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

NCT03965039 | Completed Results FDA Device

• 1 other identifier: 2019079
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Dentin Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Air Challenge

  The Schiff Sensitivity Scale will be assessed for each test tooth via an evaporative air challenge. The examiner will record the Schiff Index score corresponding to the response to the air challenge. The Schiff Index Sensitivity scale is scored as follows- 0: tooth/subject did not respond to stimulus, 1: tooth/subject responds to stimulus, but does not request discontinuation of stimulus, 2: tooth/subject responds to stimulus and requests discontinuation or moves form stimulus, 3: tooth/subject responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. The higher the Schiff score, the more sensitive the tooth. The least square mean will be calculated for this measure.

  4 weeks

Secondary Outcomes (11)

• Baseline Air Challenge

  Baseline

• Air Challenge

  3 days

• Air Challenge

  2 weeks

• Air Challenge

  8 weeks

• Air Challenge

  11 weeks

Study Arms (4)

Marketed stannous fluoride toothpaste

ACTIVE COMPARATOR

Brush twice daily

Drug: Stannous fluoride toothpaste

Marketed potassium nitrate toothpaste

ACTIVE COMPARATOR

Brush Twice Daily

Drug: Potassium nitrate toothpaste

Marketed sodium monofluorophosphate toothpaste

PLACEBO COMPARATOR

Brush Twice Daily

Drug: Sodium monofluorophosphate toothpaste

Experimental dipotassium oxalate toothpaste

EXPERIMENTAL

Brush Twice Daily

Device: Dipotassium oxalate toothpaste

Interventions

Dipotassium oxalate toothpaste DEVICE

Experimental dipotassium oxalate (3%) toothpaste

Experimental dipotassium oxalate toothpaste

Stannous fluoride toothpaste DRUG

Marketed stannous fluoride (0.454%) toothpaste

Marketed stannous fluoride toothpaste

Potassium nitrate toothpaste DRUG

Marketed potassium nitrate (5%) toothpaste

Marketed potassium nitrate toothpaste

Sodium monofluorophosphate toothpaste DRUG

Marketed sodium monofluorophosphate (0.76%) toothpaste

Marketed sodium monofluorophosphate toothpaste

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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;

Sponsors & Collaborators

• Procter and Gamble: lead

Study Sites (1)

Silverstone Research Group

Las Vegas, Nevada, 89146, United States

Location

Related Publications (1)

• 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.

  PMID: 40444818 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: Procter and Gamble

peters.j.2@pg.com

513-622-2489

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2019
• First Posted: May 28, 2019
• Study Start: July 8, 2019
• Primary Completion: October 3, 2019
• Study Completion: October 3, 2019
• Last Updated: October 30, 2020
• Results First Posted: October 30, 2020

Record last verified: 2020-10

Locations

US (1)