deltatrials
Completed PHASE2 INTERVENTIONAL 2-arm NCT04512482

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

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

Sponsor: Delta Dental Foundation

Updated 4 times since 2020 Last updated: Nov 8, 2020 Started: Jun 14, 2018 Primary completion: Jul 24, 2018 Completion: Mar 4, 2019
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT04512482, this PHASE2 trial focuses on Dental Caries and Dental Plaque and remains completed. Sponsored by Delta Dental Foundation, it has been updated 4 times since 2018, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Study Description(click to expand)

Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In vitro bromelain study demonstrated antibacterial effect on oral pathogens. Bromelain was found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The impact of bromelain application prior to traditional mechanisms of plaque removal have not been clearly evaluated.

Bromelain, a naturally occurring cysteine protease, from pineapple stalks, is used in food and medical industries and listed on the FDA's "Generally Recognized As Safe" (GRAS) list. In vitro bromelain study demonstrated antibacterial effect on oral pathogens. Bromelain was found to prevent biofilm formation by interfering with bacteria-bacteria adhesion and/or adhesion to enamel surface. Clinical trials with toothpaste containing bromelain demonstrated improved plaque and gingivitis scores and extrinsic enamel stain removal capabilities. The impact of bromelain application prior to traditional mechanisms of plaque removal have not been clearly evaluated.

Status Flow

~Sep 2020 – ~Jan 2021 · 4 months · monthly snapshot~Jan 2021 – ~Jul 2024 · 42 months · monthly snapshotCompleted~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – present · 19 months · monthly snapshotCompleted

Change History

4 versions recorded
  1. Sep 2024 — Present [monthly]

    Completed PHASE2

  2. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2

  3. Jan 2021 — Jul 2024 [monthly]

    Completed PHASE2

    Phase: PHASE4PHASE2

  4. Sep 2020 — Jan 2021 [monthly]

    Completed PHASE4

    First recorded

Jun 2018

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Delta Dental Foundation
  • Indiana University
  • Water Pik, Inc.
Data source: Indiana University

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations