Phase 3
N=70
Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
Inflammation of Mouth · Acute Mucous Inflammation
Bottom Line
View on ClinicalTrials.gov: NCT02536781 ↗Enrolled (actual)
70
Serious AEs
0.0%
Results posted
Aug 2017
Primary outcome: Primary: Wound Size (mm^2) Reduction — 11.26; 8.92 mm^2
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Anthocyanin (Drug); Placebo (Drug)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Khon Kaen University
- Primary completion
- Jan 2016
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 | — |
Summary
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
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). 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.