Dentine HypersensitivityPhase 3NCT01592851

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

A Phase 3 study testing Stannous Fluoride and Sodium Monofluorophosphate in people with Dentine Hypersensitivity, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dentine Hypersensitivity
What is being tested?: Stannous Fluoride and Sodium Monofluorophosphate
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 113 participants
Where: 1 siteUnited States
Study dates: Apr 2012to May 2012
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 65 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Subjects who suffer from tooth sensitivity.

Trial locations and contacts

1 site in 1 country.

United States1 site

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

Other trials in United States

About this study

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

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

Conditions: Dentine Hypersensitivity
Being tested: Stannous Fluoride, Sodium Monofluorophosphate
Medical subject headings: Dentin Sensitivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Stannous FluorideDrug
dentifrice containing stannous fluoride
Sodium MonofluorophosphateDrug
dentifrice containing Sodium Monofluorophosphate

Study groups in NCT01592851
Study group	Role	What they receive
Arm 1	Experimental	Dentifrice containing stannous fluoride Receives: Drug: Stannous Fluoride
Arm 2	Active comparator	Marketed dentifrice containing Sodium Monofluorophosphate Receives: Drug: Sodium Monofluorophosphate

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Day 14

Secondary outcomes (5)

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.
Measured: Baseline to immediately post treatment administration
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.
Measured: Baseline to Day 3
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
Measured: Baseline to Day 14
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.
Measured: Baseline to Day 3
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.
Measured: Baseline to immediately post treatment administration

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 2012May 2012

First posted7 May 2012 (estimated)
Study startApr 2012
Primary completionMay 2012
Study completionMay 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Dentine HypersensitivityStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind
Who is masked: Investigator
Enrolment: 113 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01592851
Sponsor's protocol ID: RH01324
Status last verified: Feb 2014
First submitted: 3 May 2012
Last updated: 3 Jun 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 27093773

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study Investigating the Efficacy of a Dentifrice in Providing Short Term Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT01592851
Acronym / sponsor ID: RH01324
Conditions: Dentine Hypersensitivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 113 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 7 May 2012 (estimated)
Results: Posted 3 Jun 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Arm 1	Experimental	Drug: Stannous FluorideDentifrice containing stannous fluoride
Arm 2	Active comparator	Drug: Sodium MonofluorophosphateMarketed dentifrice containing Sodium Monofluorophosphate

Who may qualify

Ages: 18 to 65 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Stannous Fluoridedentifrice containing stannous fluoride	Drug	Arm 1
Sodium Monofluorophosphatedentifrice containing Sodium Monofluorophosphate	Drug	Arm 2

Primary outcome

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14
Time frame: Baseline to 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.

5 secondary outcomes

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale Immediately Post-treatment
Time frame: Baseline to immediately post treatment administration
Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 3
Time frame: Baseline to Day 3
Change From Baseline in Tactile Pain Threshold Score at Day 14
Time frame: Baseline to Day 14
Change From Baseline in Tactile Pain Threshold Score at Day 3
Time frame: Baseline to Day 3
Change From Baseline in Tactile Pain Threshold Score Immediately Post-treatment
Time frame: Baseline to immediately post treatment administration

Results and safety

Results posted to the registry on 3 Jun 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Stannous Fluoride (SnF) Dentifrice	56	56
Sodium Monofluorophosphate (NaMFP) Dentifrice	57	57

Primary outcome: Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14

Time frame: Baseline to Day 14. Mean (Standard Deviation). Unit: Score on a scale

Measure	SnF Dentifrice n = 56	NaMFP Dentifrice n = 57
Value	-1.20 (0.70)	-0.37 (0.43)

SnF Dentifrice vs NaMFP Dentifrice: Adjusted Mean Difference: -0.83 (95% CI -1.03 to -0.63), p <0.0001, ANCOVA

Population analysed: Intent To Treat (ITT) population: All randomized participants, who were administered with at least one study treatment during the study and provided at least one post-baseline assessment of efficacy.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All adverse events encountered or spontaneously reported following administration of any investigational product, or for up to 5 days after the last administration of investigational product were recorded.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
SnF Dentifrice	0 of 56 (0%)	0 of 56 (0%)	Not reported
NaMFP Dentifrice	0 of 57 (0%)	0 of 57 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 27093773Parkinson 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.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Stannous Fluoride and Sodium Monofluorophosphate in people with Dentine Hypersensitivity, run by GlaxoSmithKline at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 3 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline in Evaporative Air Sensitivity Pain Response on a Schiff Sensitivity Scale at Day 14 (time frame: Baseline to Day 14). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01592851, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2014.