Status:
COMPLETED
Evaluation of the Safety and Efficacy of an Oxalate Gel or Negative Control on Dentinal Hypersensitivity
Lead Sponsor:
Procter and Gamble
Conditions:
Dentin Sensitivity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
This study will compare the safety and effectiveness of a potassium oxalate desensitizer or negative control on dentinal hypersensitivity.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
June 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
70 Patients enrolled
Trial Details
Trial ID
NCT02189382
Start Date
June 1 2014
End Date
July 1 2014
Last Update
August 20 2018
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Silverstone Research Group
Las Vegas, Nevada, United States, 89146