Oral UlcerEarly Phase 1NCT05147376
Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances
A Early Phase 1 study testing Curcumin mouthwash in people with Oral Ulcer and Orthodontic Appliances, Fixed, run by Chulalongkorn University at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 12 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Ulcer, Orthodontic Appliances, Fixed
- What is being tested?
- Curcumin mouthwash
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- 21 Feb 2022to 7 Aug 2023
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 30 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Department of Pediatric Dentistry, Postgraduate dental clinic, Faculty of Dentistry, Chulalongkorn University
Bangkok, 10330
About this study
Official title: Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial
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.
Read the 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
- Being tested
- Curcumin mouthwash, Placebo mouthwash
- Keywords
- Curcumin, Curcumin mouthwash, Traumatic ulcers, Fixed orthodontic appliances
- Medical subject headings
- Oral Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Curcumin mouthwashDrug
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 mouthwashDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Curcumin mouthwash | Experimental | The curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent. Receives: Drug: Curcumin mouthwash |
| Placebo mouthwash | Sham comparator | The placebo mouthwash contains water, xylitol, and food coloring agent. Receives: Drug: Placebo mouthwash |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
Measured: 28 days
Secondary outcomes (6)
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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2021
- Study start21 Feb 2022
- Primary completion7 Aug 2023
- Study completion7 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (44)Papers the sponsor has linked to this study.
- Other trials for Oral UlcerStudies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Supaporn Suttamanatwong, D.D.S., Ph.D, Chulalongkorn University
- Investigators
- Supaporn Suttamanatwong, D.D.S.,Ph.D., Principal investigator, Department of Physiology, Faculty of Dentistry, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05147376
- Sponsor's protocol ID
- HREC-DCU 2021-044
- Status last verified
- Sep 2023
- First submitted
- 24 Nov 2021
- Last updated
- 21 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25200875Baricevic 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.
PubMed 21121986Chattopadhyay I, Biswas K, Bandyopadhyay U, Banerjee RK. Turmeric and curcumin: Biological actions and medicinal applications. CURRENT SCIENCE-BANGALORE-. 2004;87:44-53.
Duggi S, Handral H, Handral R, G T, Sd DS. Turmeric: Nature's precious medicine. Asian Journal of Pharmaceutical and Clinical Research. 2013;6:10-6.
Emiroglu G, Ozergin Coskun Z, Kalkan Y, Celebi Erdivanli O, Tumkaya L, Terzi S, Ozgur A, Demirci M, Dursun E. The Effects of Curcumin on Wound Healing in a Rat Model of Nasal Mucosal Trauma. Evid Based Complement Alternat Med. 2017;2017:9452392. doi: 10.1155/2017/9452392. Epub 2017 Sep 5.
PubMed 29018487Fitzpatrick SG, Cohen DM, Clark AN. Ulcerated Lesions of the Oral Mucosa: Clinical and Histologic Review. Head Neck Pathol. 2019 Mar;13(1):91-102. doi: 10.1007/s12105-018-0981-8. Epub 2019 Mar 7.
PubMed 30701449Jurenka JS. Anti-inflammatory properties of curcumin, a major constituent of Curcuma longa: a review of preclinical and clinical research. Altern Med Rev. 2009 Jun;14(2):141-53.
PubMed 19594223Khan RMS, Hassan KR, Rizwan M, Ashraf J. Prevalence and type of oral mucosal lesions in patients with fixed orthodontic appliances. Medical Forum Monthly. 2016;27:12-5.
Lau P, Wong R, editors. Risks and complications in orthodontic treatment, 2006.
Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
PubMed 5237684LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
PubMed 14121956Mahattanadul S, Mustafa MW, Kuadkaew S, Pattharachayakul S, Ungphaiboon S, Sawanyawisuth K. Oral ulcer healing and anti-Candida efficacy of an alcohol-free chitosan-curcumin mouthwash. Eur Rev Med Pharmacol Sci. 2018 Oct;22(20):7020-7023. doi: 10.26355/eurrev_201810_16173.
PubMed 30402869McHugh ML. Interrater reliability: the kappa statistic. Biochem Med (Zagreb). 2012;22(3):276-82.
PubMed 23092060Mohanty C, Sahoo SK. Curcumin and its topical formulations for wound healing applications. Drug Discov Today. 2017 Oct;22(10):1582-1592. doi: 10.1016/j.drudis.2017.07.001. Epub 2017 Jul 12.
PubMed 28711364Mondal S, Ghosh S, Moulik SP. Stability of curcumin in different solvent and solution media: UV-visible and steady-state fluorescence spectral study. J Photochem Photobiol B. 2016 May;158:212-8. doi: 10.1016/j.jphotobiol.2016.03.004. Epub 2016 Mar 6.
