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

April 20, 2017 updated by: Sucharat Limsitthichaikoon, Khon Kaen University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Khon Kaen
      • Maung, Khon Kaen, Thailand, 40002
        • Khon Kaen University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 25 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebol
Placebo
Drug: Placebo
Blank gel
Active Comparator: Anthocynin
Anthocyanin
Drug: Anthocyanin
Anti-inflammation gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Days 0 and 7 after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
VAS Scores Range From 0 (no Pain) to 10 (Severe Pain)
Time Frame: Days 0 and 7 after treatment
Days 0 and 7 after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Sucharat Limsitthichaikoon, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2015

Primary Completion (Actual)

January 1, 2016

Study Completion (Actual)

January 1, 2016

Study Registration Dates

First Submitted

August 22, 2015

First Submitted That Met QC Criteria

August 31, 2015

First Posted (Estimate)

September 1, 2015

Study Record Updates

Last Update Posted (Actual)

August 2, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE582088

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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