (no pain) and "10" representing maximum pain. The patient will then make a mark on this scale to indicate their current level of pain in the dental element. After the marking, the researcher will measure the distance from zero to the marked point using a millimeter ruler, and the obtained result will be recorded and statistically compared with the preoperative pain.
Analysis of Postoperative Pain at 8 Hours After Treatment
时间窗: 8 hours after treatment
After root canal obturation, all participants will receive a sheet containing a visual pain scale to document postoperative pain at 8 hours after the procedure. This scale will be exactly 10 centimeters and will range from 0 to 10, where the participant must mark a level representing their pain at that moment. This mark will be measured with a ruler, and the corresponding level will be noted.
次要结局
- Baseline : Analysis of pain upon palpation before treatment(Immediately before the treatment)
- Analysis of Palpation Pain 24 Hours After Treatment(24 hours after treatment)
- Baseline: Analysis of pain upon percussion before treatment(Immediately before the treatment)
- Analysis of Percussion Pain 24 Hours After Treatment(24 hours after treatment)
- Prevalence Analysis(24 hours after treatment)
- Analysis of the Required Analgesic Quantity(24 hours after treatment)
- Oral Health Impact Profile-14(24 hours after treatment)
研究者
Anna Carolina Ratto Tempestini Horliana
Principal investigator
University of Nove de Julho