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NCT04512482 · ClinicalTrials.gov registry record · Phase 2
Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse
A Phase 2 study, sponsored by Indiana University.
- Completed
- Registry status
- Phase 2
- Development phase
- 46
- Enrollment target
NCT04512482: Completed Phase 2 study, sponsored by Indiana University.
NCT04512482 is a Phase 2 study that has completed, run by Indiana University. The registered enrollment target is 46 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04512482, a Phase 2 study, has completed, sponsored by Indiana University.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 46 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DRUG Bromelain
- OTHER Powdered sugar
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 46 participants |
| Start Date | 2018-06-14 |
| Est. Completion | 2019-03-04 |
| Phase | Phase 2 |
What the finished NCT04512482 record still lists
NCT04512482 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 46 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (65% lower).
The record links to 0 conditions, and to 2 interventions - of which Bromelain is the first listed.
NCT04512482 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04512482 about?
NCT04512482 is a clinical study titled "Evaluation of Oral Plaque Removal Utilizing an Adjunct Enzyme Pre-rinse". 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 ri...
What is the current status of trial NCT04512482?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 46 participants. The study started on 2018-06-14. Estimated completion is 2019-03-04.
What interventions are being tested in trial NCT04512482?
The interventions under investigation include: Bromelain (DRUG), Powdered sugar (OTHER).
Who is sponsoring clinical trial NCT04512482?
This trial is sponsored by Indiana University, which has 890 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04512482's enrollment target sits among peer trials
46 1286th of 2000 higher than 705 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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