NCT05916508 is a NA clinical trial of 0.454% stannous fluoride in Gingivitis, sponsored by Procter and Gamble.

Who is sponsoring NCT05916508?

NCT05916508 is sponsored by Procter and Gamble.

What drugs are being tested in NCT05916508?

Interventions in NCT05916508: 0.454% stannous fluoride, 0.76% sodium monofluorophosphate, 0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM.

What condition does NCT05916508 study?

NCT05916508 studies Gingivitis.

Is NCT05916508 still recruiting?

NCT05916508 is currently completed. Last updated 23 June 2023.

Last reviewed 2023-06-23 · How we verify

NCT05916508

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

A Bleeding-Model Clinical Study

Completed NA Last updated 23 June 2023

What this trial tests

NA trial testing 0.454% stannous fluoride in Gingivitis in 90 participants. Completed in 20 November 2020.

Timeline

19 October 2020

Primary endpoint
20 November 2020

20 November 2020

Quick facts

Lead sponsor	Procter and Gamble
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	90
Start date	19 October 2020
Primary completion	20 November 2020
Estimated completion	20 November 2020
Sites	1 location across United States

Drugs / interventions tested

0.454% stannous fluoride — full drug profile →
0.76% sodium monofluorophosphate — full drug profile →
0.454% stannous fluoride AM and 0.76% sodium monofluorophosphate PM — full drug profile →

Conditions studied

Gingivitis — all drugs for Gingivitis →

Sponsor

Procter and Gamble — full company profile →

Who can join

18 and older, any sex, with Gingivitis. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Randomized Controlled Trials Assessing Exposure Frequency Effects of Stannous Fluoride on Gingivitis.
He T, Zou Y, Grender J, Amini P, et al · · 2025 · PMID 39118360 · DOI 10.1177/23800844241263031

Verify or expand the search:

Other trials of 0.454% stannous fluoride

Trials testing the same drug.

NCT05916521 — A Three Month Bleeding-Model Clinical Study · NA · completed
NCT07223073 — A Clinical Study Conducted in the Bangkok, Thailand Area, to Investigate the Clinical Efficacy of a New Toothpaste · Phase 3 · completed
NCT07223060 — Efficacy of Toothpaste Containing 0.454% Stannous Fluoride as Compared to a Regular Fluoride Toothpaste Containing 0.76% · Phase 2, PHASE3 · completed

Other recruiting trials for Gingivitis

Currently open trials in the same condition.

NCT07501455 — Comparison of the Effects of Oral Hygiene Regimens on Clinical, Immunomodulatory, and Microbial Outcomes and Oral Tolera · NA · recruiting
NCT07499596 — Effect of Morus Nigra Mouthwash on Gingivitis Treatment · NA · recruiting
NCT07270705 — Assessment of the Efficacy and Safety of OROXID® Oral Solution in Patients With Gingivitis · NA · recruiting
NCT07164989 — Motivational Interviewing to Improve Oral Hygiene in Adolescent Orthodontic Patients · NA · active not recruiting
NCT07530978 — ORAL HYGIENE, PERIODONTAL STATUS AND QUALITY OF LIFE · recruiting

Other Procter and Gamble trials

Trials by the same sponsor.

NCT07158112 — Assessing Gingivitis and Plaque From a Marketed Toothpaste · Phase 4 · active not recruiting
NCT06962956 — Evaluating Gingivitis and Systemic Biomarkers · Phase 1 · active not recruiting
NCT06892834 — Assessing Gingivitis of 3 Different Dentifrices Compared to a Negative Control. · Phase 2 · completed
NCT06140784 — A Clinical Study to Assess the Gingivitis and Plaque Effects of Various Dentifrices · NA · completed
NCT06140758 — Evaluation of the Anticaries Efficacy of Dentifrice Formulations Using an In-situ Model · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT05916508 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Procter and Gamble
Last refreshed: 23 June 2023

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05916508.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing