CompletedInterventionalNot ApplicableUpdated Jun 25, 2019
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity | NCT02189382 | Trialant
CompletedInterventionalNot ApplicableUpdated Aug 20, 2018
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
ClinicalTrials.gov ID
NCT02189382
Lead Sponsor
Procter and GambleINDUSTRY
Overall Status
Completed
Study Type
Interventional
Phase
Not Applicable
Enrollment
70Actual
Last Update Posted
Aug 20, 2018Actual
Start Date
Jun 2014
Primary Completion Date
Jul 2014Actual
Completion Date
Jul 2014Actual
Brief Summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
Dentin Sensitivity
Potassium Oxalate
Water
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
Eligibility 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;
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