Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial
试验速览
- 阶段
- 早期 1 期
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of traumatic ulcer
研究概览
简要总结
The study is a randomized controlled trial. The participants will be equally allocated into 2 groups to compare clinical effectiveness of curcumin mouthwash in fixed orthodontic patients during the first month of treatment.
详细描述
Patients who require fixed orthodontic appliances as part of their orthodontic treatment at the Faculty of Dentistry, Chulalongkorn University will be asked if they will volunteer for this clinical research. Participants will be informed about the objectives of the study, study process, advantages, disadvantages before making a decision to participate in this study. The consent form will be signed prior to participating in the study. A week before bracket cementation visit, a participant will attend his/her appointment for a full clinical history taking and oral screening exam by one examiner. Each participant will be allocated by a trial number and receive 3 bottles of either placebo or curcumin mouthwash accordingly. A tube of sodium lauryl sulfate (SLS)-free, non-herbal toothpaste and 1 toothbrush will be provided to each participant. Moreover, the instruction VDO will be given to participants to "Rinse with 10 ml for 1 minute, twice a day for 28 days after brushing in the morning and at night, following proper oral hygiene and avoid taking any liquid or food for 30 minutes after rinsing" in the first 28 days after bracket cementation. Then, participants will be provided with a daily record form on Google Form and requested to record every day during the trial.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
盲法说明
This clinical trial is a double-blind study that participants and examiner will be blinded to group assignment.
入排标准
- 年龄范围
- 12 Years 至 30 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Fixed orthodontic patients aged 12-30 years old
- •Fixed orthodontic appliances on at least 1 arch (at least 10 teeth per arch)
- •Patients with good general health without any systemic diseases
- •Patients who are not using any herbal toothpaste or any mouthwash in daily life for the past 2 weeks
- •Patients who are not taking any medications which may influenced the pattern of oral ulceration
- •Patients who are willing and able to cooperate with all aspects of the protocol and able to communicate effectively and give informed written consent from parents if patients are younger than 18 years old
排除标准
- •Cigarette smoking
- •History of hypersensitivity or allergy to turmeric or other ingredients of mouthwash
- •History of oral mucosal lesions and skin diseases
- •Oral ulceration or inflammation with unknown etiology
- •Pregnant or lactating women
研究组 & 干预措施
Curcumin mouthwash
The curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent.
干预措施: Curcumin mouthwash (Drug)
Placebo mouthwash
The placebo mouthwash contains water, xylitol, and food coloring agent.
干预措施: Placebo mouthwash (Drug)
结局指标
主要结局
Incidence of traumatic ulcer
时间窗: 28 days
The question in Google Form will ask about the number of traumatic ulcers that can be obviously seen in the mouth. The examiner will provide a picture of traumatic ulcer in the first visit. The participant will be requested to closely check on their mouth starting from reversing the upper and lower lips, then inspect the inner surface of lip and gingiva. Second, move buccal mucosa away from the teeth and gingiva, then, examine one side to the other. The participant will be requested to mark the site of traumatic ulcers on the simple diagram of oral cavity which is divided into 6 area per arch (Right molar teeth, right premolar teeth, right anterior teeth, left molar teeth, left premolar teeth, left anterior teeth). The incidence will be recorded dichotomously (presence or absence of traumatic ulcers).
Duration of each ulcer until it heals
时间窗: 28 days
A period between the first day that traumatic ulcer can be seen unit it resolves. As the participant will be requested to record number of ulcers and locate the sites every day. Duration will be calculated at the end of trial
次要结局
- Pain score(28 days)
- Comments of adverse effect (if any)(28 days)
- Use of orthodontic wax(28 days)
- Comments of any suggestions(28 days)
- The site of traumatic ulcer(28 days)
- Comments of participant's satisfaction(28 days)
研究者
Supaporn Suttamanatwong, D.D.S., Ph.D
Department of Physiology, Faculty of Dentistry, Chulalongkorn University
Chulalongkorn University