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A Clinical Study of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene

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ClinicalTrials.gov Identifier: NCT02221349
Recruitment Status : Completed
First Posted : August 20, 2014
Last Update Posted : January 12, 2015
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
This study will compare the safety and effectiveness of normal oral hygiene with two different marketed dentifrices, on longer term dentinal hypersensitivity response following use of potassium oxalate desensitizers.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Device: Potassium oxalate Drug: Sodium fluoride paste Drug: Stannous fluoride paste Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Study of the Safety and Effectiveness of Two Dentinal Hypersensitivity Treatments Used With Normal Oral Hygiene
Study Start Date : August 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride

Arm Intervention/treatment
oxalate liquid & gel plus SnF2 paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Stannous fluoride paste, self applied
Device: Potassium oxalate
Professionally applied (liquid) and self applied (gel)

Drug: Stannous fluoride paste
Toothpaste used by subject
Other Name: SnF2 paste

oxalate liquid & gel plus NaF paste
Potassium oxalate liquid, professionally applied Potassium oxalate gel, self applied Sodium fluoride paste, self applied
Device: Potassium oxalate
Professionally applied (liquid) and self applied (gel)

Drug: Sodium fluoride paste
Toothpaste used by subject
Other Name: NaF paste




Primary Outcome Measures :
  1. Dentin sensitivity [ Time Frame: 60 days ]
    Schiff Index


Secondary Outcome Measures :
  1. Dentin sensitivity [ Time Frame: 60 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:

  • 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
  • Complete a confidentiality disclosure agreement
  • Be in good general health as determined by the Investigator/designee
  • Have at least one tooth with a Schiff sensitivity score of at least 1 in response to the air challenge.

Exclusion Criteria:

  • Self-reported pregnancy or nursing
  • Severe periodontal disease, as characterized by purulent exudate, generalized mobility, and/or severe recession
  • Active treatment of periodontitis
  • Fixed facial orthodontic appliances
  • A history of kidney stones
  • Known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate
  • Any diseases or conditions that might interfere with the safe completion of the study
  • An inability to undergo any study procedures.

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): NCT02221349


Locations
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United States, California
Chad J Anderson DMD Inc
Fresno, California, United States, 93730
Sponsors and Collaborators
Procter and Gamble
Investigators
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Principal Investigator: Chad J Anderson, MS, DMD Chad J Anderson DMD Inc

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Responsible Party: Procter and Gamble
ClinicalTrials.gov Identifier: NCT02221349     History of Changes
Other Study ID Numbers: 2014069
First Posted: August 20, 2014    Key Record Dates
Last Update Posted: January 12, 2015
Last Verified: January 2015

Keywords provided by Procter and Gamble:
Sensitivity

Additional relevant MeSH terms:
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Fluorides
Sodium Fluoride
Tin Fluorides
Listerine
Hypersensitivity
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents