The Efficacy of a Dentifrice in Providing Relief From Immediate and Short Term Relief From Dentinal Hypersensitivity

A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity

A randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity.

Study Overview

• Status: Completed
• Conditions: Dentine Hypersensitivity
• Intervention / Treatment: Drug: Stannous Fluoride; Drug: Sodium Monofluorophosphate

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 3

Contacts and Locations

Study Locations

• Ireland
  • Cork, Ireland
    • GSK Investigational Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion

• Demonstrates understanding of the study and willingness to participate
• Aged at least 18 to 65 years
• Understands and is willing, able and likely to comply with all study procedures and restrictions
• Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
• Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
• Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
• At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

Exclusion

• Pregnant or breast-feeding women
• 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 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
• An employee of the sponsor or the study site or members of their immediate family
• 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
• Dental prophylaxis within 4 weeks of screening
• Tongue or lip piercing or presence of dental implants
• Professional desensitising treatment within 12 weeks of screening
• 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 12 weeks of screening
• Tooth with evidence of current or recent caries, or reported treatment of decay in 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 in the opinion of the investigator.
• Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
• Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
• Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
• Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
• Individuals who require antibiotic prophylaxis for dental procedures
• Any participant who, in the judgment of the investigator, should not participate in the study.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dentifrice containing stannous fluoride; Toothpaste	Drug: Stannous Fluoride; Test dentifrice, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
Active Comparator: Dentifrice containing Sodium Monofluorophosphate; Toothpaste	Drug: Sodium Monofluorophosphate; Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Schiff Sensitivity Score on Day 14	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.	Baseline, Day 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3	Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.	Baseline, post first brushing (after 5 minutes) and Day 3
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14	Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.	Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

Collaborators and Investigators

• Sponsor: GlaxoSmithKline

Publications and helpful links

General Publications

• Parkinson CR, Hughes N, Hall C, Whelton H, Gallob J, Mason S. Three randomized clinical trials to assess the short-term efficacy of anhydrous 0.454% w/w stannous fluoride dentifrices for the relief of dentin hypersensitivity. Am J Dent. 2016 Feb;29(1):25-32.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2012
• Primary Completion (Actual): June 1, 2012
• Study Completion (Actual): June 12, 2012

Study Registration Dates

• First Submitted: March 2, 2017
• First Submitted That Met QC Criteria: March 2, 2017
• First Posted (Actual): March 7, 2017

Study Record Updates

• Last Update Posted (Actual): March 6, 2018
• Last Update Submitted That Met QC Criteria: February 5, 2018
• Last Verified: February 1, 2018

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: 202161; RH01327 (Other Identifier: GSK)