NCT02536781

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
70

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Aug 2015

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

August 22, 2015

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2016

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

August 2, 2017

Completed
Last Updated

August 2, 2017

Status Verified

April 1, 2017

Enrollment Period

5 months

First QC Date

August 22, 2015

Results QC Date

March 1, 2016

Last Update Submit

April 20, 2017

Conditions

Inflammation of MouthAcute Mucous Inflammation

Keywords

AnthocyaninInflammationOrthodontic treatment

Outcome Measures

Primary Outcomes (1)

  • Wound Size (mm^2) Reduction

    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 Outcomes (1)

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

    Days 0 and 7 after treatment

Study Arms (2)

Placebol

PLACEBO COMPARATOR

Placebo

Drug: Placebo

Anthocynin

ACTIVE COMPARATOR

Anthocyanin

Drug: Anthocyanin

Interventions

AnthocyaninDRUG

Anti-inflammation gel

Anthocynin
PlaceboDRUG

Blank gel

Placebol

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • \- 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Khon Kaen University

Maung, Changwat Khon Kaen, 40002, Thailand

Location

Related Publications (2)

  • 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.

    PMID: 19733615RESULT

  • 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.

    PMID: 18413833RESULT

MeSH Terms

Conditions

StomatitisInflammation

Interventions

Anthocyanins

Condition Hierarchy (Ancestors)

Mouth DiseasesStomatognathic DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

FlavonoidsChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingGlycosidesCarbohydratesPigments, BiologicalBiological Factors

Results Point of Contact

Title
Faculty of Pharmaceutical Science
Organization
Khon Kaen University
lsucharat@gmail.com
+66-43-362092

Study Officials

  • Sucharat Limsitthichaikoon

    Khon Kaen University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Pharmaceutical Technology

Study Record Dates

First Submitted

August 22, 2015

First Posted

September 1, 2015

Study Start

August 1, 2015

Primary Completion

January 1, 2016

Study Completion

January 1, 2016

Last Updated

August 2, 2017

Results First Posted

August 2, 2017

Record last verified: 2017-04

Locations

TH(1)