Effect of a Double Dose of Photobiomodulaton Therapy on Orthodonthic Pain Caused by Elastomeric Separators
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 2
- 主要终点
- Assesment of pain
研究概览
简要总结
It has been reported that 90% of the patients experience pain during orthodontic treat-ment. The purpose of this study was to compare the effect of a double dose of photobio-modulation (PBM) therapy on pain perception in patients having fixed appliance treat-ment.
Twenty-two patients were recruited to participate in this single-blinded, place-bo-controlled study. Four elastomeric separators were placed, mesially and distally to the upper first molar on each side. The right side of the upper jaw was treated with low-power diode laser, and the left side was a placebo, same treatment with laser switched off. Two doses of PBM therapy (660nm, 90mW) were delivered 24 hours apart. The par-ticipants filled out the questionnaire immediately after the placement of separators and before 1st laser treatment (TO), 12 hours (T1), 24 hours (T2), 2 days (T3) and 3 days after the 1st treatment (T4). At each evaluation period, the degree of pain was scored twice, one for each side.
详细描述
Placing elastomeric separators is a part of the orthodontic treatment to create space for the orthodontic bands. This initial tooth displacement induces pain and instant release bio-chemical mediators such as prostaglandin-E2, substance P and interleukin 1-beta.
It has been reported that 90% of the patients experience pain in at least one part of the orthodontic treatment. Pain starts two hours after application of orthodontic fixed appliance, raises over the next 24-36 hours, starts to decrease on day 3, and disappears within 6-7 days.There are two principal groups of methods for controlling orthodontic pain: pharmacolog-ical and non-pharmacological.
Laser photobiomodulation (PBM), also called low-level laser therapy (LLLT), is the ap-plication of the light to pathology to encourage tissue regeneration, decrease inflammation and relieving pain. The wavelength used for this purpose is in the red and infrared spectrum (600-1000nm). There is no complete understanding of the mechanisms behind PBM, however enormous upturn has been done in this part. PBM has an impact on molecular, cellular and tissue level.
Past studies in this field have demonstrated the opposite outcomes of PBM therapy on relieving the pain after the insertion of orthodontic separators. Part of the researches showed a positive effect in pain reduction and some presented no effect. The studies with positive outcomes have no consistent specification such as wavelength, dose, radiant exposure, irradiance, tip diameter, average power output, peak power (for gated mode), time, or position of the points of application.
Thus, the purpose of this study was to evaluate the efficiency of low-level diode laser in decreasing the level of pain at the beginning of an orthodontic treatment caused by elas-tomeric separators. The null hypothesis for this study was that no difference existed among laser-treated and placebo side in reducing pain caused by elastomeric separators.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
It was determined in advance that the right side of the upper jaw was treated with laser, and the left side was placebo.Placebo side was treated the same way with the difference that the laser was switched off, but with the maintained sound signal, implying laser was working, so that partici-pants were blinded to the allocation of the group, only the operator knew whether the side is laser treated or placebo.
入排标准
- 年龄范围
- 12 Years 至 19 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients aged between 12-19 years referred for orthodontic treatment, no previous orthodontic treatment, good general health , permanent dentition including second molars erupted, intact first maxillary permanent molars, good interproximal contacts on all maxillary first permanent molars, healty periodontal tissues ( gingival index=0, plaque index<1, probing depths<3mm, no peridontal attachment loss and no radiographic evidence of periodontal bone loss)
排除标准
- •gingivitis/ periodontitis
- •interproximal fillings
- •missing teeth
- •crowding or spacing in premolar or molar area
- •severe systemic disease
- •antibiotics or analgesics prescribed 15 days prior/during study
结局指标
主要结局
Assesment of pain
时间窗: 3 days
The pain was assessed with a visual analogue scale (VAS), which is a 100-mm-long hori-zontal line where one end corresponds to "no pain" and the other end indicates "worst pain possible." The participants filled out the questionnaire immediately after the placement of separators (TO) and before 1st laser treatment, 12 hours (T1), 24hours (T2) and just after 2nd laser treatment, 2 days (T3) and 3 days after the 1st treatment (T4) (Table 1). At each evalua-tion period, the degree of pain was scored twice, one for each side. Each patient was re-quired to indicate whether he/she had taken any analgesics during the recorded period.
次要结局
未报告次要终点
研究者
Vjera Perkovic
Doctor of dental medicine, orthodontist specialist
University Hospital Rijeka