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

Phase 3

Completed

• Conditions: Dentine Hypersensitivity
• Interventions: Drug: Stannous Fluoride; Drug: Sodium Monofluorophosphate

• Registration Number: NCT03072719
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2012-03-01
• Primary Completion: 2012-06-01
• Study Completion: 2012-06-12
• Study First Submitted: 2017-03-02
• Study First Submitted QC: 2017-03-02
• Study First Posted: 2017-03-07
• Results First Submitted: 2017-03-07
• Results First Submitted QC: 2017-03-07
• Results First Posted: 2017-04-18
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dentifrice containing stannous fluoride	Stannous Fluoride	Toothpaste
Dentifrice containing Sodium Monofluorophosphate	Sodium Monofluorophosphate	Toothpaste

Primary Outcome Measures

Name	Time	Method
Change From Baseline in Schiff Sensitivity Score on Day 14	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14	Baseline, 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.
Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3	Baseline, 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.

Trial Locations

Locations (1)

GSK Investigational Site; 🇮🇪 Cork, Ireland