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

Indiana University46 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

TRIPLE

Enrollment

Conditions

Dental Plaque Dental Caries

Interventions

BromelainDRUG

The subjects were randomized to either receive the bromelain pre-rinse or the powdered sugar placebo pre-rinse. Subjects then had a 5-9 day washout period and was then exposed to the other intervention.

Powdered sugarOTHER

Eligibility

Sex: ALLMin age: 10 YearsMax age: 25 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

Indiana University School of Dentistry

Indianapolis, Indiana, United States

Outcomes

Primary Outcomes

Composite Plaque Score

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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