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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02536781
Recruitment Status : Completed
First Posted : September 1, 2015
Results First Posted : August 2, 2017
Last Update Posted : August 2, 2017
Information provided by (Responsible Party):
Sucharat Limsitthichaikoon, Khon Kaen University

Brief Summary:
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.

Condition or disease Intervention/treatment Phase
Inflammation of Mouth Acute Mucous Inflammation Drug: Anthocyanin Drug: Placebo Phase 2 Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Khon Kaen University Ethics Committee in Human Research
Study Start Date : August 2015
Actual Primary Completion Date : January 2016
Actual Study Completion Date : January 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Orthodontia

Arm Intervention/treatment
Placebo Comparator: Placebol
Drug: Placebo
Blank gel

Active Comparator: Anthocynin
Drug: Anthocyanin
Anti-inflammation gel

Primary Outcome Measures :
  1. 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

Secondary Outcome Measures :
  1. VAS Scores Range From 0 (no Pain) to 10 (Severe Pain) [ Time Frame: Days 0 and 7 after treatment ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 25 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02536781

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Khon Kaen University
Maung, Khon Kaen, Thailand, 40002
Sponsors and Collaborators
Khon Kaen University
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Principal Investigator: Sucharat Limsitthichaikoon Khon Kaen University
Publications of Results:
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Responsible Party: Sucharat Limsitthichaikoon, Pharmaceutical Technology, Khon Kaen University Identifier: NCT02536781    
Other Study ID Numbers: HE582088
First Posted: September 1, 2015    Key Record Dates
Results First Posted: August 2, 2017
Last Update Posted: August 2, 2017
Last Verified: April 2017
Keywords provided by Sucharat Limsitthichaikoon, Khon Kaen University:
Orthodontic treatment
Additional relevant MeSH terms:
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Pathologic Processes
Gastrointestinal Diseases
Digestive System Diseases
Mouth Diseases
Stomatognathic Diseases