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Effects of an Oxalate Containing Product on Dentinal Hypersensitivity With Dental Prophylaxis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02481557
First Posted: June 25, 2015
Last Update Posted: June 30, 2015
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.
Information provided by (Responsible Party):
Procter and Gamble
  Purpose
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.

Condition Intervention
Dentin Sensitivity Device: Oxalate Salt Solution

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Procter and Gamble:

Primary Outcome Measures:
  • Dentin Sensitivity Tactile assessed by Yeaple Probe [ Time Frame: 10 Minutes ]

Secondary Outcome Measures:
  • Dentin Sensitivity Air assessed by Schiff Index [ Time Frame: 10 Minutes ]

Enrollment: 36
Study Start Date: June 2015
Study Completion Date: June 2015
Primary Completion Date: June 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxalate Salt Solution
Professionally applied
Device: Oxalate Salt Solution
Applied by dentist
No Intervention: No Treatment
No Treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • be at least 18 years of age
  • sign an informed consent form and be given a copy
  • be in good general health as determined by the Investigator/designee
  • agree to delay any elective dentistry, and to report any dentistry received during the course of the study
  • agree to not participate in any other oral care study for the duration of this study
  • agree to return for scheduled visits and follow all study procedures
  • have at least one tooth with a Schiff sensitivity score of at least 1 in response to air challenge and a Yeaple Probe score of 10-40 in response to tactile challenge.

Exclusion Criteria:

  • severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
  • active treatment for periodontitis
  • any diseases or conditions that might interfere with the subject safely completing the study
  • inability to undergo study procedures
  • fixed orthodontic appliances
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT02481557


Locations
United States, Nevada
Silverstone Research Group
Las Vegas, Nevada, United States, 89146
Sponsors and Collaborators
Procter and Gamble
  More Information

Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02481557     History of Changes
Other Study ID Numbers: 2015069
First Submitted: June 23, 2015
First Posted: June 25, 2015
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases