Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Ortho… (NCT05147376) | Clinical Trial Compass
CompletedEarly Phase 1
Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
Thailand70 participantsStarted 2022-02-21
Plain-language summary
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.
Who can participate
Age range
12 Years – 30 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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
Exclusion Criteria:
* 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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial tested a curcumin mouthwash to help prevent mouth ulcers caused by fixed braces — is a curcumin-based rinse something worth trying in my situation, and are there any commercially available options you'd recommend?
2Since this was an early Phase 1 study, what do we actually know so far about how safe and effective curcumin mouthwash is for ulcers from orthodontic appliances, and are there more established treatments I should consider first?
3The trial measured both how often ulcers appeared and how long they took to heal — based on what's been published, did the curcumin mouthwash show meaningful improvement in either of those areas compared to a placebo or standard rinse?
4Given that this trial is now completed, has the results been published anywhere, and would you be able to review the findings with me to help decide if this approach makes sense alongside my orthodontic treatment?
5Are there any interactions or concerns I should know about with curcumin mouthwash if I'm already using other oral care products or taking any medications?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.