The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity

This single centre, dual site, comparative design study will be used to investigate the efficacy of an experimental stannous fluoride containing dentifrice in relieving dentinal hypersensitivity (DH) after short term use

Study Overview

• Status: Completed
• Conditions: Dentin Sensitivity
• Intervention / Treatment: Device: Stannous Fluoride dentifice; Other: Sodium Monofluorophosphate dentifrice

• Study Type: Interventional
• Enrollment (Actual): 488
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Wirral, United Kingdom, CH41 6EY
    • GSK Investigational Site
  • Cheshire
    • Ellesmere Port, Cheshire, United Kingdom, CH65 4BW
      • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
• Good general and mental health with, in the opinion of the investigator or medically qualified designee:

A. No clinically significant and relevant abnormalities in medical history or upon oral examination.

B. Absence of any condition that would impact on the participant's safety or wellbeing or affect the individual's ability to understand and follow study procedures and requirements.

- Dental health

At Screening:

A. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.

B. Good general oral health, with a minimum of 20 natural teeth.

C. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria:

• Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).
• Tooth with modified gingival index (MGI) score =0 adjacent to the test area (exposed dentine) only and a clinical mobility of ≤1.
• Tooth with signs of sensitivity measured by qualifying evaporative air assessment (Y/N response).

At Baseline:

D. Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria:

- Tooth with signs of sensitivity, measured by qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff Sensitivity Score ≥ 2)

Exclusion Criteria:

• Pregnant or breast feeding women
• Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.
• Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
• Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia. - 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 xerostomia.
• Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
• Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
• Recent history (within the last year) of alcohol or other substance abuse
• Dental prophylaxis within four weeks of Screening.
• Tongue or lip piercing or presence of dental implants.
• Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
• Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of Screening, scaling or root planning within 3 months of Screening.
• Teeth bleaching within eight weeks of Screening
• Tooth with evidence of current or recent caries, or reported treatment of decay within 12 months of Screening.
• Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine.
• Sensitive tooth not expected to respond to treatment with an over-the-counter toothpaste in the opinion of the investigator.
• Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening
• Individuals who require antibiotic prophylaxis for dental procedures

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Stannous Fluoride dentifice; Participants will apply (under supervision) a pea-sized dose of experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm) to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted	Device: Stannous Fluoride dentifice; Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)
Other: Sodium Monofluorophosphate dentifrice; Participants will apply (under supervision) a pea-sized dose of dentifrice containing Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)to each of the two qualifying teeth using their finger by direct application and gently rubbing into the tooth's cervical margin for the allocated time. No rinsing will be permitted.	Other: Sodium Monofluorophosphate dentifrice; Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Schiff Sensitivity Score on Day 3	The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows - 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.	Baseline to 3 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application	The examiner assessed the participant's response to an evaporative air stimulus for each tooth using the Schiff Sensitivity Scale which was scored as follows 0: Participant does not respond to air stimulation; 1: Participant responded to air stimulus but does not request discontinuation of stimulus; 2: Participant responded to air stimulus and requests discontinuation or moves from stimulus; 3: Participant responded to stimulus, considered stimulus to be painful, and requested discontinuation of the stimulus. A reduction in Schiff Sensitivity score was indicative of an improvement in sensitivity.	Baseline to 60 seconds post first treatment
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3	The examiner assessed the response to tactile sensitivity using a Yeaple probe which allowed application of a known force to the dentin surface, starting at 10g and rising in increments of 10g until the tactile threshold or maximum force was reached. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gives two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth. At baseline, the maximum force used was 20g; at all subsequent visits, it was 80g.	Baseline, 60 seconds post first treatment, Day 3

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Study record dates

Study Major Dates

• Study Start: November 1, 2015
• Primary Completion (Actual): June 3, 2016
• Study Completion (Actual): June 3, 2016

Study Registration Dates

• First Submitted: November 19, 2015
• First Submitted That Met QC Criteria: November 19, 2015
• First Posted (Estimate): November 23, 2015

Study Record Updates

• Last Update Posted (Actual): May 17, 2017
• Last Update Submitted That Met QC Criteria: April 19, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Stomatognathic Diseases; Tooth Diseases; Hypersensitivity; Dentin Sensitivity; Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides; Tin Fluorides; Fluorophosphate
• Other Study ID Numbers: 205072