CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 46 enrolled
Drug / intervention
Bromelain +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04512482
NCT04512482Phase 2Completed
CompareCT.gov

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

Indiana University·interventional·Posted Aug 13, 2020·Updated Dec 3, 2020

In Brief

A Phase 2 clinical trial evaluating Bromelain and Powdered sugar for Dental Plaque and Dental Caries. Completed, enrolled 46 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDental Plaque, Dental Caries
CountriesUnited States
CollaboratorsWater Pik, Inc., Delta Dental Foundation

Timeline

Phase 2CompletedFinished
20192020202120222023202420252026
First PostedAug 13, 2020
Enrollment StartJun 14, 2018
Primary CompletionJul 24, 2018
Study CompletionMar 4, 2019
TodayJul 2, 2026
Enrollment to primary: 1 monthPosted 5.9 years ago

Interventions

Bromelaindrug

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.

Powdered sugarother

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.