A Study to Evaluate Oral Malodor and Other Outcomes Following The Use of Two-Step Toothpaste Oral Hygiene

Procter & Gamble (P&G)

Status

Completed

Conditions

Oral Malodor

Treatments

Drug: Stannous fluoride toothpaste

Drug: Potassium nitrate toothpaste

Study type

Interventional

Funder types

Industry

Identifiers

NCT02613130

2015110

Details and patient eligibility

About

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.

Enrollment

60 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

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.