Oral Malodor
Conditions
Brief summary
To investigate the clinical efficacy of a new toothpaste containing 0.454% stannous fluoride as compared to a regular fluoride toothpaste containing 0.76% sodium monofluorophosphate on oral malodor reduction via organoleptic scores 12 hours post-brushing overnight after 3 weeks of twice a day (morning and evening) product use.
Interventions
fluoride toothpaste
regular fluoride toothpaste
Sponsors
Colgate Palmolive
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Male and female adults between the ages of 18-70 (inclusive) * Subjects must be in general good health * Subjects must be in good oral health based on self-assessment * Subjects must be available for the duration of the study for all time point assessments * Subjects were required to possess a minimum of 20 natural uncrowned teeth (excluding third molars) * Subjects were required to sign an Informed Consent form * No known history or allergies to personal care/consumer products or their ingredients.
Exclusion criteria
* Participated in any other oral clinical studies during the duration of this study * Had full or partial (upper or lower) dentures * Women who are pregnant or lactating (breast feeding) * Use of tobacco products, (5) History of allergies to common mouthwash ingredients * Use of phenolic flavored products, such as mint flavored candies and chewing gum the morning of the study of during the sampling periods * Immune compromised individuals (HIV, AIDS, immune suppressive drug therapy * Individuals who, due to medical conditions cannot go without eating or drinking for the post use treatment evaluation time points (6-hours plus overnight).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean Organoleptic scores for each treatment group | Baseline, 12 hours post brushing and 3 weeks | For each subject at each evaluation time point, the hedonic breath-odor scores assigned by the four (4) judges were averaged to yield a single subject-wise score. Statistical analyses were performed on these average organoleptic hedonic scores. |
Countries
Thailand
Outcome results
None listed