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Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Dental Hypersensitivity

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ClinicalTrials.gov Identifier: NCT02152826
Recruitment Status : Completed
First Posted : June 2, 2014
Last Update Posted : November 18, 2014
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
This study will compare the safety and effectiveness of two water-based potassium oxalate desensitizers on existing dentinal hypersensitivity.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Device: Potassium oxalate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Clinical Study Comparing the Safety and Effectiveness of Two Water-Based Potassium Oxalate Desensitizers on Existing Dentinal Hypersensitivity
Study Start Date : March 2014
Actual Primary Completion Date : September 2014
Actual Study Completion Date : September 2014

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: potassium oxalate gel
Professional application
Device: Potassium oxalate
Professional application

Active Comparator: Potassium oxalate liquid
Professional application
Device: Potassium oxalate
Professional application




Primary Outcome Measures :
  1. Dentin sensitivity [ Time Frame: up to 150 days ]
    Schiff Index


Secondary Outcome Measures :
  1. Dentin sensitivity [ Time Frame: up to 150 days ]
    Visual Analog Scale



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
Criteria

Inclusion Criteria:

  • Provide written informed consent to participate in the study
  • Be at least 18 years of age
  • Be in good general health, as determined by the Investigator/designee based on review of the health history/update for participation in the study
  • Agree to refrain from participating in any other oral/dental product studies for the duration of the study
  • Agree to refrain from receiving any elective dentistry (including dental prophylaxis) for the duration of the study
  • Agree to refrain from using any oral hygiene products other than the assigned study products for the duration of the study
  • Agree to comply with study/product usage instructions; and
  • Have at least one tooth with gingival recession and hypersensitivity evidenced by a score of ≥ 1 on the Cold Air Sensitivity Schiff scale during screening

Exclusion Criteria:

  • Gross oral neglect or urgent dental treatment needs
  • Severe periodontal disease and/or generalized mobility
  • Active treatment for periodontitis
  • Any disease or condition that could be expected to interfere with examination procedures or safe completion of the study
  • Self-reported pregnancy or nursing

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): NCT02152826


Locations
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United States, Massachusetts
Tufts University School of Dental Medicine
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Procter and Gamble
Investigators
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Principal Investigator: Athena Papas, DMD, PhD Tufts University School of Dental Medicine

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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02152826     History of Changes
Other Study ID Numbers: 2013145
First Posted: June 2, 2014    Key Record Dates
Last Update Posted: November 18, 2014
Last Verified: November 2014
Keywords provided by Procter and Gamble:
Sensitivity
Additional relevant MeSH terms:
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Dentin Sensitivity
Hypersensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases