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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Oral Ulcer, Orthodontic Appliances, Fixed

Intervention / Treatment
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* Drug: Curcumin mouthwash
* Drug: Placebo mouthwash


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Curcumin mouthwash<br>The curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent. | Drug: Curcumin mouthwash<br>* 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.<br>|
| Sham Comparator: Placebo mouthwash<br>The placebo mouthwash contains water, xylitol, and food coloring agent. | Drug: Placebo mouthwash<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain score | The pain score will be evaluated by participant based on visual analog scale . The participant will be asked to select a number on the scale that describe the most of their pain and record the state number between 0-100. A higher score represents greater pain intensity | 28 days | 
| The site of traumatic ulcer | The participants will be requested to mark the site of any ulcer on simple diagram of oral cavity which is represented by a number on each of the divided 6 area of buccal mucosa per arch, the most common area of traumatic ulcer (Right molar teeth, right premolar teeth, right anterior teeth, left molar teeth, left premolar teeth, left anterior teeth). | 28 days | 
| Use of orthodontic wax | The participants will be asked to mark the site of using orthodontic wax on a simple diagram of oral cavity which is represented by a number on each of the divided 6 area per arch (Right molar teeth, right premolar teeth, right anterior teeth, left molar teeth, left premolar teeth, left anterior teeth). | 28 days | 
| Comments of adverse effect (if any) | The participants will be asked to record in Google Form daily for any complaint of discomfort from using mouthwash. | 28 days | 
| Comments of participant's satisfaction | At the end of the clinical trial, the participants will be asked to record for levels of satisfaction in mouthwash. The score will be numbered from very satisfied at score 5, satisfied at score 4, neutral or OK at score 3, dissatisfied at score 2, and very dissatisfied at score 1. | 28 days | 
| Comments of any suggestions | At the end of the clinical trial, the participants will be asked to record for any suggestions and comments about the trial or mouthwash. | 28 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Curcumin, Curcumin mouthwash, Traumatic ulcers, Fixed orthodontic appliances