Trial · NCT06602466

A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health

NCT06602466, Not applicable, Completed, HALEON; results first posted 2026-01-22

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health. Trials, record NCT06602466. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT06602466

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: A Clinical Study Investigating the Effect of an Experimental Toothpaste Containing Stannous Fluoride in Improving Gingival Health
NCT number: NCT06602466
Status: Completed
Phases: Not applicable
Enrollment: 175 participants, actual
Lead sponsor: HALEON
Conditions: Dental Plaque, Gingivitis
Interventions: Test toothpaste, Colgate Cavity Protection Toothpaste
First posted: 2024-09-19
Last updated: 2026-01-22
Results first posted: 2026-01-22

Source ClinicalTrials.gov

Registered outcomes5

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Adjusted Mean Bleeding Index (BI) at Week 4	Week 4	The BI is an invasive assessment of gingival bleeding performed using a round-end probe. Presence/absence of gingival bleeding was assessed for 30 seconds after probing. BI was assessed on 3-points scale ranging from 0 to 2, where 0= Absence of bleeding on probing, 1= Bleeding observed within 30 seconds of probing, 2= Bleeding observed immediately on probing. Mean BI was calculated by taking the average over all tooth sites assessed for a participant. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Secondary	Adjusted Mean Number of Bleeding Sites (NBS) at Week 4	Week 4	The bleeding assessment was done using round-end probe. The number of bleeding sites for each participant= the number of evaluable tooth sites with bleeding observed immediately on probing or within 30 seconds of probing. Adjusted mean value was derived using ANCOVA model.
Secondary	Adjusted Mean Modified Gingival Index (MGI) at Week 4	Week 4	The MGI is a non-invasive visual assessment of gingival inflammation. MGI was assessed for all evaluable surfaces, four sites per tooth and was scored on a 5-point scale ranging from 0 to 4, where 0= Absence of inflammation, 4= Severe inflammation. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Secondary	Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4	Week 4	The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.
Secondary	Adjusted Mean Interproximal TPI at Week 4	Week 4	The TPI is a non-invasive assessment of supra-gingival plaque accumulation. The plaque was disclosed using a plaque disclosing dye solution and the TPI was assessed using a 6-point scale ranging from 0 to 5, where 0= No plaque, 5= Plaque covering 2/3 or more of the crown of the tooth. Lower score indicated improvement in the symptoms. Adjusted mean value was derived using ANCOVA model.

Source ClinicalTrials.gov

Outcomes5

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Adjusted Mean Bleeding Index (BI) at Week 4	Week 4	Modified Intent-To-Treat (mITT) Population comprised of all randomized participants who received at least one dose of investigational product and completed at least one-post Baseline BI assessment.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Number of Bleeding Sites (NBS) at Week 4	Week 4	mITT Population.	bleeding sites	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Modified Gingival Index (MGI) at Week 4	Week 4	mITT Population.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4	Week 4	mITT Population.	score on a scale	LEAST_SQUARES_MEAN
SECONDARY	Adjusted Mean Interproximal TPI at Week 4	Week 4	mITT Population.	score on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group10

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Adjusted Mean Bleeding Index (BI) at Week 4	Test Toothpaste	0.19	Standard Error 0.013	score on a scale
Adjusted Mean Bleeding Index (BI) at Week 4	Reference Toothpaste (Negative Control)	0.21	Standard Error 0.013	score on a scale
Adjusted Mean Number of Bleeding Sites (NBS) at Week 4	Test Toothpaste	30.0	Standard Error 1.96	bleeding sites
Adjusted Mean Number of Bleeding Sites (NBS) at Week 4	Reference Toothpaste (Negative Control)	32.5	Standard Error 1.93	bleeding sites
Adjusted Mean Modified Gingival Index (MGI) at Week 4	Test Toothpaste	1.79	Standard Error 0.011	score on a scale
Adjusted Mean Modified Gingival Index (MGI) at Week 4	Reference Toothpaste (Negative Control)	1.83	Standard Error 0.010	score on a scale
Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4	Test Toothpaste	2.64	Standard Error 0.037	score on a scale
Adjusted Mean Overall Turesky Plaque Index (TPI) at Week 4	Reference Toothpaste (Negative Control)	2.62	Standard Error 0.036	score on a scale
Adjusted Mean Interproximal TPI at Week 4	Test Toothpaste	3.03	Standard Error 0.039	score on a scale
Adjusted Mean Interproximal TPI at Week 4	Reference Toothpaste (Negative Control)	3.03	Standard Error 0.038	score on a scale

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Test Toothpaste	80
Overall Study	STARTED	Reference Toothpaste (Negative Control)	81
Overall Study	COMPLETED	Test Toothpaste	76
Overall Study	COMPLETED	Reference Toothpaste (Negative Control)	78
Overall Study	NOT COMPLETED	Test Toothpaste	4
Overall Study	NOT COMPLETED	Reference Toothpaste (Negative Control)	3

Source ClinicalTrials.gov

Adverse events26

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	ORAL MUCOSAL EXFOLIATION	Gastrointestinal disorders	Test Toothpaste	4	78
other	ORAL MUCOSAL EXFOLIATION	Gastrointestinal disorders	Reference Toothpaste (Negative Control)	2	83
other	HYPERAESTHESIA TEETH	Gastrointestinal disorders	Test Toothpaste	2	78
other	HYPERAESTHESIA TEETH	Gastrointestinal disorders	Reference Toothpaste (Negative Control)	1	83
other	ORAL DISCOMFORT	Gastrointestinal disorders	Test Toothpaste	2	78
other	ORAL DISCOMFORT	Gastrointestinal disorders	Reference Toothpaste (Negative Control)	0	83
other	TONGUE ULCERATION	Gastrointestinal disorders	Test Toothpaste	1	78
other	TONGUE ULCERATION	Gastrointestinal disorders	Reference Toothpaste (Negative Control)	1	83
other	GINGIVAL PAIN	Gastrointestinal disorders	Test Toothpaste	1	78
other	GINGIVAL PAIN	Gastrointestinal disorders	Reference Toothpaste (Negative Control)	0	83

1 to 10 of 26Source ClinicalTrials.gov

See all 26 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Test Toothpaste	0	78
Total, all-cause mortality	Reference Toothpaste (Negative Control)	0	83
Total, other adverse events	Test Toothpaste	13	78
Total, other adverse events	Reference Toothpaste (Negative Control)	6	83
Total, serious adverse events	Test Toothpaste	0	78
Total, serious adverse events	Reference Toothpaste (Negative Control)	0	83

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons2

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Test Toothpaste vs Reference Toothpaste (Negative Control): deaths from any cause	Trial comparisons
Test Toothpaste vs Reference Toothpaste (Negative Control): serious adverse events	Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT06602466

GET https://conductscience.org/api/trials/v1/NCT06602466/events?page=2

API reference For AI assistants