NCT01592851

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Apr 2012

Shorter than P25 for phase_3

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

May 3, 2012

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

June 3, 2014

Completed
Last Updated

June 3, 2014

Status Verified

February 1, 2014

Enrollment Period

1 month

First QC Date

May 3, 2012

Results QC Date

April 5, 2013

Last Update Submit

May 1, 2014

Conditions

Dentine Hypersensitivity

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (5)

  • Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment

    Baseline to immediately post treatment administration

  • Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3

    Baseline to Day 3

  • Change From Baseline in Tactile Pain Threshold Score at Day 14

    Baseline to Day 14

  • Change From Baseline in Tactile Pain Threshold Score at Day 3

    Baseline to Day 3

  • Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment

    Baseline to immediately post treatment administration

Study Arms (2)

Arm 1

EXPERIMENTAL

Dentifrice containing stannous fluoride

Drug: Stannous Fluoride

Arm 2

ACTIVE COMPARATOR

Marketed dentifrice containing Sodium Monofluorophosphate

Drug: Sodium Monofluorophosphate

Interventions

Stannous FluorideDRUG

dentifrice containing stannous fluoride

Arm 1
Sodium MonofluorophosphateDRUG

dentifrice containing Sodium Monofluorophosphate

Arm 2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
\- Subjects who suffer from tooth sensitivity.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (1)

BioSci Research America, Inc.

Las Vegas, Nevada, 89121, United States

Location

Related Publications (1)

  • 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.

    PMID: 27093773DERIVED

MeSH Terms

Conditions

Dentin Sensitivity

Interventions

Tin Fluoridesfluorophosphate

Condition Hierarchy (Ancestors)

Tooth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

FluoridesHydrofluoric AcidFluorine CompoundsInorganic ChemicalsTin CompoundsCariostatic AgentsBiomedical and Dental MaterialsManufactured MaterialsTechnology, Industry, and Agriculture

Results Point of Contact

Title
GSK Response Center
Organization
GlaxoSmithKline
866-435-7343

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

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

April 1, 2012

Primary Completion

May 1, 2012

Study Completion

May 1, 2012

Last Updated

June 3, 2014

Results First Posted

June 3, 2014

Record last verified: 2014-02

Locations

US(1)