Phase 3
Completed N=70
Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
Inflammation of Mouth · Acute Mucous Inflammation
Source: ClinicalTrials.gov NCT02536781 ↗
Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcomePrimary: Wound Size (mm^2) Reduction — 11.26; 8.92 mm^2
◆ Published Evidence
Highly cited
120citations · ~7 / year
Anthocyanins from black soybean seed coats stimulate wound healing in fibroblasts and keratinocytes and prevent inflammation in endothelial cells.
Summary
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
Linked Publications (2)
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Anthocyanins from black soybean seed coats stimulate wound healing in fibroblasts and keratinocytes and prevent inflammation in endothelial cells.
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Effects of a topically applied bioadhesive berry gel on loss of heterozygosity indices in premalignant oral lesions.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Wound Size (mm^2) Reduction |
11.26; 8.92 | — |
| SECONDARY VAS Scores Range From 0 (no Pain) to 10 (Severe Pain) |
1.53; 0.96 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- - 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.
Data sourced from ClinicalTrials.gov (NCT02536781) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.