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.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

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.

What they're measuring

Incidence of traumatic ulcer

Timeframe: 28 days

Duration of each ulcer until it heals

Timeframe: 28 days

Trial details

NCT IDNCT05147376

SponsorChulalongkorn University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-08-07

View on ClinicalTrials.gov More Oral Ulcer trials

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.