Oral Malodor (Halitosis)
Conditions
Brief summary
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.
Detailed description
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.
Interventions
Comparator toothpaste (0.243% NaF)
Test toothpaste (0.454% SnF)
Sponsors
Church & Dwight Company, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Adults ≥18 years of age in good general health * Baseline odor intensity score ≥2 after approximately 12 hours of oral hygiene abstention * Intra-oral source of oral malodor * At least 18 natural teeth * Willing to comply with oral hygiene, dietary, and behavioral restrictions * Able to provide informed consent
Exclusion criteria
* Allergy to oral hygiene products * Pregnant or nursing * Serious medical conditions affecting oral malodor * Recent antibiotic or anti-inflammatory medication use * Smoker or user of smokeless tobacco * Advanced periodontal disease, frank caries, or significant oral pathology * Participation in another oral care study within 30 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in Odor Intensity Score (OI | Baseline to 12-hour overnight assessment after 7 days of product use |
Secondary
| Measure | Time frame |
|---|---|
| Change in Odor Intensity Score at Day 1 | Mean change in Odor Intensity Scores from baseline to Day 1 overnight assessment. |
Countries
United States
Contacts
STUDY_DIRECTORAnnahita Ghassemi, PhD
Church & Dwight, Inc.
Outcome results
None listed