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OpenTrials
Completed

NCT Number: NCT02613130

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Health Resources Group

Whittier, California, 90604, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

stannous fluoride toothpaste

Drug

Potassium nitrate toothpaste

Drug

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Procter and Gamble

Industry

Registry information

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Nov 24, 2015
Registry last updated
Oct 3, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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