Clinical trial NCT02536781: Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
Official title: Khon Kaen University Ethics Committee in Human Research
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Inflammation of Mouth
Acute Mucous Inflammation
Keywords: Anthocyanin
Inflammation
Orthodontic treatment
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2015-09-01
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Primary outcomes:
measure: Wound Size (mm^2) Reduction
timeFrame: Days 0 and 7 after treatment
Secondary outcomes:
measure: VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
timeFrame: Days 0 and 7 after treatment
Other outcomes:
Locations:
city: Maung
country: Thailand
facility: Khon Kaen University
state: Khon Kaen
Study officials:
affiliation: Khon Kaen University
name: Sucharat Limsitthichaikoon
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Shumway 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.