Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity

NCT01827670 | Completed Phase 3 Results

• 1 other identifier: RH01685
• Study Type: interventional
• Target: 119
• Locations: 1 country
• Sites: 1

Brief Summary

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

• Mean Change From Baseline in Schiff Sensitivity Score

  The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation

  Baseline-Week 8

Secondary Outcomes (5)

• Mean Change From Baseline in Schiff Sensitivity Score

  Baseline-Week 4

• Mean Change From Baseline in Tactile Sensitivity

  Baseline-Week 8

• Mean Change From Baseline in Tactile Sensitivity

  Baseline-Week 4

• Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)

  Baseline-Week 4

• Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)

  Baseline - Week 8

Study Arms (2)

0.454% stannous fluoride dentifrice

EXPERIMENTAL

Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water.

Drug: Stannous fluoride

0.76% sodium monofluorophosphate dentifrice

ACTIVE COMPARATOR

Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.

Drug: Sodium monofluorophosphate

Interventions

Stannous fluoride DRUG

Test dentifrice containing 0.454% SnF

0.454% stannous fluoride dentifrice

Sodium monofluorophosphate DRUG

Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate \[1000 parts per million (ppm) fluoride\]

0.76% sodium monofluorophosphate dentifrice

Eligibility Criteria

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

You may qualify if:

• Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
• Participants with minimum of 20 natural teeth.
• At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
• Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
• Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
• Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

You may not qualify if:

• Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
• Any condition which, in the opinion of the investigator, causes dry mouth.
• Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
• Participant using of a desensitising dentifrice within 6 weeks of screening

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

Salus Research, Inc.

Fort Wayne, Indiana, 46825, United States

Location

Related Publications (1)

• Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6.

  PMID: 26437498 DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tin Fluorides; fluorophosphate

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Fluorides; Hydrofluoric Acid; Fluorine Compounds; Inorganic Chemicals; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 5, 2013
• First Posted: April 9, 2013
• Study Start: February 1, 2013
• Primary Completion: May 1, 2013
• Study Completion: May 1, 2013
• Last Updated: January 26, 2015
• Results First Posted: January 26, 2015

Record last verified: 2015-01

Locations

US (1)