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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04512482
• Other study ID #: 1802369383
• Status: Completed
• Phase: Phase 2
• Start date: June 14, 2018
• Est. completion date: March 4, 2019

Study information

• Verified date: November 2020
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: March 4, 2019
• Est. primary completion date: July 24, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 10 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Plaque

Intervention

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.

Locations

Country	Name	City	State
United States	Indiana University School of Dentistry	Indianapolis	Indiana

Sponsors (3)

Lead Sponsor	Collaborator
Indiana University	Delta Dental Foundation, Water Pik, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1 day