The Effect of the Chewing Gum in Alleviating Orthodontic Pain After Separator and Initial Arch Wire Placement: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Pain assessment after separators and initial arch wire placement.
研究概览
简要总结
Pain is the most claimed complaint from orthodontic treatment. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affects patients' compliance to treatment and even becomes the main reason for discontinuing orthodontic treatment. For years, orthodontic patients have reported using analgesics during orthodontic treatment to ease the pain. However, analgesics have many side effects such as allergic reactions, bleeding disorders, gastric ulcers, liver toxicity and their potential influence in slowing down tooth movement. This study aimed to investigate the effectiveness of chewing gums in pain reduction in Malaysian multi-ethnic orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in our future practice.
详细描述
Orthodontic treatment have been shown to cause varying degrees of discomforts and pain to the patients. Fear of pain has contributed to patients' avoidance of seeking orthodontic treatment, affect patients' compliance to the treatment and even become a main reason of discontinuing orthodontic treatment. Patients have reported using of analgesic particularly NSAIDS and Paracetamol during orthodontic treatment to ease the pain. However, NSAIDS have been associated with various side effects such as allergic reactions, bleeding disorders and gastric ulcers had raised the concern of orthodontists. Studies on animals have shown that NSAIDS slower the rate of tooth movement, hence affecting orthodontic treatment efficacy. Paracetamol have been reported to cause liver toxicity in the case of over dosage.
The action of chewing the gum can produce forces to temporary displace the teeth sufficiently to allow blood flow through compressed area, preventing the build-up of metabolic products, thus reduce the pain severity. In addition, non-sugared chewing gum has anti-caries effect which is very important to prevent caries formation during orthodontic treatment.
This study aimed to investigate the effectiveness of chewing gum in pain reduction in orthodontic patients and to explore the possibility of chewing gum to be recommended as a suitable substitute for analgesics in future practice.
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
- Double (Investigator, Outcomes Assessor)
盲法说明
Blinding of participants is not possible during allocation, treatment and data collection. However, blinding can be done during data processing, analysing and data collection for secondary outcome on appliances failure rate.
入排标准
- 年龄范围
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients about to undergo orthodontic treatment with maxillary and mandibular fixed appliances
- •Orthodontic treatment include the extraction of the permanent first or second premolars
- •Age 16 years and above
排除标准
- •Significant medical problem or cleft lip and palate.
- •Pregnant lady
- •Occurrence of using analgesics or antibiotics
- •History of asthma or unstable asthma the last year
- •Oral surgery in the previous 4 weeks
研究组 & 干预措施
intervention group
Participants will receive Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum. They will be instructed to chew the gum for pain relief after the separator and initial arch wire placement if required. Chew the gums for 10-12 minutes and as much as they want whenever they feel discomfort or pain. They are free to take any medication when necessary and respond to the questionnaires on the amount of chewing gum and analgesics used.
干预措施: Wrigley Extra Strawberry Flavour Sugar Free Chewing Gum (Other)
Control group
Participants will not receive any prescription after the separators and initial arch wires placement. They will be specifically asked not to chew chewing gum. As in the intervention group, they can take any medication when they feel necessary and respond to the questionnaires on the amount of analgesics used.
结局指标
主要结局
Pain assessment after separators and initial arch wire placement.
时间窗: At 48 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Pain assessment after separators and initial arch wire placement.
时间窗: At 6 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
Pain assessment after separators and initial arch wire placement.
时间窗: At 24 hours after separators and initial arch wire placement.
Level of pain on the Numerical pain rating scale (NRS)
次要结局
- Recorded appliances breakages.(Immediately after the separator and archwire placements until 2 days after the separator and archwire placement)
- Reported use of chewing gum and analgesics.(from 24 hours to 48 hours after the separator and archwire placements)
- Reported use of chewing gum and analgesics.(Immediately after the separator and archwire placements until up to 6 hours)
- Reported use of chewing gum and analgesics.(from 6 hours to 24 hours after the separator and archwire placements)