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Trial record 9 of 32 for:    FLUORIDE ION AND NITRATE ION

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02613130
Recruitment Status : Completed
First Posted : November 24, 2015
Last Update Posted : October 3, 2017
Information provided by (Responsible Party):
Procter and Gamble

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.

Condition or disease Intervention/treatment Phase
Oral Malodor Drug: Stannous fluoride toothpaste Drug: Potassium nitrate toothpaste Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Study Start Date : November 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : December 2015

Resource links provided by the National Library of Medicine

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

Primary Outcome Measures :
  1. Breath odor [ Time Frame: Baseline ]
    Breath measured using a hedonic malodor evaluation

  2. Breath odor [ Time Frame: 2 Weeks ]
    Breath measured using a hedonic malodor evaluation

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02613130

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United States, California
University Health Resources Group
Whittier, California, United States, 90604
Sponsors and Collaborators
Procter and Gamble

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Responsible Party: Procter and Gamble Identifier: NCT02613130     History of Changes
Other Study ID Numbers: 2015110
First Posted: November 24, 2015    Key Record Dates
Last Update Posted: October 3, 2017
Last Verified: September 2017

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs