Comparative assessment of analgesic (Topical and systemic) and chewing gum in the management of orthodontic pain: A randomized controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- topical analgesic form is similarly potent as compared to its systemic analgesic form in management of orthodontic pain.
研究概览
简要总结
Pain is a subjective response showing large individual variations, when arising from orthodontic force application is a major concern for patients, parents and clinicians. Diclofenac is a potent anti-inflammatory drug that is well suited for local use in the oral cavity. The drug results in decreased production of Prostaglandins hence, reduce inflammation or swelling and pain.
“It is hypothesized that diclofenac oral rinse would be a better alternative to its systemic administration, in terms of patient acceptance"
There are several other non-pharmacological methods for orthodontic pain relief and masticatory stimulation of the periodontal ligament such as the chewing of gum or use of bite wafers has been reported to alleviate pain induced by the application of orthodontic force. Chewing rubbery materials allows blood flow in compressed areas of the periodontal ligament and prevents the formation of pain-inducing inflammatory metabolites, thereby attenuating pain perception. Hence, this study is planned to assess and compare the efficacy of diclofenac (local and systemic form-oral route) and chewing gum (non sticky and sugar free) with control group in the management of orthodontic pain
**Procedure of conduction of research: -**The participants will be evaluated on the basis of mild to moderate crowding followed by the inclusion criteria. Randomized allotment will be done in the four groups respectively. A 0.014†Cu NiTi wire will be placed in patient’s mouth after bonding is done with conventional metal brackets. Pain relief remedies will be provided as per group allotments with a questionnaire which will be collected in the next appointment and instruction will be given. The filling of questionnaire on proper time will be assessed through telephonic reminders.
Predesigned pain questionnaire including visual analog scale will be given to the patients and will be collected in the next appointment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 32.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with mild to moderate Crowding
- •Patients within age group 18-32 years 3.
排除标准
- •Patients with active periodontal diseases
- •Allergic to diclofenac
- •Autoimmune disease
- •Pregnant and lactating Women
- •Cardiovascular disease
- •History of gastritis or peptic ulcer.
结局指标
主要结局
topical analgesic form is similarly potent as compared to its systemic analgesic form in management of orthodontic pain.
时间窗: baseline (2 hours after initial wire placement), upto 4 days
次要结局
- Analgesic oral rinse and xylitol chewing gum can be an efficient modality in orthodontic pain management as well as more convenient to the patints.(baseline (2 hours after initial wire placement), upto 4 days)
研究者
Dr sarfaraz akhtar
darshan dental college and hospital