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Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

Primary Purpose

Dentin Sensitivity

Status
Completed
Phase
Phase 4
Locations
Canada
Study Type
Interventional
Intervention
Stannous Fluoride Dentifrice
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 - 65 Years (Adult, Older 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.
  • Aged 18-65 years inclusive.
  • Good general and mental health with:

No clinically significant and relevant abnormalities of medical history or oral examination.

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.

  • Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years.
  • Minimum of 20 natural teeth.
  • Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR).

Tooth with 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 (yes[Y]/No[N] response).

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

Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2).

Exclusion Criteria:

  • Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study.
  • Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
  • Previous participation in this study or 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.
  • Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia.
  • Dental prophylaxis within 4 weeks of Screening.
  • Tongue or lip piercing or presence of dental implants.
  • 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 8 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 dentifrice.
  • Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening.
  • Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain.

Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.

  • Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline.
  • Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia.

Sites / Locations

  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

Stannous Fluoride Dentifrice

Sodium monofluorophosphate Dentifrice

Arm Description

Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.

Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.

Outcomes

Primary Outcome Measures

Change From Baseline in Schiff Sensitivity Score at Day 14
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.

Secondary Outcome Measures

Change From Baseline in Schiff Sensitivity Score at Day 7
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Change From Baseline in Tactile Threshold at Day 7 and Day 14
A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.

Full Information

First Posted
May 12, 2016
Last Updated
August 31, 2017
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT02773758
Brief Title
Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity
Official Title
Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
Study Type
Interventional

2. Study Status

Record Verification Date
August 2017
Overall Recruitment Status
Completed
Study Start Date
January 1, 2016 (Actual)
Primary Completion Date
March 11, 2016 (Actual)
Study Completion Date
March 11, 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 will be a single centre, two week, randomised, examiner blind, two treatment arm, parallel design, stratified (by maximum baseline Schiff sensitivity score of the two selected test teeth), controlled study, in participant with at least two sensitive teeth that meet the study criteria at the Screening and Baseline visits. The study will be conducted in participants in good general health, with pre-existing self-reported and clinically diagnosed tooth sensitivity at screening.

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
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
143 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Stannous Fluoride Dentifrice
Arm Type
Experimental
Arm Description
Participants will be instructed to topically dose a dry toothbrush with a full strip of toothpaste, then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute twice daily (morning and evening). Participants will be permitted to rinse with tap water.
Arm Title
Sodium monofluorophosphate Dentifrice
Arm Type
Other
Arm Description
Participants will be instructed to topically apply a full brush head of toothpaste to a dry toothbrush, then brush the whole mouth thoroughly for at least 1 minute. Participants will be permitted to rinse with tap water.
Intervention Type
Other
Intervention Name(s)
Stannous Fluoride Dentifrice
Intervention Description
Experimental dentifrice containing 0.454%w/w stannous fluoride (1100ppm fluoride)
Intervention Type
Other
Intervention Name(s)
Sodium monofluorophosphate Dentifrice
Intervention Description
Dentifrice containing 0.76% w/w sodium monofluorophosphate (1000ppm fluoride)
Primary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score at Day 14
Description
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
Baseline, Day 14
Secondary Outcome Measure Information:
Title
Change From Baseline in Schiff Sensitivity Score at Day 7
Description
Schiff Sensitivity Score is an examiner based index, was scored immediately following administration of the evaporative air stimulus by directing a maximum one second application of air from a dental air syringe to the exposed dentine surface from a distance of approximately 1 cm. The examiner indicated the participant's response to the evaporative air stimulus, after the stimulation of each individual tooth, using the Schiff sensitivity scale as follows: 0= participant does not respond to air stimulation; 1= participant responds to air stimulus but does not request discontinuation of stimulus; 2= participant responds to air stimulus and requests discontinuation or moves from stimulus; 3= participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus.
Time Frame
Baseline, Day 7
Title
Change From Baseline in Tactile Threshold at Day 7 and Day 14
Description
A tactile stimulus was administered using a constant pressure probe (Yeaple Probe). Response to this stimulus was evaluated as tactile threshold. The constant pressure probe allowed the examiner to vary the force applied to the dentine surface from 10 g to an upper threshold of 80 g in increments of 10 g. The tactile threshold is the maximum pressure applied without the participant's reporting pain or discomfort. The greater the tactile threshold, the less sensitive the tooth.
Time Frame
Baseline, Day 7 and Day 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 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. Aged 18-65 years inclusive. Good general and mental health with: No clinically significant and relevant abnormalities of medical history or oral examination. 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. Self-reported history of dentinal hypersensitivity (DH) lasting more than six months but not more than 10 years. Minimum of 20 natural teeth. Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants, that meet all of the following criteria at screening: Signs of facial/cervical gingival recession and/or signs of erosion or abrasion (EAR). Tooth with 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 (yes[Y]/No[N] response). Minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars), that meet all of the following criteria at screening: Tooth with signs of sensitivity, measured by response to a qualifying tactile stimulus (Yeaple ≤ 20g) and evaporative air assessment (Schiff sensitivity score ≥ 2). Exclusion Criteria: Women who are breast-feeding, known to be pregnant or who are intending to become pregnant over the duration of the study. Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients. Previous participation in this study or 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. Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes or causing xerostomia. Dental prophylaxis within 4 weeks of Screening. Tongue or lip piercing or presence of dental implants. 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 8 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 dentifrice. Use of an oral care product indicated for the relief of dentine hypersensitivity within 8 weeks of screening. Daily doses of medication/treatments which, in the opinion of the investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs. Currently taking antibiotics or has taken antibiotics within 2 weeks of Baseline. Daily dose of a medication which, in the opinion of the Investigator, is causing xerostomia.
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
Mississauga
State/Province
Ontario
ZIP/Postal Code
L4W 0C2
Country
Canada

12. IPD Sharing Statement

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Study to Investigate the Efficacy of an Occluding Dentifrice in Providing Relief From Dentine Hypersensitivity

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