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Trial record 69 of 292 for:    Sodium Fluoride OR Duraphat

A Pilot Clinical Study to Evaluate the Safety and Efficacy of Marketed Oxalate Strips Compared to a Marketed Safety Pen

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: NCT02384044
Recruitment Status : Completed
First Posted : March 10, 2015
Results First Posted : May 21, 2019
Last Update Posted : June 25, 2019
Information provided by (Responsible Party):
Procter and Gamble

Brief Summary:
This pilot study will evaluate the safety and effectiveness of a marketed sensitivity strip on existing dentinal hypersensitivity compared to a marketed sensitivity pen.

Condition or disease Intervention/treatment Phase
Dentin Sensitivity Device: Crest® Sensi-Stop™ Strips Device: Colgate® Sensitivity Relief Pen Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2015
Actual Primary Completion Date : March 2015
Actual Study Completion Date : March 2015

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy

Arm Intervention/treatment
Active Comparator: Crest® Sensi-Stop™ Strips
Professionally Applied
Device: Crest® Sensi-Stop™ Strips
Active Comparator: Colgate® Sensitivity Relief Pen
Professionally Applied
Device: Colgate® Sensitivity Relief Pen

Primary Outcome Measures :
  1. Change From Baseline Visual Analog Scale [ Time Frame: 1 Day ]
    Visual Analog Scale (VAS) - subjects are asked to look at a VAS and designate the level of hypersensitivity they experienced as a result of the thermal and water challenges using a continuum scale of 0 = No tooth pain up to 100 = Worst tooth pain ever experienced. A negative change from Baseline score represents a decrease in sensitivity from baseline.

Secondary Outcome Measures :
  1. Change From Baseline for Air Challenge [ Time Frame: 1 Day ]
    The Schiff Sensitivity Scale was assessed for each test tooth via an evaporative air challenge. The examiner recorded the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A negative change from Baseline score represents a decrease in sensitivity from baseline.The mean change from Baseline was calculated for this measure.

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, including dental prophylaxis, 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 dentinal hypersensitivity with at least one tooth with a Schiff sensitivity score of at least 1 in response to the cold water 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 facial orthodontic appliances
  • a history of kidney stones
  • self-reported pregnancy or nursing
  • known allergies to the following ingredients; aqua, glycerin, cellulose gum, dipotassium oxalate, carbomer, sodium hydroxide, sodium benzoate, and potassium sorbate

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): NCT02384044

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United States, Ohio
Oral Health Science Center
Mason, Ohio, United States, 45040
Sponsors and Collaborators
Procter and Gamble
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Principal Investigator: Robert W Gerlach, DDS, MPH Procter and Gamble

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Responsible Party: Procter and Gamble Identifier: NCT02384044     History of Changes
Other Study ID Numbers: 2015012
First Posted: March 10, 2015    Key Record Dates
Results First Posted: May 21, 2019
Last Update Posted: June 25, 2019
Last Verified: June 2019
Keywords provided by Procter and Gamble:
Additional relevant MeSH terms:
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Sodium Fluoride
Dentin Sensitivity
Immune System Diseases
Tooth Diseases
Stomatognathic Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents