Phase 2
Completed N=45
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
Source: ClinicalTrials.gov NCT04512482 ↗Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcomePrimary: Composite Plaque Score — 36.2; 37.9 score on a scale — p=.044
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Composite Plaque Score |
36.2; 37.9 | .044 sig |
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
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. Informational only — not medical advice.