Evaluation of a Stannous Fluoride Dentifrice for Control of Oral Malodor

Conditions

• Oral Malodor (Halitosis)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Accepted

Interventions

• Sodium Fluoride Dentifrice — DRUG
  Comparator toothpaste (0.243% NaF)
• Stannous Fluoride Toothpaste (SnF) — DRUG
  Test toothpaste (0.454% SnF)

Study Details

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.

Key Dates

Start date

Sep 9, 2024

Status verified

Feb 2026

Primary completion

Nov 4, 2024

Completion

Nov 4, 2024

Study Design

Enrollment

49 participants (actual)

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Arms

• Other: Sodium Fluoride Control Dentifrice
  Dentifrice containing sodium fluoride, serving as the control comparator.
• Experimental: Stannous Fluoride Toothpaste
  Dentifrice containing stannous fluoride evaluated for malodor reduction compared to sodium fluoride control.

Primary Outcome Measure

Change in Odor Intensity Score (OI [ Time Frame: Baseline to 12-hour overnight assessment after 7 days of product use ]

Locations (1)

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