Inflammation of MouthPhase 2/3NCT02536781
Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
A Phase 2/3 study testing Anthocyanin in people with Inflammation of Mouth and Acute Mucous Inflammation, run by Khon Kaen University at 1 site in Thailand.
Trial summary
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Inflammation of Mouth, Acute Mucous Inflammation
- What is being tested?
- Anthocyanin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- 1 siteThailand
- Study dates
- Aug 2015to Jan 2016
- Phase
- Phase 2/3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and/or females between the ages of 18 and 35 with oral inflammation, investigated by a dentist, caused by orthodontic devices.
- The inflammatory lesions are occurred at labial and/or buccal mucosa.
- Be able to communicate well with the investigator and to comply with the requirements of the entire study.
- Not participate in other project(s).
- Be willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
Who cannot join
- - Have the persistent inflammatory lesions and/or ulcers that cannot be healed more than 2 weeks or the inflammation that may lead to be oral cancer.
- Have severe oral inflammation or the inflammation occur from ongoing head and neck chemotherapy or serious oral inflammatory such as periodontitis and oral lichen planus.
- Taking steroid or applying topical steroid within or 7 days before participated in this study.
- Have a history of allergy or hypersensitivity to any red, blue, or purple color fruits and vegetables such as berry groups.
- Patients with auto-immune diseases or diseases that related to wound healing process such as diabetes.
- Patients that cannot meet the follow up or drop out of the experiments.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Khon Kaen University Ethics Committee in Human Research
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
Read the detailed description
Multiple inflammatory lesions caused from orthodontic treatments are commonly found in these patients and the irritations from the insertion of the orthodontic wire are hard to apply the topical cream or gel. Standard treatment to prevent oral mucosal irritation caused from orthodontic brackets and wires is an orthodontic wax to cover the appliances. However, the covering wax is just a prophylactic measure to protect the mucosal irritation. Thus, the patients still need a specific treatment for their oral inflammatory condition. Developing a product that can treat entire inflammatory areas in oral cavity, promote oral hygiene, and anti-fungal would be beneficial and useful for the orthodontic treatment. Anthocyanins, one of a natural compound from red, blue, purple vegetables, fruits, and flowers, have many beneficial effects including anti-inflammation and the most important effect superior to steroid usage is anti-candidiasis. Interesting in anthocyanins as the natural treatment, has drawn attention due to the benefits in oral inflammation. Previous study on the effect of a topical anthocyanin gel demonstrated positive effect of topical anthocyanins gel against oral inflammation in human subjects at 6 weeks. Unfortunately, anthocyanin is not stable and easily to be degraded. Therefore, stabilized anthocyanin oral formulation needs to be developed and the formulation needs to provide stable and active anthocyanins in suitable oral formula. This study aims to prepare and investigate effects of anthocyanin complex in order to formulate the mouthrinse for anti-inflammation caused by orthodontic treatment. Thus, to prepare and investigate the effects of anthocyanin activities after forming complexation in order to formulate the mouthrinse would be evaluated. In addition, the examination of anti-oral inflammation caused by orthodontic treatment by anthocyanin complex in clinical trial will be conducted.
- Conditions
- Inflammation of Mouth, Acute Mucous Inflammation
- Being tested
- Anthocyanin, Placebo
- Keywords
- Anthocyanin, Inflammation, Orthodontic treatment
- Medical subject headings
- Stomatitis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AnthocyaninDrug
Anti-inflammation gel
PlaceboDrug
Blank gel
| Study group | Role | What they receive |
|---|---|---|
| Placebol | Placebo comparator | Placebo Receives: Drug: Placebo |
| Anthocynin | Active comparator | Anthocyanin Receives: Drug: Anthocyanin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wound Size (mm^2) Reduction
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
Measured: Days 0 and 7 after treatment
Secondary outcomes (1)
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
Measured: Days 0 and 7 after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study startAug 2015
- Primary completionJan 2016
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Inflammation of MouthStudies of the same condition, open and under way.
- 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
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sucharat Limsitthichaikoon, Khon Kaen University
- Investigators
- Sucharat Limsitthichaikoon, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02536781
- Sponsor's protocol ID
- HE582088
- Status last verified
- Apr 2017
- First submitted
- 22 Aug 2015
- Last updated
- 2 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Nizamutdinova IT, Kim YM, Chung JI, Shin SC, Jeong YK, Seo HG, Lee JH, Chang KC, Kim HJ. Anthocyanins from black soybean seed coats stimulate wound healing in fibroblasts and keratinocytes and prevent inflammation in endothelial cells. Food Chem Toxicol. 2009 Nov;47(11):2806-12. doi: 10.1016/j.fct.2009.08.016. Epub 2009 Sep 4.
PubMed 19733615Shumway BS, Kresty LA, Larsen PE, Zwick JC, Lu B, Fields HW, Mumper RJ, Stoner GD, Mallery SR. Effects of a topically applied bioadhesive berry gel on loss of heterozygosity indices in premalignant oral lesions. Clin Cancer Res. 2008 Apr 15;14(8):2421-30. doi: 10.1158/1078-0432.CCR-07-4096.
