Clinical Efficacy of a Toothpaste in Providing Relief From the Pain of Dentinal Hypersensitivity - Full Text View

Purpose

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

Condition	Intervention	Phase
Dentine Hypersensitivity	Drug: Stannous Fluoride Drug: Sodium Monofluorophosphate	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity

Resource links provided by NLM:

MedlinePlus related topics: Allergy

Drug Information available for: Sodium monofluorophosphate Fluorine Stannous fluoride Fluoride

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:

Evaporative air sensitivity pain response on a Schiff sensitivity scale at Day 14 [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
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.

Secondary Outcome Measures:

Evaporative air sensitivity pain response on a Schiff sensitivity scale immediately post treatment [ Time Frame: Baseline to immediately post treatment administration ] [ Designated as safety issue: No ]
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.
Evaporative air sensitivity pain response on a Schiff sensitivity scale at Day 3 [ Time Frame: Baseline to Day 3 ] [ Designated as safety issue: No ]
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.
Tactile Pain Threshold Score at Day 14 [ Time Frame: Baseline to Day 14 ] [ Designated as safety issue: No ]
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Tactile Pain Threshold Score at Day 3 [ Time Frame: Baseline to Day 3 ] [ Designated as safety issue: No ]
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.
Tactile Pain Threshold Score immediately post treatment [ Time Frame: Baseline to immediately post treatment administration ] [ Designated as safety issue: No ]
Response to increasing force on hypersensitive teeth was evaluated using a Yeaple Probe pain response scale. According to this tactile sensitivity assessment, an increasing force was applied to hypersensitive tooth until a yes response is recorded or the maximum force has been reached.

Enrollment:	113
Study Start Date:	April 2012
Study Completion Date:	May 2012
Primary Completion Date:	May 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1 Dentifrice containing stannous fluoride	Drug: Stannous Fluoride dentifrice containing stannous fluoride
Active Comparator: Arm 2 Marketed dentifrice containing Sodium Monofluorophosphate	Drug: Sodium Monofluorophosphate dentifrice containing Sodium Monofluorophosphate

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

- Subjects who suffer from tooth sensitivity.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592851

Locations

United States, Nevada
BioSci Research America, Inc.
Las Vegas, Nevada, United States, 89121

Sponsors and Collaborators

GlaxoSmithKline

Investigators

Study Director:

GSK Clinical Trials

GlaxoSmithKline

More Information

No publications provided

Responsible Party:	GlaxoSmithKline
ClinicalTrials.gov Identifier:	NCT01592851 History of Changes
Other Study ID Numbers:	RH01324
Study First Received:	May 3, 2012
Last Updated:	February 7, 2013
Health Authority:	United States: Food and Drug Administration

Additional relevant MeSH terms:

Dentin Sensitivity
Hypersensitivity
Tooth Diseases
Stomatognathic Diseases
Immune System Diseases
Fluorides

Tin Fluorides
Fluorophosphate
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013