Overview

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

Status:
Completed
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
The purpose of this study is to compare the oral inflammatory reduction effect caused from orthodontic treatment of anthocyanin and placebo mouthrinse.
Phase:
Phase 2/Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Khon Kaen University
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.