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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.
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Inclusion criteria
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 desensitizing treatment or having used over-the-counter desensitizing products within 6 weeks of the Baseline visit;
having periodontal surgery, orthodontic treatment, or teeth restored in the preceding three months;
having teeth or periodontium with pathology or defects likely to cause pain;
having a history of allergies or hypersensitivity to ingredients in commercial dental products or cosmetics;
self-reported pregnancy or lactation;
having self-reported eating disorders, uncontrolled gastroesophageal reflux disease (GERD or Acid Reflux), excessive dietary or environmental exposure to acids, or other systemic conditions that are predisposing to dentinal hypersensitivity;
history or presence of kidney disorders, kidney stones, have celiac disease, inflammatory bowel disease (ulcerative colitis or Crohn's disease), chronic pancreatitis, have had intestinal or weight-loss surgery, or if have stomach or intestinal problems that keep them from absorbing certain foods or nutrients;
any diseases or condition that might interfere with the safe participation in the study;
inability to undergo study procedures;
having severe xerostomia;
having had active caries within the 12 months;
having high risk for caries development (rampant caries, multiple dental restorations, crowns with compromised margin) per examiners discretion;
teeth will be excluded from study measurements if they:
Primary purpose
Allocation
Interventional model
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120 participants in 4 patient groups, including a placebo group
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Data sourced from clinicaltrials.gov
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