Dentine HypersensitivityPhase 3NCT01827670

Investigating the Efficacy of a Dentifrice in Providing Long Term Relief From 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

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: 119 participants
Where: 1 siteUnited States
Study dates: Feb 2013to May 2013
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

Who may be able to join

Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
Participants with minimum of 20 natural teeth.
At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.
Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
Teeth with Gingival Index score ≤1 and a clinical mobility of ≤1.
Teeth that are determined to be sensitive by the subject following a 1 second air blast to the cervical margin.

Who cannot join

Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
Any condition which, in the opinion of the investigator, causes dry mouth.
Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
Participant using of a desensitising dentifrice within 6 weeks of screening

Trial locations and contacts

1 site in 1 country.

United States1 site

Salus Research, Inc.
Fort Wayne, Indiana, 46825

Other trials in United States

About this study

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

Clinical studies have demonstrated long term relief from dentine hypersensitivity with twice daily brushing of a toothpaste containing stannous fluoride in comparison to marketed (negative) controls. The aim of this study is to evaluate the effectiveness of a stannous fluoride dentifrice in the treatment of dentinal hypersensitivity compared to a marketed (negative) control, over a period of 56 days (8 weeks) with twice daily brushing.

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
Test dentifrice containing 0.454% SnF
Sodium monofluorophosphateDrug
Control dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]

Study groups in NCT01827670
Study group	Role	What they receive
0.454% stannous fluoride dentifrice	Experimental	Participants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water. Receives: Drug: Stannous fluoride
0.76% sodium monofluorophosphate dentifrice	Active comparator	Participants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water. Receives: Drug: Sodium monofluorophosphate

What is being measured

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

Mean Change From Baseline in Schiff Sensitivity Score
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).
Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Measured: Baseline-Week 8

Secondary outcomes (5)

Mean Change From Baseline in Schiff Sensitivity Score
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS).
Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation
Measured: Baseline-Week 4
Mean Change From Baseline in Tactile Sensitivity
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.
Measured: Baseline-Week 8
Mean Change From Baseline in Tactile Sensitivity
The examiner assessed the tactile sensitivity of eligible teeth using a Yeaple probe. The constant pressure applied by Yeaple probe probe allowed the examiner to vary the force applied to the dentin surface from 10g to an upper threshold of 80g, in increments of 10g. The greater the pressure the participant was able to tolerate, the less sensitive the tooth was considered. Testing began at 10g and increased by 10g, with each successive challenge, until either a "yes" response (pain was elicited) was recorded or the maximum force has been reached.
Measured: Baseline-Week 4
Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Measured: Baseline-Week 4
Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
The subject rated the intensity of their response to the evaporative air stimulus by rating the intensity of their response to the stimulus using a 100 millimeter (mm )VAS Scale 0 is No Pain and 100 is Worst Pain Imaginable A trained member of staff measured the line segment marked off in mm and recorded this measurement in the CRF
Measured: Baseline - Week 8

Timeline

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

Feb 2013May 2013

First posted9 Apr 2013 (estimated)
Study startFeb 2013
Primary completionMay 2013
Study completionMay 2013

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: 119 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01827670
Sponsor's protocol ID: RH01685
Status last verified: Jan 2015
First submitted: 5 Apr 2013
Last updated: 26 Jan 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6.
PubMed 26437498

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?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2015. 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 Long Term Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT01827670
Acronym / sponsor ID: RH01685
Conditions: Dentine Hypersensitivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 119 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2013
Primary completion: May 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 Apr 2013 (estimated)
Results: Posted 26 Jan 2015

Clinical summary

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

Study design

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

Arm	Type	Receives
0.454% stannous fluoride dentifrice	Experimental	Drug: Stannous fluorideParticipants to brush whole mouth with 1-inch strip of the test dentifrice (0.454% SnF) for one timed minute, followed by rinsing with 5 milliliter (mL) of water.
0.76% sodium monofluorophosphate dentifrice	Active comparator	Drug: Sodium monofluorophosphateParticipants to brush whole mouth with 1-inch strip of the control dentifrice (0.76% NaMFP) for one timed minute, followed by rinsing with 5 mL of water.

