Status:
COMPLETED
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Lead Sponsor:
Indiana University
Collaborating Sponsors:
Water Pik, Inc.
Delta Dental Foundation
Conditions:
Dental Plaque
Dental Caries
Eligibility:
All Genders
10-25 years
Phase:
PHASE2
Brief Summary
This study aims to investigate the impact of a bromelain pre-rinse adjunct on oral plaque removal in orthodontic subjects. The study's null hypothesis states that there is no statistically significant...
Detailed Description
Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In vitro bromelain...
Eligibility Criteria
Inclusion
- male or female
- 10 to 25 years of age
- willing to consent to participation
- able to follow study instructions
- in active orthodontic treatment with fixed orthodontic appliances
Exclusion
- unwilling/unable to follow study instructions
- documented/suspected pineapple allergy
- proteolytic enzyme allergy
- food dye allergy
- smoker
Key Trial Info
Start Date :
June 14 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 4 2019
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT04512482
Start Date
June 14 2018
End Date
March 4 2019
Last Update
December 3 2020
Active Locations (1)
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1
Indiana University School of Dentistry
Indianapolis, Indiana, United States, 46202