NCT04512482

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 10 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Dental Plaque
• Dental Caries

Interventions

Type	Name	Description
DRUG	Bromelain	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	Powdered sugar	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.

Timeline

• Start date: 2018-06-14
• Primary completion: 2018-07-24
• Completion: 2019-03-04
• First posted: 2020-08-13
• Last updated: 2020-12-03
• Results posted: 2020-12-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study