Who may qualify

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

Key inclusion criteria (6 listed)

Participants with self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years.
Participants with minimum of 20 natural teeth.
At screening, a minimum of two accessible teeth (incisors, canines, premolars) that meet all of the following criteria.

Key exclusion criteria (4 listed)

Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.
Any condition which, in the opinion of the investigator, causes dry mouth.
Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
Participant using of a desensitising dentifrice within 6 weeks of screening

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 fluorideTest dentifrice containing 0.454% SnF	Drug	0.454% stannous fluoride dentifrice
Sodium monofluorophosphateControl dentifrice containing 0.76% w/w Sodium Monofluorophosphate [1000 parts per million (ppm) fluoride]	Drug	0.76% sodium monofluorophosphate dentifrice

Primary outcome

Mean Change From Baseline in Schiff Sensitivity Score
Time frame: Baseline-Week 8
The examiner conducted the evaporative air sensitivity assessment and scored the subject's response to the sensitivity stimulus using the four-point categorical Schiff Sensitivity Scale (SSS). Score 0 = Subject does not respond to air stimulus Score 1 = Subject responds to air stimulus, but does not request discontinuation of stimulus Score 2 = Subject responds to air stimulus, and requests discontinuation or moves from stimulus Score 3 = Subject responds to air stimulus, considers stimulus to be painful, and requests discontinuation

5 secondary outcomes

Mean Change From Baseline in Schiff Sensitivity Score
Time frame: Baseline-Week 4
Mean Change From Baseline in Tactile Sensitivity
Time frame: Baseline-Week 8
Mean Change From Baseline in Tactile Sensitivity
Time frame: Baseline-Week 4
Mean Change in Dentinal Hypersensitivity After 4 Weeks as Measured by Visual Analog Scale (VAS)
Time frame: Baseline-Week 4
Mean Change in Dentinal Hypersensitivity After 8 Weeks as Measured by Visual Analog Scale (VAS)
Time frame: Baseline - Week 8

Results and safety

Results posted to the registry on 26 Jan 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Control Dentifrice (0.76% Sodium Monofluorophosphate)	60	57
Test Dentifrice (0.454% Stannous Fluoride)	59	56

Primary outcome: Mean Change From Baseline in Schiff Sensitivity Score

Time frame: Baseline-Week 8. Mean (Standard Deviation). Unit: Score on a scale

Measure	Control Dentrifice (0.76% Sodium Monofluorophosphate) n = 57	Test Dentrifice (0.454% Stannous Fluoride) n = 57
Schiff Sensitivity Score at Baseline	2.26 (0.379)	2.25 (0.355)
Schiff Sensitivity Score at Week 8	2.09 (0.628)	0.78 (0.687)

Control Dentrifice (0.76% Sodium Monofluorophosphate) vs Test Dentrifice (0.454% Stannous Fluoride): Adjusted Mean: -1.29 (95% CI -1.53 to -1.06), p <0.0001, ANCOVA

Population analysed: Efficacy assessments were based on intent-to-treat (ITT) population, defined as all randomized participants, administered at least one dose of study treatment providing at least one post-baseline assessment of efficacy. One participant was lost to follow-up after visit 2 in test dentifrice group but was included in the efficacy analysis at visit 2

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: All Adverse events encountered or spontaneously reported following use of dentifices were reported at Baseline visit(Visit 2), 28 days(Visit 3) and Visit 4(Day 56). Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Control Dentifrice (0.76% Sodium Monofluorophosphate)	0 of 60 (0%)	2 of 60 (3.3%)	Not reported
Test Dentifrice (0.454% Stannous Fluoride)	0 of 59 (0%)	1 of 59 (1.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 26437498Parkinson CR, Jeffery P, Milleman JL, Milleman KR, Mason S. Confirmation of efficacy in providing relief from the pain of dentin hypersensitivity of an anhydrous dentifrice containing 0.454% with or without stannous fluoride in an 8-week randomized clinical trial. Am J Dent. 2015 Aug;28(4):190-6.

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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?

The sponsor lists 6 inclusion and 4 exclusion criteria. 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 26 Jan 2015. 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 26 Jan 2015). 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?

Mean Change From Baseline in Schiff Sensitivity Score (time frame: Baseline-Week 8). 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 NCT01827670, 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 26 Jan 2015.