A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensit… (NCT03965039) | Clinical Trial Compass
CompletedNot Applicable
A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
United States120 participantsStarted 2019-07-08
Plain-language summary
The objective of this study is to evaluate the efficacy (changes in dentinal hypersensitivity) and safety (oral soft tissue evaluation) after use of one of four dentifrices in subjects with pre-existing hypersensitivity over an 11-week period.
Who can participate
Age range18 Years
SexALL
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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;
* sign a Confidentiality Disclosure Agreement (CDA);
* 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\*;
* exhibit adequate oral hygiene (i.e., brush teeth daily and exhibit no signs of oral neglect);
* have an absence of extensive calculus above the gum line;
* agree to return for all scheduled visits and follow study procedures; and
* have two teeth with a Schiff sensitivity score \> 1 in response to air challenge and a Yeaple probe score of 10-20 g in response to tactile challenge. (If these two eligible teeth are located in the same quadrant, they have to be separated by 2 other teeth.)
Exclusion Criteria:
* having taken anti-inflammatory, analgesic, or psychotropic drugs, chronically;
* chronic medical debilitating disease associated with constant or intermittent episodes of daily pain;
* any home-care bleaching, whitening products or have had a professional bleaching treatment within 4 weeks of the Baseline visit;
* dental prophylaxis within 2 weeks prior to Baseline visit;
* having received professional desensitizin…