MedTrace Logo

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

NCT04512482 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2020-12-03

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • Water Pik, Inc.

    collaborator INDUSTRY

  • Delta Dental Foundation

    collaborator OTHER

  • Indiana University

    lead OTHER

Principal Investigators

  • Kelton Stewart, DDS, MS · Indiana University

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
10 Years
Max Age
25 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-06-14
Primary Completion
2018-07-24
Completion
2019-03-04
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04512482 on ClinicalTrials.gov