NCT05147376

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

Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial

• Status: Completed
• Phase: EARLY_Phase 1
• Study type: Interventional
• Enrollment: 70 (actual)
• Sponsor: Chulalongkorn University · Academic / Other
• Sex: All
• Age: 12 Years – 30 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Oral Ulcer
• Orthodontic Appliances, Fixed

Interventions

Type	Name	Description
DRUG	Curcumin mouthwash	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.
DRUG	Placebo mouthwash	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.

Timeline

• Start date: 2022-02-21
• Primary completion: 2023-08-07
• Completion: 2023-08-07
• First posted: 2021-12-07
• Last updated: 2023-09-21

Locations

1 site across 1 country: Thailand