Impact of Photobiomodulation on Pain During Orthodontic Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 32
- 试验地点
- 4
- 主要终点
- Visual analog scale
研究概览
简要总结
The objective of this study is to determine to effect of PBM Ortho, a photobiomodulation device, in adult patients undergoing clear aligners orthodontic treatment. We hypothesize that PBM Ortho will reduced the orthodontic associated pain in the clear aligner patients. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva.
详细描述
Pain associated with orthodontic treatment is one of the main causes of treatment discontinuation and patient non-cooperation. Several treatment modalities have been studied to alleviate orthodontic pain which includes pharmacological, mechanical, and behavioral approach. One potential treatment is the application of photobiomodulation (PBM) therapy which is a form of light therapy. The objective of this study is to determine to effect of PBM therapy in adult patients undergoing clear aligners orthodontic treatment. This effect will be evaluated by recording the pain on visual analog scale given to the patients before the placement of clear aligners and collecting saliva. The patients will be provided with active PBM Ortho device and sham PBM device (placebo, which will look similar to the active device) to use them at home for one 8 minutes application for 7 days (4 minutes per arch, upper or lower). The pain scale sheets will also be given to the patients to fill them every day for 7 days. The inflammatory protein associated with pain present in the saliva will be collected on Day 1 (24 hours after clear aligner treatment start), Day 4 (fourth day of treatment), and Day 7 (after 1 week from the treatment start). On the last visit, the device and pain scale sheets will be collected from the patients. If successful, this device therapy will reduce the orthodontic associated pain and improve patients' compliance and cooperation.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •Systemically healthy male and female patients (age 20 to 65), i.e., do not suffer from systemic illness nor require medication during the saliva collection period.
- •Permanent dentition, with Little's Irregularity Index (LII) of 2 mm or greater for the upper and lower arch.
- •Orthodontic treatment using clear aligners via non-extraction therapy.
- •Patient is available for follow-up visits.
- •Patient is able and willing to comply with the requirements of this trial protocol.
- •Non-smoker with no use of chewing tobacco.
- •Good oral hygiene.
- •Caries free.
- •No sign of periodontal disease.
排除标准
- •Systemic diseases
- •Medication use for the past 6 months; specially use of anti-inflammatory (e.g., NSAIDs), antiviral, antibiotics.
- •Active dental caries.
- •Any periodontal problem including bleeding, tooth mobility, bone loss, attachment loss, deep pockets.
- •Sleep apnea and other airway pathologies.
结局指标
主要结局
Visual analog scale
时间窗: Day 7
Study endpoint for effectiveness in decreasing the pain perception during orthodontic tooth movement. Pain intensity will be scored between 0 (no pain) and 10 (worst imaginable pain) on the numeric scale. Pain intensity does not have a unit to describe. The pain intensity will be recorded in both groups at Day 0 (after the placement of the first composite attachments on the teeth but before the seating of the first clear aligner), and then every day for 7 consecutive days.
次要结局
- Saliva analysis(The saliva will be collected on Day 7)