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Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity

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.
 
ClinicalTrials.gov Identifier: NCT02189382
Recruitment Status : Completed
First Posted : July 14, 2014
Results First Posted : August 20, 2018
Last Update Posted : August 20, 2018
Sponsor:
Information provided by (Responsible Party):
Procter and Gamble

Tracking Information
First Submitted Date  ICMJE July 8, 2014
First Posted Date  ICMJE July 14, 2014
Results First Submitted Date  ICMJE May 9, 2018
Results First Posted Date  ICMJE August 20, 2018
Last Update Posted Date August 20, 2018
Study Start Date  ICMJE June 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Change From Baseline Air Challenge [ Time Frame: 30 days ]
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. The higher the Schiff score, the more sensitive the tooth. The mean change from Baseline was calculated for this measure.
Original Primary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Dentin Sensitivity Air [ Time Frame: 30 days ]
Schiff Index
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 20, 2018)
Change From Baseline in Tactile Threshold [ Time Frame: 30 days ]
Tactile Threshold was measured using a Yeaple probe. Testing was performed beginning at 10 g. The examiner recorded tactile scores for responding teeth. After treatment, testing began at 10 g and increase by 10 g to a maximum of 50 g. The higher the tactile threshold, the less sensitive the tooth. Each successive challenge increased until a "yes" response was repeated. If a second "yes" was not obtained, the force setting was increased to the next step and continued until a force was found which elicited two consecutive "yes" responses and was recorded as the threshold on the Tactile Sensitivity Score form. The mean change from Baseline was calculated for this measure.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 10, 2014)
Dentin Sensitivity Tactile [ Time Frame: 30 days ]
Yeaple Probe
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Official Title  ICMJE Not Provided
Brief Summary This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Condition  ICMJE Dentin Sensitivity
Intervention  ICMJE
  • Device: Potassium Oxalate
  • Other: Water
Study Arms  ICMJE
  • Experimental: Potassium Oxalate Gel
    Self Applied
    Intervention: Device: Potassium Oxalate
  • Water
    Self Applied
    Intervention: Other: Water
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2014)
70
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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;
  • agree not to participate in any other oral/dental product studies during the course of this study;
  • agree to delay any dentistry (including dental prophylaxis) until the study has been completed;
  • agree to refrain from the use of any non-study oral hygiene products;
  • agree to return for all scheduled visits and follow study procedures; and.
  • 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:

  • 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; or
  • an inability to undergo any study procedures.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02189382
Other Study ID Numbers  ICMJE 2014029
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Procter and Gamble
Study Sponsor  ICMJE Procter and Gamble
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Procter and Gamble
Verification Date July 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP