The Efficacy of a Dentifrice in Providing Relief From the Pain of Dentinal Hypersensitivity
A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From Dentinal Hypersensitivity
1 other identifier
interventional
120
1 country
1
Brief Summary
A study to compare the efficacy of a test dentifrice against a control dentifrice in reducing dentinal hypersensitivity over an eight week treatment period.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Mar 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2012
CompletedFirst Submitted
Initial submission to the registry
May 3, 2012
CompletedFirst Posted
Study publicly available on registry
May 7, 2012
CompletedResults Posted
Study results publicly available
March 10, 2014
CompletedMarch 10, 2014
December 1, 2013
2 months
May 3, 2012
May 16, 2013
February 6, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 8
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.
Baseline to 8 weeks post administration of study treatment
Secondary Outcomes (3)
Mean Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Week 4
Baseline to 4 weeks post administration of study treatment
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 8
Baseline to 8 weeks post administration of study treatment
Adjusted Mean Change From Baseline in Tactile Sensitivity Pain Response at Week 4
Baseline to 4 weeks post administration of study treatment
Study Arms (2)
Arm 1
EXPERIMENTALDentifrice containing stannous fluoride
Arm 2
ACTIVE COMPARATORMarketed dentifrice containing Sodium Monofluorophosphate
Interventions
Eligibility Criteria
You may qualify if:
- Subjects who suffer from tooth sensitivity
- \- none
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- GlaxoSmithKlinelead
Study Sites (1)
BioSci Research America, Inc.
Las Vegas, Nevada, 89121, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- GSK Response Center
- Organization
- GlaxoSmithKline
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 3, 2012
First Posted
May 7, 2012
Study Start
March 1, 2012
Primary Completion
May 1, 2012
Study Completion
May 1, 2012
Last Updated
March 10, 2014
Results First Posted
March 10, 2014
Record last verified: 2013-12