A Clinical Study to Assess the Effects of Various Dentifrice Technologies on Dentinal Hypersensitivity
NCT ID: NCT03965039
Last Updated: 2020-10-30
Study Results
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View full resultsBasic Information
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COMPLETED
NA
120 participants
INTERVENTIONAL
2019-07-08
2019-10-03
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Marketed stannous fluoride toothpaste
Brush twice daily
Stannous fluoride toothpaste
Marketed stannous fluoride (0.454%) toothpaste
Marketed potassium nitrate toothpaste
Brush Twice Daily
Potassium nitrate toothpaste
Marketed potassium nitrate (5%) toothpaste
Marketed sodium monofluorophosphate toothpaste
Brush Twice Daily
Sodium monofluorophosphate toothpaste
Marketed sodium monofluorophosphate (0.76%) toothpaste
Experimental dipotassium oxalate toothpaste
Brush Twice Daily
Dipotassium oxalate toothpaste
Experimental dipotassium oxalate (3%) toothpaste
Interventions
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Dipotassium oxalate toothpaste
Experimental dipotassium oxalate (3%) toothpaste
Stannous fluoride toothpaste
Marketed stannous fluoride (0.454%) toothpaste
Potassium nitrate toothpaste
Marketed potassium nitrate (5%) toothpaste
Sodium monofluorophosphate toothpaste
Marketed sodium monofluorophosphate (0.76%) toothpaste
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
Yes
Sponsors
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Procter and Gamble
INDUSTRY
Responsible Party
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Locations
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Silverstone Research Group
Las Vegas, Nevada, United States
Countries
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References
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Biesbrock AR, He T, Zou Y, Grender JM, Amini P, Sagel PA, Groth A, Klukowska M. Randomized clinical trial evaluating kinetic benefits of desensitizing agents: Magnitude, onset, and stability of relief. J Periodontol. 2025 May 30. doi: 10.1002/JPER.24-0688. Online ahead of print.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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2019079
Identifier Type: -
Identifier Source: org_study_id