NCT02613130CompletedNot Applicable
A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
Procter and Gamble1 site in 1 country60 target enrollmentStarted: November 2015Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 60
- Locations
- 1
- Primary Endpoint
- Breath odor
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Arms & Interventions
Two-Step stannous fluoride toothpaste
Experimental
Two-Step stannous fluoride toothpaste
Intervention: Stannous fluoride toothpaste (Drug)
Potassium nitrate toothpaste
Active Comparator
Potassium nitrate toothpaste
Intervention: Potassium nitrate toothpaste (Drug)
Outcomes
Primary Outcomes
Breath odor
Time Frame: 2 Weeks
Breath measured using a hedonic malodor evaluation
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (1)
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