Oral Malodor
Conditions
Brief summary
This study will assess changes in oral malodor and other factors in response to using a two-step toothpaste oral hygiene relative to a sensitivity whitening toothpaste.
Interventions
Sponsors
Procter and Gamble
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Be at least 18 years of age; * Provide written informed consent prior to participation and be given a signed copy of the informed consent form; * Be in general good health as determined by the Investigator based on a review of the health history/update for participation in the trial; * Have an average hedonic score of at least 6.5; * Have at least 16 gradable teeth; * Have at least 10 bleeding sites; * Have a Lobene composite stain score of ≥1 on at least 1 tooth; * Have at least one test tooth with recession and a score of 6 or greater on the nine-point comfort/discomfort sensitivity scale; * Agree to return for scheduled visits and follow the study procedures; * Agree to refrain from use of any non-study oral hygiene products for the duration of the study; * Agree to refrain from tongue brushing for the duration of the study; * Agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study; * Agree to abstain from eating, drinking, chewing gum, using tobacco products, and any oral hygiene at least eight hours prior to evaluation of oral malodor; and * Agree to refrain from using deodorant, body lotion/powder/spray, hair products, perfume/cologne, lipstick/gloss, or any other scented products on the mornings of the evaluation days prior to their visit to the clinic.
Exclusion criteria
* Oral malodor of systemic origin as determined by health history or examination; * Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession; * Active treatment for periodontitis; * Removable oral appliances; * Fixed facial or lingual orthodontic appliances; * Antibiotic use within four weeks of the Screening visit; * Any disease or condition that might interfere with the safe participation in the study; and * Inability to undergo study procedures.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Breath odor | Baseline | Breath measured using a hedonic malodor evaluation |
Countries
United States
Outcome results
None listed