PubMed 18413833
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Khon Kaen University Ethics Committee in Human Research
- ClinicalTrials.gov ID
- NCT02536781
- Acronym / sponsor ID
- HE582088
- Conditions
- Inflammation of Mouth, Acute Mucous Inflammation
- Keywords
- Anthocyanin, Inflammation, Orthodontic treatment
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- Aug 2015
- Primary completion
- Jan 2016 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 1 Sep 2015 (estimated)
- Results
- Posted 2 Aug 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
Detailed description
Multiple inflammatory lesions caused from orthodontic treatments are commonly found in these patients and the irritations from the insertion of the orthodontic wire are hard to apply the topical cream or gel. Standard treatment to prevent oral mucosal irritation caused from orthodontic brackets and wires is an orthodontic wax to cover the appliances. However, the covering wax is just a prophylactic measure to protect the mucosal irritation. Thus, the patients still need a specific treatment for their oral inflammatory condition. Developing a product that can treat entire inflammatory areas in oral cavity, promote oral hygiene, and anti-fungal would be beneficial and useful for the orthodontic treatment. Anthocyanins, one of a natural compound from red, blue, purple vegetables, fruits, and flowers, have many beneficial effects including anti-inflammation and the most important effect superior to steroid usage is anti-candidiasis. Interesting in anthocyanins as the natural treatment, has drawn attention due to the benefits in oral inflammation. Previous study on the effect of a topical anthocyanin gel demonstrated positive effect of topical anthocyanins gel against oral inflammation in human subjects at 6 weeks. Unfortunately, anthocyanin is not stable and easily to be degraded. Therefore, stabilized anthocyanin oral formulation needs to be developed and the formulation needs to provide stable and active anthocyanins in suitable oral formula. This study aims to prepare and investigate effects of anthocyanin complex in order to formulate the mouthrinse for anti-inflammation caused by orthodontic treatment. Thus, to prepare and investigate the effects of anthocyanin activities after forming complexation in order to formulate the mouthrinse would be evaluated. In addition, the examination of anti-oral inflammation caused by orthodontic treatment by anthocyanin complex in clinical trial will be conducted.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebol | Placebo comparator | Drug: PlaceboPlacebo |
| Anthocynin | Active comparator | Drug: AnthocyaninAnthocyanin |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male and/or females between the ages of 18 and 35 with oral inflammation, investigated by a dentist, caused by orthodontic devices.
- The inflammatory lesions are occurred at labial and/or buccal mucosa.
- Be able to communicate well with the investigator and to comply with the requirements of the entire study.
- Not participate in other project(s).
- Be willingness to give written informed consent (prior to any study-related procedures being performed) and to be able to adhere to the study restrictions and examination schedule.
Key exclusion criteria (6 listed)
- - Have the persistent inflammatory lesions and/or ulcers that cannot be healed more than 2 weeks or the inflammation that may lead to be oral cancer.
- Have severe oral inflammation or the inflammation occur from ongoing head and neck chemotherapy or serious oral inflammatory such as periodontitis and oral lichen planus.
- Taking steroid or applying topical steroid within or 7 days before participated in this study.
- Have a history of allergy or hypersensitivity to any red, blue, or purple color fruits and vegetables such as berry groups.
- Patients with auto-immune diseases or diseases that related to wound healing process such as diabetes.
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 |
|---|---|---|
| AnthocyaninAnti-inflammation gel | Drug | Anthocynin |
| PlaceboBlank gel | Drug | Placebol |
Primary outcome
Wound Size (mm^2) Reduction
Time frame: Days 0 and 7 after treatment
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
1 secondary outcome
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
Time frame: Days 0 and 7 after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 19733615Nizamutdinova IT, Kim YM, Chung JI, Shin SC, Jeong YK, Seo HG, Lee JH, Chang KC, Kim HJ. Anthocyanins from black soybean seed coats stimulate wound healing in fibroblasts and keratinocytes and prevent inflammation in endothelial cells. Food Chem Toxicol. 2009 Nov;47(11):2806-12. doi: 10.1016/j.fct.2009.08.016. Epub 2009 Sep 4.
- Results publication: PubMed 18413833Shumway BS, Kresty LA, Larsen PE, Zwick JC, Lu B, Fields HW, Mumper RJ, Stoner GD, Mallery SR. Effects of a topically applied bioadhesive berry gel on loss of heterozygosity indices in premalignant oral lesions. Clin Cancer Res. 2008 Apr 15;14(8):2421-30. doi: 10.1158/1078-0432.CCR-07-4096.
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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.
Sucharat Limsitthichaikoon principal investigator
Khon Kaen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Anthocyanin in people with Inflammation of Mouth and Acute Mucous Inflammation, run by Khon Kaen 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 5 inclusion and 6 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 2 Aug 2017. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Aug 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Wound Size (mm^2) Reduction (time frame: Days 0 and 7 after treatment). 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 NCT02536781, which also lists 2 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 2 Aug 2017.