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CompletedNCT02613130Updated Oct 3, 2017

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

An interventional study of Stannous fluoride toothpaste and Potassium nitrate toothpaste in Oral Malodor, sponsored by Procter and Gamble. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-10-03.

Sponsored by Procter and Gamble · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Oral Malodor
03

In context

Lead sponsor

Procter and Gamble is the lead sponsor of 80 studies on the registry; none are open to participants now.

Of its 10 completed or terminated interventional studies of FDA-regulated products, 10 (100%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
60 participants (actual)

Study arms

  • 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

Interventions

  • DrugStannous fluoride toothpaste
  • DrugPotassium nitrate toothpaste
06

What researchers measure

Primary outcomes

  1. Breath odor

    Breath measured using a hedonic malodor evaluation

    Time frame: Baseline

  2. Breath odor

    Breath measured using a hedonic malodor evaluation

    Time frame: 2 Weeks

07

Study locations

1 site
  • University Health Resources Group
    Whittier, California 90604, United States
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT02613130
Lead sponsor
Procter and Gamble
Responsible party
Sponsor
First posted
Nov 24, 2015
Start date
Nov 2015
Primary completion
Dec 2015
Completion
Dec 2015
Last update
Oct 3, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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