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Completed

NCT Number: NCT04512482

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

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.

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Key information

Conditions

Dental Plaque Dental Caries Dental Deposits Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

10 year–25 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Bromelain

Drug

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.

Other names: proteolytic enzyme rinse

Powdered sugar

Other

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.

Other names: placebo rinse

Primary outcomes

  1. Composite Plaque Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indiana University

Other

Collaborators

  • Delta Dental Foundation
  • Water Pik, Inc.

Registry information

Official study title

A Visual Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse in Orthodontic Subjects

Important dates

Study start
2018
Primary completion
2018
Study completion
2019
First posted
Aug 13, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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