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临床试验/NCT04070001
NCT04070001已完成不适用

Comparison of the Effects of Ibuprofen and Low-Level Laser Therapy on Orthodontic Pain By Means of Interleukin 1-Beta and Substance P Levels in the Gingival Crevicular Fluid

Yeşim KAYA1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
60
试验地点
1
主要终点
Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: evels of mediators such as interleukin 1-Beta and Substance P.

研究概览

简要总结

Early orthodontic pain is usually caused by the insertion of elastomeric separators to the mesial and distal of the tooth to be banded in order to create adequate space for proper placement. Recent studies have demonstrated that the pain reaches its peak at 24 hours and then gradually decreases within 7 days The intensity of this pain is sometimes perceived as extremely high to cause a significant number of patients to discontinue the treatment.

Nonsteroidal anti-inflammatory drugs, which block the prostaglandin synthesis through inhibiting the cyclooxygenase activity, is one of the most common methods used to manage the orthodontic pain. It has been reported that these drugs decrease the orthodontic tooth movement rate, in addition to many systemic side effects such as gastric and duodenal ulceration, coagulation disorders, congestive heart problems and allergic effect.

The application of low-level laser therapy (LLLT) also reported being efficient in accelerating orthodontic tooth movement and in alleviating orthodontic pain without any apparent side effects. LLLT is thought to reduce the pain by increasing the local blood flow, inhibiting the secretion of inflammatory substances, inducing the release of neurotransmitters, altering the conduction and excitation of peripheral nerves and stimulating the endorphins release. On the other hand, literature review on the effectiveness of LLLT in alleviating orthodontic pain observed after elastomeric separator placement (ESP) exhibited conflicting results. While LLLT was found to be effective in some studies, the others refuted its effectiveness.

When studies on alleviating orthodontic pain observed after ESP were reviewed, it was determined that the effects of many drugs and LLLT were evaluated subjectively by VAS. Furthermore, only in one study, the effects of ibuprofen and LLLT were compared using PGE2 levels in GCF and VAS. Based on that, this study was aimed to compare the effects of ibuprofen and LLLT in alleviating orthodontic pain observed after ESP through IL-1β and SP levels in GCF and VAS.

详细描述

Pain is defined as a sophisticated experience that includes sensations evoked by, and reactions to noxious stimuli. During the different phase of orthodontic treatment, pain is developed in response to the tension and pressure zones generated in the periodontal ligament following the force application. This leads to the secretion of inflammatory mediators such as histamine, serotonin, dopamine, glycine, cytokines, leukotrienes, prostaglandins and substance P that stimulate free nerve endings resulting in the perception of pain.

Early orthodontic pain is usually caused by the insertion of elastomeric separators to the mesial and distal of the tooth to be banded in order to create adequate space for proper placement. Recent studies have demonstrated that the pain reaches its peak at 24 hours and then gradually decreases within 7 days. The intensity of this pain is sometimes perceived as extremely high to cause a significant number of patients to discontinue the treatment.

Nonsteroidal anti-inflammatory drugs, which block the prostaglandin synthesis through inhibiting the cyclooxygenase activity, is one of the most common methods used to manage the orthodontic pain. It has been reported that these drugs decrease the orthodontic tooth movement rate, in addition to many systemic side effects such as gastric and duodenal ulceration, coagulation disorders, congestive heart problems and allergic effect.

The application of low-level laser therapy (LLLT) also reported being efficient in accelerating orthodontic tooth movement and in alleviating orthodontic pain without any apparent side effects. LLLT is thought to reduce the pain by increasing the local blood flow, inhibiting the secretion of inflammatory substances, inducing the release of neurotransmitters, altering the conduction and excitation of peripheral nerves and stimulating the endorphins release. On the other hand, literature review on the effectiveness of LLLT in alleviating orthodontic pain observed after elastomeric separator placement (ESP) exhibited conflicting results. While LLLT was found to be effective in some studies, the others refuted its effectiveness.