PubMed 26985735
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a Curcumin Mouthwash in Preventing Traumatic Ulcers in Patients With Fixed Orthodontic Appliances: a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05147376
- Acronym / sponsor ID
- HREC-DCU 2021-044
- Conditions
- Oral Ulcer, Orthodontic Appliances, Fixed
- Keywords
- Curcumin, Curcumin mouthwash, Traumatic ulcers, Fixed orthodontic appliances
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Study start
- 21 Feb 2022 (actual)
- Primary completion
- 7 Aug 2023 (actual)
- Study completion
- 7 Aug 2023 (actual)
- First posted
- 7 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Curcumin mouthwash | Experimental | Drug: Curcumin mouthwashThe curcumin mouthwash contains the final concentration of 1 μM curcumin, water, xylitol, and food coloring agent. |
| Placebo mouthwash | Sham comparator | Drug: Placebo mouthwashThe placebo mouthwash contains water, xylitol, and food coloring agent. |
Who may qualify
- Ages
- 12 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Curcumin mouthwashRinse 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. | Drug | Curcumin mouthwash |
| Placebo mouthwashRinse 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. | Drug | Placebo mouthwash |
Primary outcome
Incidence of traumatic ulcer
Time frame: 28 days
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).
Duration of each ulcer until it heals
Time frame: 28 days
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
6 secondary outcomes
Pain score
Time frame: 28 days
The site of traumatic ulcer
Time frame: 28 days
Use of orthodontic wax
Time frame: 28 days
Comments of adverse effect (if any)
Time frame: 28 days
Comments of participant's satisfaction
Time frame: 28 days
Comments of any suggestions
Time frame: 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Sep 2023.
- Background: PubMed 25200875Akbik 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.
- Background: PubMed 21121986Baricevic 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.
- BackgroundChattopadhyay I, Biswas K, Bandyopadhyay U, Banerjee RK. Turmeric and curcumin: Biological actions and medicinal applications. CURRENT SCIENCE-BANGALORE-. 2004;87:44-53.
- BackgroundDuggi S, Handral H, Handral R, G T, Sd DS. Turmeric: Nature's precious medicine. Asian Journal of Pharmaceutical and Clinical Research. 2013;6:10-6.
- Background: PubMed 29018487Emiroglu G, Ozergin Coskun Z, Kalkan Y, Celebi Erdivanli O, Tumkaya L, Terzi S, Ozgur A, Demirci M, Dursun E. The Effects of Curcumin on Wound Healing in a Rat Model of Nasal Mucosal Trauma. Evid Based Complement Alternat Med. 2017;2017:9452392. doi: 10.1155/2017/9452392. Epub 2017 Sep 5.
- Background: PubMed 30701449Fitzpatrick SG, Cohen DM, Clark AN. Ulcerated Lesions of the Oral Mucosa: Clinical and Histologic Review. Head Neck Pathol. 2019 Mar;13(1):91-102. doi: 10.1007/s12105-018-0981-8. Epub 2019 Mar 7.
- Background: PubMed 19594223Jurenka JS. Anti-inflammatory properties of curcumin, a major constituent of Curcuma longa: a review of preclinical and clinical research. Altern Med Rev. 2009 Jun;14(2):141-53.
- BackgroundKhan RMS, Hassan KR, Rizwan M, Ashraf J. Prevalence and type of oral mucosal lesions in patients with fixed orthodontic appliances. Medical Forum Monthly. 2016;27:12-5.
- BackgroundLau P, Wong R, editors. Risks and complications in orthodontic treatment, 2006.
- Background: PubMed 5237684Loe H. The Gingival Index, the Plaque Index and the Retention Index Systems. J Periodontol. 1967 Nov-Dec;38(6):Suppl:610-6. doi: 10.1902/jop.1967.38.6.610. No abstract available.
- Background: PubMed 14121956LOE H, SILNESS J. PERIODONTAL DISEASE IN PREGNANCY. I. PREVALENCE AND SEVERITY. Acta Odontol Scand. 1963 Dec;21:533-51. doi: 10.3109/00016356309011240. No abstract available.
- Background: PubMed 30402869Mahattanadul S, Mustafa MW, Kuadkaew S, Pattharachayakul S, Ungphaiboon S, Sawanyawisuth K. Oral ulcer healing and anti-Candida efficacy of an alcohol-free chitosan-curcumin mouthwash. Eur Rev Med Pharmacol Sci. 2018 Oct;22(20):7020-7023. doi: 10.26355/eurrev_201810_16173.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Supaporn Suttamanatwong, D.D.S.,Ph.D. principal investigator
Department of Physiology, Faculty of Dentistry, Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Curcumin mouthwash in people with Oral Ulcer and Orthodontic Appliances, Fixed, run by Chulalongkorn University at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of traumatic ulcer (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05147376, which also lists 44 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Sep 2023.