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Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment

Primary Purpose

Inflammation of Mouth, Acute Mucous Inflammation

Status
Completed
Phase
Phase 2
Locations
Thailand
Study Type
Interventional
Intervention
Anthocyanin
Placebo
Sponsored by
Khon Kaen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammation of Mouth focused on measuring Anthocyanin, Inflammation, Orthodontic treatment

Eligibility Criteria

18 Years - 25 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Khon Kaen University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebol

Anthocynin

Arm Description

Placebo

Anthocyanin

Outcomes

Primary Outcome Measures

Wound Size (mm^2) Reduction
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment

Secondary Outcome Measures

VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)

Full Information

First Posted
August 22, 2015
Last Updated
April 20, 2017
Sponsor
Khon Kaen University
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1. Study Identification

Unique Protocol Identification Number
NCT02536781
Brief Title
Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment
Official Title
Khon Kaen University Ethics Committee in Human Research
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
January 2016 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Khon Kaen University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation of Mouth, Acute Mucous Inflammation
Keywords
Anthocyanin, Inflammation, Orthodontic treatment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebol
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
Anthocynin
Arm Type
Active Comparator
Arm Description
Anthocyanin
Intervention Type
Drug
Intervention Name(s)
Anthocyanin
Intervention Description
Anti-inflammation gel
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Blank gel
Primary Outcome Measure Information:
Title
Wound Size (mm^2) Reduction
Description
Comparing between the active and placebo about the wound size reduction from day 0 to day 7 after treatment
Time Frame
Days 0 and 7 after treatment
Secondary Outcome Measure Information:
Title
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
Time Frame
Days 0 and 7 after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sucharat Limsitthichaikoon
Organizational Affiliation
Khon Kaen University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Khon Kaen University
City
Maung
State/Province
Khon Kaen
ZIP/Postal Code
40002
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
19733615
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.
Results Reference
result
PubMed Identifier
18413833
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.
Results Reference
result

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Efficacy of Anthocyanin Mouthrinse for Oral Anti-inflammation From Orthodontic Treatment

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