A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity

This is an interventional treatment trial for Dentin Hypersensitivity Read More

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 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:

  • have deep, defective, or facial restorations;
  • have full crowns, extensive caries, cracked enamel, or are abutment teeth for fixed or removable prosthesis;
  • present with tendency for spontaneous bleeding;
  • have been scaled/root planed or restored within the past 3 months.