Status:

UNKNOWN

The Effectiveness and Safety of Mucoadhesive Film Containing A.Oleracea Extract

Lead Sponsor:

Khon Kaen University

Conditions:

Oral Mucosa

Eligibility:

All Genders

18-60 years

Phase:

NA

Brief Summary

Several natural products have been use to promote wound healing and relieve pain. Acmella oleracea has a component that has anesthetic and anti-inflammatory properties. The mucoadhesive film can be i...

Detailed Description

Total 72 Participants will divided into 2 groups by dentist who was not an examiner performed the randomization using blocked randomization (block of 4) from program of https://www.sealedenvelope.com/...

Eligibility Criteria

Inclusion

  • Healthy people age 18-60 years old and do not have regular medication.
  • Able to give the consent formation in a study and to cooperate in answering questionnaires or data records in google formation.
  • The participants must not have any wounds, tattoos, inflammation or pathology on the oral mucosa and skin of testing area.
  • The participants who can come to follow up for a specified period of time.

Exclusion

  • The participants who need dental treatment or necessary to use topical medication to treat oral diseases during the study period (7 days).
  • History of allergic to the components of mucoadhesive film and/or have a history of other allergies.
  • The vulnerable participants include pregnancy or lactating women and disabilities.
  • History of using antihistamines drugs during the one-week period prior to joining the study or participants who need to use such antihistamines during the time participating in the study.
  • History of using topical gluco-corticosteroids during the one-week period on skin testing areas.

Key Trial Info

Start Date :

February 28 2022

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

December 31 2022

Estimated Enrollment :

72 Patients enrolled

Trial Details

Trial ID

NCT05219747

Start Date

February 28 2022

End Date

December 31 2022

Last Update

February 2 2022

Active Locations (1)

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Faculty of Dentistry , Khon Kaen University

Khon Kaen, Thailand, 40002