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

NCT ID: NCT05147376

Last Updated: 2023-09-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: EARLY_PHASE1
• Total Enrollment: 70 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-02-21
• Study Completion Date: 2023-08-07

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Curcumin mouthwash

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

Group Type: EXPERIMENTAL

Curcumin mouthwash

Intervention Type: DRUG

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.

Placebo mouthwash

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

Group Type: SHAM_COMPARATOR

Placebo mouthwash

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 12 Years
• Maximum Eligible Age: 30 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Chulalongkorn University

OTHER

Sponsor Role: lead

Responsible Party

Supaporn Suttamanatwong, D.D.S., Ph.D

Department of Physiology, Faculty of Dentistry, Chulalongkorn University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Supaporn Suttamanatwong, D.D.S.,Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Department of Physiology, Faculty of Dentistry, Chulalongkorn University

Locations

Department of Pediatric Dentistry, Postgraduate dental clinic, Faculty of Dentistry, Chulalongkorn University

Bangkok, , Thailand

Countries

Thailand

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Other Identifiers

HREC-DCU 2021-044

Identifier Type: -

Identifier Source: org_study_id