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

NCT04512482 | Completed Phase 2 Results FDA Drug

• 1 other identifier: 1802369383
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Plaque; Dental Caries

Keywords

proteolytic enzyme; plaque removal; oral hygiene; orthodontic treatment

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Experimental: Bromelain, Then Placebo

EXPERIMENTAL

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.

Drug: Bromelain; Other: Powdered sugar

Experimental: Placebo, Then Bromelain

PLACEBO COMPARATOR

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.

Drug: Bromelain; Other: Powdered sugar

Interventions

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.

Also known as: proteolytic enzyme rinse

Experimental: Bromelain, Then Placebo; Experimental: Placebo, Then Bromelain

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.

Also known as: placebo rinse

Experimental: Bromelain, Then Placebo; Experimental: Placebo, Then Bromelain

Eligibility Criteria

• Age: 10 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• male or female
• to 25 years of age
• willing to consent to participation
• able to follow study instructions
• in active orthodontic treatment with fixed orthodontic appliances

You may not qualify if:

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

Sponsors & Collaborators

• Indiana University: lead
• Water Pik, Inc.: collaborator
• Delta Dental Foundation: collaborator

Study Sites (1)

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Location

MeSH Terms

Conditions

Dental Plaque; Dental Caries

Interventions

Bromelains

Condition Hierarchy (Ancestors)

Dental Deposits; Tooth Diseases; Stomatognathic Diseases; Tooth Demineralization

Intervention Hierarchy (Ancestors)

Cysteine Endopeptidases; Cysteine Proteases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Endopeptidases

Results Point of Contact

• Title: Kelton T. Stewart, Department Chair
• Organization: Indiana University School of Dentistry, Department of Orthodontics

keltstew@iu.edu

317-278-1087

Study Officials

• Kelton Stewart, DDS, MS

  Indiana University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Investigators were blinded during the clinical phase of the study and were unaware of the agents the subjects received. The investigators were also blinded during the visual plaque score analysis of the project and were unaware of what photograph corresponded to what phase or intervention.
• Purpose: SUPPORTIVE CARE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair & Program Director, Department of Orthodontics and

Model Details: Enrolled subjects undergoing orthodontic treatment with fixed appliances will be randomized to receive either the Bromelain rinse or Placebo first and then will be crossed over to receive the opposite intervention. The study will consist of two treatment period (1 day) separated by a washout period of 1 week.

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: August 13, 2020
• Study Start: June 14, 2018
• Primary Completion: July 24, 2018
• Study Completion: March 4, 2019
• Last Updated: December 3, 2020
• Results First Posted: December 3, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)