An interventional study of Sodium Fluoride Dentifrice and Stannous Fluoride Toothpaste (SnF) in Oral Malodor (Halitosis), sponsored by Church & Dwight Company, Inc.. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-02-23.
Sponsored by Church & Dwight Company, Inc. · Not applicable, Interventional, and Treatment
This single-center, randomized, double-blind, two-treatment crossover clinical study evaluated the safety and efficacy of a stannous fluoride-containing dentifrice compared with a sodium fluoride control dentifrice for the control of intrinsic oral malodor. Adult subjects brushed twice daily with each product during separate treatment periods following standardized wash-out periods. Oral malodor was assessed using trained organoleptic judges applying a validated Odor Intensity (OI) scale at baseline and multiple post-treatment time points.
This four-week, randomized, double-blind crossover study enrolled generally healthy adult subjects with qualifying intrinsic oral malodor. Following screening and an acclimation wash-out period using an ADA-accepted sodium fluoride dentifrice, subjects were randomized to one of two treatment sequences: TheraBreath® Healthy Gums Toothpaste or Crest® Cavity Protection Toothpaste. Each treatment period included supervised and at-home twice-daily brushing without tongue brushing or use of non-study oral hygiene products. Oral malodor was evaluated at baseline, 12-hour overnight, and 4- and 8-hour post-brushing time points on Day 1 and Day 7 using standardized organoleptic assessments performed by three trained judges. Safety was monitored through oral examinations and subject interviews. Treatment comparisons were analyzed using ANCOVA models appropriate for crossover designs.
93 studies on the registry are indexed under Halitosis; 17 are open to participants now.
This study's enrollment of 49 is close to the median of 45 across 79 interventional studies indexed under Halitosis.
Browse Halitosis studies →Church & Dwight Company, Inc. is the lead sponsor of 33 studies on the registry; none are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Dentifrice containing sodium fluoride, serving as the control comparator.
Drug: Sodium Fluoride Dentifrice
Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control.
Drug: Stannous Fluoride Toothpaste (SnF)
Comparator toothpaste (0.243% NaF)
Test toothpaste (0.454% SnF)
Change in Odor Intensity Score (OI
Time frame: Baseline to 12-hour overnight assessment after 7 days of product use
Change in Odor Intensity Score at Day 1
Time frame: Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment.
Daytime Odor Intensity Scores
Time frame: 4 and 8 hours post-brushing on Day 1 and Day
Plan to share: No — The sponsor does not plan to share individual participant data. Summary results will be provided as required, but no de-identified datasets will be made publicly available.
No publications or documents are linked to this record.
Ran from Sep 2024 to primary completion in Nov 2024, 1 month.
Of 43 interventional studies with no phase under Halitosis, half reached primary completion within 10 months of starting (the median), counting those still running; a quarter within 3 and three quarters within 18. This study's 1 month is below that.
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This study is completed, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Tin Fluorides
Church & Dwight Company, Inc. →