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

NCT05147376 | Completed Early Phase 1 DMC

• 1 other identifier: HREC-DCU 2021-044
• Study Type: interventional
• Target: 70
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Ulcer; Orthodontic Appliances, Fixed

Keywords

Curcumin; Curcumin mouthwash; Traumatic ulcers; Fixed orthodontic appliances

Outcome Measures

Primary Outcomes (2)

• Incidence of traumatic ulcer

  The question in Google Form will ask about the number of traumatic ulcers that can be obviously seen in the mouth. The examiner will provide a picture of traumatic ulcer in the first visit. The participant will be requested to closely check on their mouth starting from reversing the upper and lower lips, then inspect the inner surface of lip and gingiva. Second, move buccal mucosa away from the teeth and gingiva, then, examine one side to the other. The participant will be requested to mark the site of traumatic ulcers on the simple diagram of oral cavity which is divided into 6 area per arch (Right molar teeth, right premolar teeth, right anterior teeth, left molar teeth, left premolar teeth, left anterior teeth). The incidence will be recorded dichotomously (presence or absence of traumatic ulcers).

  28 days

• Duration of each ulcer until it heals

  A period between the first day that traumatic ulcer can be seen unit it resolves. As the participant will be requested to record number of ulcers and locate the sites every day. Duration will be calculated at the end of trial

  28 days

Secondary Outcomes (6)

• Pain score

  28 days

• The site of traumatic ulcer

  28 days

• Use of orthodontic wax

  28 days

• Comments of adverse effect (if any)

  28 days

• Comments of participant's satisfaction

  28 days

Study Arms (2)

Curcumin mouthwash

EXPERIMENTAL

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

Drug: Curcumin mouthwash

Placebo mouthwash

SHAM COMPARATOR

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

Drug: Placebo mouthwash

Interventions

Curcumin mouthwash 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.

Curcumin mouthwash

Placebo mouthwash 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

Eligibility Criteria

• Age: 12 Years - 30 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chulalongkorn University: lead

Study Sites (1)

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

Bangkok, 10330, Thailand

Location

Related Publications (44)

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MeSH Terms

Conditions

Oral Ulcer

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases

Study Officials

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

  Department of Physiology, Faculty of Dentistry, Chulalongkorn University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: This clinical trial is a double-blind study that participants and examiner will be blinded to group assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Physiology, Faculty of Dentistry, Chulalongkorn University

Study Record Dates

• First Submitted: November 24, 2021
• First Posted: December 7, 2021
• Study Start: February 21, 2022
• Primary Completion: August 7, 2023
• Study Completion: August 7, 2023
• Last Updated: September 21, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)