Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity

Dentine Hypersensitivity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592851
• Other study ID #: RH01324
• Status: Completed
• Phase: Phase 3
• First received: May 3, 2012
• Last updated: May 1, 2014
• Start date: April 2012
• Est. completion date: May 2012

Study information

• Verified date: February 2014
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over a two week treatment period.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 113
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 65 Years
• Eligibility: - Subjects who suffer from tooth sensitivity.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dentin Sensitivity
• Dentine Hypersensitivity
• Hypersensitivity

Intervention

Drug:
• Stannous Fluoride
dentifrice containing stannous fluoride
• Sodium Monofluorophosphate
dentifrice containing Sodium Monofluorophosphate

Locations

Country	Name	City	State
United States	BioSci Research America, Inc.	Las Vegas	Nevada

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14	Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold = 20g) were assessed at baseline and Day 14. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.	Baseline to Day 14	No
Secondary	Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment	Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold = 20g) were assessed at baseline and immediately after treatment. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.	Baseline to immediately post treatment administration	No
Secondary	Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3	Response to a constant jet of air applied to hypersensitive teeth is evaluated using a Schiff Sensitivity pain response scale. According to this analog scale, pain response for each individual stimulated tooth ranged from 0 to 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 request discontinuation of stimulus, 3 - participant responds to air stimulus, considers stimulus to be painful and request discontinuation of stimulus. Those teeth that met the tactile threshold inclusion criterion (tactile threshold = 20g) were assessed at baseline and Day 3. The Investigator directed a second application of air from a standard dental syringe to the facial surface of the two sensitive teeth selected at baseline. The Schiff Sensitivity Score was calculated as the subject level mean change (on two teeth) from baseline.	Baseline to Day 3	No
Secondary	Change From Baseline in Tactile Pain Threshold Score at Day 14	The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity	Baseline to Day 14	No
Secondary	Change From Baseline in Tactile Pain Threshold Score at Day 3	The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.	Baseline to Day 3	No
Secondary	Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment	The Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale (10g to 80g). According to this tactile sensitivity assessment, an increasing force is applied to hypersensitive tooth until a yes response to pain is recorded or the maximum force has been reached. Tactile testing begins with a force of 10g and it is increased by 10g, with each successive challenge, until either a "yes" response is recorded or the maximum force (80g) is reached. An increase in tactile score from baseline represents an improvement in sensitivity.	Baseline to immediately post treatment administration	No