Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances

Chulalongkorn University

Status and phase: Completed; Early Phase 1

Conditions: Orthodontic Appliances, Fixed; Oral Ulcer

Treatments: Drug: Curcumin mouthwash; Drug: Placebo mouthwash

Study type: Interventional

Funder types: Other

Identifiers

NCT05147376

HREC-DCU 2021-044

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 70 patients

Sex: All

Ages: 12 to 30 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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70 participants in 2 patient groups

Curcumin mouthwash

Experimental group

Description:

The curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent.

Treatment:

Drug: Curcumin mouthwash

Placebo mouthwash

Sham Comparator group

Description:

The placebo mouthwash contains water, xylitol, and food coloring agent.

Treatment:

Drug: Placebo mouthwash