Clinical trial NCT05147376: Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
Official title: Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Oral Ulcer
Orthodontic Appliances, Fixed
Keywords: Curcumin
Curcumin mouthwash
Traumatic ulcers
Fixed orthodontic appliances
Lead sponsor: Chulalongkorn University
Sponsor class: OTHER
First posted: 2021-12-07
Enrollment: 70
Sex: ALL
Minimum age (years): 12
Maximum age (years): 30
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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

Primary outcomes:
measure: Incidence of traumatic ulcer
timeFrame: 28 days
measure: Duration of each ulcer until it heals
timeFrame: 28 days
Secondary outcomes:
measure: Pain score
timeFrame: 28 days
measure: The site of traumatic ulcer
timeFrame: 28 days
measure: Use of orthodontic wax
timeFrame: 28 days
measure: Comments of adverse effect (if any)
timeFrame: 28 days
measure: Comments of participant's satisfaction
timeFrame: 28 days
measure: Comments of any suggestions
timeFrame: 28 days
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Department of Pediatric Dentistry, Postgraduate dental clinic, Faculty of Dentistry, Chulalongkorn University
Study officials:
affiliation: Department of Physiology, Faculty of Dentistry, Chulalongkorn University
name: Supaporn Suttamanatwong, D.D.S.,Ph.D.
role: PRINCIPAL_INVESTIGATOR
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