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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Curcumin mouthwash | Experimental | The curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent. |
|
| Placebo mouthwash | Sham Comparator | The placebo mouthwash contains water, xylitol, and food coloring agent. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Supaporn Suttamanatwong, D.D.S.,Ph.D. | Department of Physiology, Faculty of Dentistry, Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Pediatric Dentistry, Postgraduate dental clinic, Faculty of Dentistry, Chulalongkorn University | Bangkok | 10330 | Thailand |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25200875 | Background | Akbik D, Ghadiri M, Chrzanowski W, Rohanizadeh R. Curcumin as a wound healing agent. Life Sci. 2014 Oct 22;116(1):1-7. doi: 10.1016/j.lfs.2014.08.016. Epub 2014 Sep 6. | |
| 21121986 | Background | Baricevic M, Mravak-Stipetic M, Majstorovic M, Baranovic M, Baricevic D, Loncar B. Oral mucosal lesions during orthodontic treatment. Int J Paediatr Dent. 2011 Mar;21(2):96-102. doi: 10.1111/j.1365-263X.2010.01078.x. Epub 2010 Dec 2. |
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| ID | Term |
|---|---|
| D019226 | Oral Ulcer |
| ID | Term |
|---|---|
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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This clinical trial is a double-blind study that participants and examiner will be blinded to group assignment.
| 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. |
|
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 |
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| 41185016 | Derived | Somprajob C, Auychai P, Chavanavesh J, Suttamanatwong S. Effectiveness of curcumin mouthwash in preventing traumatic ulcers in orthodontic patients. BMC Oral Health. 2025 Nov 3;25(1):1725. doi: 10.1186/s12903-025-07141-5. |