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

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 Overview

• Status: Completed
• Conditions: Oral Malodor
• Intervention / Treatment: Drug: Stannous fluoride toothpaste; Drug: Potassium nitrate toothpaste

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Whittier, California, United States, 90604
      • University Health Resources Group

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Two-Step stannous fluoride toothpaste	Drug: Stannous fluoride toothpaste
Active Comparator: Potassium nitrate toothpaste	Drug: Potassium nitrate toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Breath odor	Breath measured using a hedonic malodor evaluation	Baseline
Breath odor	Breath measured using a hedonic malodor evaluation	2 Weeks

Collaborators and Investigators

• Sponsor: Procter and Gamble

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): December 1, 2015
• Study Completion (Actual): December 1, 2015

Study Registration Dates

• First Submitted: November 13, 2015
• First Submitted That Met QC Criteria: November 20, 2015
• First Posted (Estimate): November 24, 2015

Study Record Updates

• Last Update Posted (Actual): October 3, 2017
• Last Update Submitted That Met QC Criteria: September 29, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides
• Other Study ID Numbers: 2015110

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No