Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse

Phase 2

Completed

• Conditions: Dental Caries; Dental Plaque
• Interventions: Drug: Bromelain; Other: Powdered sugar

• Registration Number: NCT04512482
• Lead Sponsor: Indiana University

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 difference in visual plaque scores among orthodontic subjects with or without proteolytic enzyme rinse aid.

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 study demonstrated antibacterial effect on oral pathogens. Bromelain was found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The impact of bromelain application prior to traditional mechanisms of plaque removal have not been clearly evaluated.

Study Timeline

• Study Start: 2018-06-14
• Primary Completion: 2018-07-24
• Study Completion: 2019-03-04
• Study First Submitted: 2019-07-22
• Study First Submitted QC: 2020-08-11
• Study First Posted: 2020-08-13
• Results First Submitted: 2020-08-22
• Status Verified: 2020-11
• Results First Submitted QC: 2020-11-08
• Last Update Submitted: 2020-11-08
• Results First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 46

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

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Exclusion Criteria

• unwilling/unable to follow study instructions
• documented/suspected pineapple allergy
• proteolytic enzyme allergy
• food dye allergy
• smoker

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Experimental: Bromelain, Then Placebo	Powdered sugar	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.
Experimental: Placebo, Then Bromelain	Powdered sugar	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.
Experimental: Bromelain, Then Placebo	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.
Experimental: Placebo, Then Bromelain	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 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.

Primary Outcome Measures

Name	Time	Method
Composite Plaque Score	1 day	The composite plaque score refers to the cumulative plaque score of all twelve teeth following the administration of the bromelain and placebo (powdered sugar) solutions. The composite plaque score scale had a minimum value of 0 and a maximum value of 48. A score of 0 indicated no plaque was observed on the teeth, while a a score of 48 indicated severe plaque on all possible tooth surfaces. A lower plaque score reflects a better outcome, while a higher plaque score a worse outcome.

Trial Locations

Locations (1)

Indiana University School of Dentistry; 🇺🇸 Indianapolis, Indiana, United States