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NCT04033575 · ClinicalTrials.gov registry record · Phase 4

Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste

A Phase 4 study of Gingivitis, sponsored by Colgate Palmolive.

Completed
Registry status
Phase 4
Development phase
88
Enrollment target
1
Study location

NCT04033575: Completed Phase 4 study of Gingivitis, sponsored by Colgate Palmolive.

NCT04033575 is a Phase 4 study of Gingivitis that has completed, run by Colgate Palmolive. The registered enrollment target is 88 participants, below the 233-participant average among 25 other Gingivitis trials with a reported enrollment target (62% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT04033575, a Phase 4 study of Gingivitis, has completed, sponsored by Colgate Palmolive.

COMPLETED
Registry status
Phase 4
Development phase
88 participants
Enrollment target
1
Study location

Study Summary

The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.

Primary Outcome

Gingivitis scale (Loe \& Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)

Conditions Studied

Interventions

  • DRUG Colgate Total SF
  • DRUG Colgate Cavity Protection toothpaste

Study Locations (1)

Florida

  • Consumer Research Consulting, LLC - Melbourne

Trial Details

FieldValue
Enrollment Target 88 participants
Start Date 2019-03-06
Est. Completion 2019-07-01
Phase Phase 4
Colgate Palmolive

51 total trials

What the finished NCT04033575 record still lists

NCT04033575 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 88 participants, a relatively small participant target, below the 233-participant average among 25 other Gingivitis trials with a reported enrollment target (62% lower).

The record links to 1 condition, with Gingivitis appearing as the primary indexed condition, and to 2 interventions - of which Colgate Total SF is the first listed.

NCT04033575 reports a single indexed study location in Florida.

Frequently Asked Questions

What is clinical trial NCT04033575 about?

NCT04033575 is a clinical study titled "Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste". The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.

What is the current status of trial NCT04033575?

This trial is currently completed. It is a Phase 4 study. The enrollment target is 88 participants. The study started on 2019-03-06. Estimated completion is 2019-07-01.

What conditions does trial NCT04033575 study?

This clinical trial studies the following conditions: Gingivitis.

What interventions are being tested in trial NCT04033575?

The interventions under investigation include: Colgate Total SF (DRUG), Colgate Cavity Protection toothpaste (DRUG).

Who is sponsoring clinical trial NCT04033575?

This trial is sponsored by Colgate Palmolive, which has 51 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT04033575 being conducted?

This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for Gingivitis

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04033575's enrollment target sits among peer trials

88 15th of 25 higher than 11 of 25 other Gingivitis trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Gingivitis 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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Source: ClinicalTrials.gov NCT04033575, the US trial registry maintained by the National Library of Medicine. NCT04033575 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.