Clinical trial NCT03965039: A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
Official title: A Randomized Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Dentin Hypersensitivity
Lead sponsor: Procter and Gamble
Sponsor class: INDUSTRY
First posted: 2019-05-28
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


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;
* 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.

Primary outcomes:
measure: Air Challenge
timeFrame: 4 weeks
Secondary outcomes:
measure: Baseline Air Challenge
timeFrame: Baseline
measure: Air Challenge
timeFrame: 3 days
measure: Air Challenge
timeFrame: 2 weeks
measure: Air Challenge
timeFrame: 8 weeks
measure: Air Challenge
timeFrame: 11 weeks
measure: Baseline Yeaple Probe
timeFrame: Baseline
measure: Tactile Threshold
timeFrame: 3 days
measure: Tactile Threshold
timeFrame: 2 weeks
measure: Tactile Threshold
timeFrame: 4 weeks
measure: Tactile Threshold
timeFrame: 8 weeks
measure: Tactile Threshold
timeFrame: 11 weeks
Other outcomes:
Locations:
city: Las Vegas
country: United States
facility: Silverstone Research Group
state: Nevada
Study officials:
References: