Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Dental Plaque, Dental Caries
About this trial
This is an interventional supportive care trial for Dental Plaque focused on measuring proteolytic enzyme, plaque removal, oral hygiene, orthodontic treatment
Eligibility Criteria
Inclusion Criteria:
- 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 Criteria:
- unwilling/unable to follow study instructions
- documented/suspected pineapple allergy
- proteolytic enzyme allergy
- food dye allergy
- smoker
Sites / Locations
- Indiana University School of Dentistry
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
Experimental: Bromelain, Then Placebo
Experimental: Placebo, Then Bromelain
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of bromelain that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained. After a 1 week washout period, they received the placebo rinse (powdered sugar), following the same protocol and series of intraoral photographs.
Subjects were asked to chew a disclosing tablet, swish, and expectorate. Intraoral photographs were obtained. They then received a vial containing 1 gram of powdered sugar that was reconstituted with 15ml of pineapple juice at 50 degrees F. Subjects swished the solution in their mouth for 2 minutes and then expectorated. Intraoral photographs were obtained. Subjects then received a toothbrush and were asked to brush their teeth for 2 minutes. Intraoral photographs were obtained. The subjects were then given a Waterpik and instructed to use the appliances to clean their teeth and brackets to the best of their ability, for 2 minutes. Intraoral photographs were obtained. After a 1 week washout period, they received the bromelain rinse, following the same protocol and series of intraoral photographs.