Phase 2 N=45 Randomized Triple-blind Supportive Care

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

Dental Plaque · Dental Caries

Bottom Line

View on ClinicalTrials.gov: NCT04512482 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2020

Primary outcome: Primary: Composite Plaque Score — 36.2; 37.9 score on a scale — p=.044

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: Bromelain (Drug); Powdered sugar (Other)
Age: Pediatric, Adult · 10+ yrs
Sex: All
Sponsor: Indiana University
Primary completion: Jul 2018

Outcome Measures

Outcome	Result	p-value
PRIMARY Composite Plaque Score	36.2; 37.9	.044 sig

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT04512482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.