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

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Stannous Fluoride dentifice
Sodium Monofluorophosphate dentifrice
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dentin Sensitivity

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Stannous Fluoride dentifice

Sodium Monofluorophosphate dentifrice

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 19, 2015
Last Updated
April 19, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02612064
Brief Title
The Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Official Title
A Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
November 1, 2015 (undefined)
Primary Completion Date
June 3, 2016 (Actual)
Study Completion Date
June 3, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dentin Sensitivity

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
488 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stannous Fluoride dentifice
Arm Type
Experimental
Arm Description
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
Arm Title
Sodium Monofluorophosphate dentifrice
Arm Type
Other
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Stannous Fluoride dentifice
Intervention Description
Experimental dentifrice containing 0.454% w/w stannous fluoride (1100ppm)
Intervention Type
Other
Intervention Name(s)
Sodium Monofluorophosphate dentifrice
Intervention Description
Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)
Primary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score on Day 3
Description
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.
Time Frame
Baseline to 3 days
Secondary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score Post First Treatment by Direct Application
Description
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.
Time Frame
Baseline to 60 seconds post first treatment
Title
Change From Baseline in Tactile Threshold Post First Treatment by Direct Application and on Day 3
Description
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.
Time Frame
Baseline, 60 seconds post first treatment, Day 3

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Ellesmere Port
State/Province
Cheshire
ZIP/Postal Code
CH65 4BW
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Wirral
ZIP/Postal Code
CH41 6EY
Country
United Kingdom

12. IPD Sharing Statement

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

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