Not yet recruitingInterventionalPhase 3Updated Jul 28, 2026
A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene | NCT02613130 | Trialant
CompletedInterventionalNot ApplicableUpdated Oct 3, 2017
A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene
ClinicalTrials.gov ID
NCT02613130
Lead Sponsor
Procter and GambleINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
60Actual
Last Update Posted
Oct 3, 2017Actual
Start Date
Nov 2015
Primary Completion Date
Dec 2015Actual
Completion Date
Dec 2015Actual
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.
Oral Malodor
Stannous fluoride toothpaste
Potassium nitrate toothpaste
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility Criteria
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