The intensity of orthodontic pain was evaluated either subjectively by visual analog scale (VAS) or objectively by chemical analysis of gingival crevicular fluid (GCF), in previous studies. The analysis of GCF is a useful and non-invasive method for detecting the biochemical mediators released during tooth movement with reasonable sensitivity. In GCF, pro-inflammatory mediators such as interleukin 1-beta (IL-1β) and prostaglandin E2 (PGE2) and neuropeptides such as Substance P (SP) have been related separately to pain. When studies on alleviating orthodontic pain observed after ESP were reviewed, it was determined that the effects of many drugs and LLLT were evaluated subjectively by VAS. Furthermore, only in one study, the effects of ibuprofen and LLLT were compared using PGE2 levels in GCF and VAS. Based on that, this study was aimed to compare the effects of ibuprofen and LLLT in alleviating orthodontic pain observed after ESP through IL-1β and SP levels in GCF and VAS. The null hypothesized was that there was no difference between the effects of ibuprofen and LLLT in orthodontic pain relief.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Supportive Care
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 30 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • Being older than 18 years of age,
  • Requiring ESP at the beginning of orthodontic treatment for banding of maxillary first molars,
  • Intact maxillary dentition (exception of third molars),
  • Fully erupted maxillary first molars without any treated or not treated apical lesions,
  • Tight contacts between the posterior teeth,
  • No pregnancy and lactation,
  • The absence of systemic and periodontal diseases and chronic or neural pains,
  • Currently not using analgesics or antibiotics that interfere the pain perception,
  • No contradiction to the use of ibuprofen,
  • The absence of gingival pigmentation where the laser will be applied.

排除标准

  • Previous orthodontic treatment,
  • Falling to complete the questionnaire and to continue to the follow-up appointments.

研究组 & 干预措施

Ibuprofen group

Active Comparator

Ibuprofen group received 1-dose 400-mg Ibuprofen 1 hour before elastomeric separator placement

干预措施: 400 Mg Ibuprofen (Drug)

Laser group

Active Comparator

Laser groups received a single irradiation of low-level laser immediately after elastomeric separator placement.

干预措施: laser application (Device)

Control group

Placebo Comparator

Control group received placebo lactose tablets 1 hour before elastomeric separator placement.

干预措施: placebo tablets (Other)

结局指标

主要结局

Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: evels of mediators such as interleukin 1-Beta and Substance P.

时间窗: This primary outcome was evaluated through the study completion, on average 1 year.

The intensity of pain observed after elastomeric separator placement was evaluated through levels of mediators such as interleukin 1-Beta and Substance P in gingival crevicular fluid objectively.

Comparison of the effects of ibuprofen and laser therapy in alleviating orthodontic pain observed after elastomeric separator placement: visual analogue scale.

时间窗: This primary outcome was evaluated through the study completion, on average 1 year.

The intensity of pain observed after elastomeric separator placement was evaluated through visual analogue scale subjectively.Visual analogue scale is a 10-cm horizontal line with the number 0 representing no pain and the number 10 representing the worst pain.

Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: levels of mediators such as interleukin 1-Beta and Substance P.

时间窗: This primary outcome was evaluated trough the study completion, on average of 1 year.

The intensity of pain observed after elastomeric separator placement was evaluated through levels of mediators such as interleukin 1-Beta and Substance P in gingival crevicular fluid objectively.

Evaluation the intensity of orthodontic pain after ibuprofen administration and laser application: visual analogue scale.

时间窗: This primary outcome was evaluated trough the study completion, on average of 1 year.

The intensity of pain observed after elastomeric separator placement was evaluated through visual analogue scale subjectively. Visual analogue scale is a 10-cm horizontal line with the number 0 representing no pain and the number 10 representing the worst pain.

次要结局

未报告次要终点

研究者

发起方
Yeşim KAYA
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Yeşim KAYA

Assistant professor

Yuzuncu Yıl University

研究点 (1)

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