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

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: NCT02481557
Recruitment Status : Completed
First Posted : June 25, 2015
Last Update Posted : June 30, 2015
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
This study will assess sensitivity during a dental prophylaxis with or without the use of a potassium oxalate salt solution.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Device: Oxalate Salt Solution Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : June 2015
Actual Primary Completion Date : June 2015
Actual Study Completion Date : June 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy Sodium

Arm Intervention/treatment
Experimental: Oxalate Salt Solution
Professionally applied
Device: Oxalate Salt Solution
Applied by dentist

No Intervention: No Treatment
No Treatment

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

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

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
  • 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

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): NCT02481557

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

Responsible Party: Procter and Gamble Identifier: NCT02481557     History of Changes
Other Study ID Numbers: 2015069
First Posted: June 25, 2015    Key Record Dates
Last Update Posted: June 30, 2015
Last Verified: June 2015

Additional relevant MeSH terms:
Dentin Sensitivity
Tooth Diseases
Stomatognathic Diseases