Dentine HypersensitivityPhase 3NCT03072719

The Efficacy of a Dentifrice in Providing Relief From Immediate and Short 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 Ireland.

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 randomised, examiner blind, two treatment arm, stratified, parallel design, single-site study in subjects with at least two sensitive teeth to compare the efficacy of a test dentifrice against that of a control dentifrice in reducing dentinal hypersensitivity. 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: 120 participants
Where: 1 siteIreland
Study dates: 1 Mar 2012to 12 Jun 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

Who may be able to join

Demonstrates understanding of the study and willingness to participate
Aged at least 18 to 65 years
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years
Minimum of 20 natural teeth at screening, a minimum of two accessible teeth (incisors, canines, pre-molars)
At baseline, participant has two non-adjacent sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity measured by tactile stimulus (Yeaple ≤ 20g) and evaporative (air) assessment (Schiff Sensitivity Score ≥ 2) at baseline

Who cannot join

Pregnant or breast-feeding women
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Recent history (within the last year) of alcohol or other substance abuse
An employee of the sponsor or the study site or members of their immediate family
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

Show all 21Show fewer

Any condition which, in the opinion of the investigator, causes xerostomia
Dental prophylaxis within 4 weeks of screening
Tongue or lip piercing or presence of dental implants
Professional desensitising treatment within 12 weeks of screening
Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
Teeth bleaching within 12 weeks of screening
Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening
Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine
Sensitive tooth not expected to respond to treatment with an over-the counter dentifrice in the opinion of the investigator.
Use of a desensitising dentifrice within six weeks of screening (participant will be required to bring their current dentifrice to the site in order to verify the lack of known anti-sensitivity ingredients)
Daily doses of a medication which, in the opinion of the investigator, could interfere with the perception of pain
Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
Daily doses of a medication which, in the opinion of the investigator, causes xerostomia
Individuals who require antibiotic prophylaxis for dental procedures
Any participant who, in the judgment of the investigator, should not participate in the study.

Trial locations and contacts

1 site in 1 country.

Ireland1 site

GSK Investigational Site
Cork

Other trials in Ireland

About this study

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

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, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.
Sodium MonofluorophosphateDrug
Control dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.

Study groups in NCT03072719
Study group	Role	What they receive
Dentifrice containing stannous fluoride	Experimental	Toothpaste Receives: Drug: Stannous Fluoride
Dentifrice containing Sodium Monofluorophosphate	Active comparator	Toothpaste 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 Schiff Sensitivity Score on Day 14
Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.
Measured: Baseline, Day 14

Secondary outcomes (2)

Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicate improvement in sensitivity.
Measured: Baseline, post first brushing (after 5 minutes) and Day 3
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14
Tactile threshold was assessed by examiner using a constant pressure probe (Yeaple probe) which allowed application of a known force to the dentin surface from 10 g to an upper threshold of 80g in increments of 10 g. The tactile threshold is the maximum pressure applied at which participant do not report any pain or discomfort. The tactile threshold for each tooth was determined by asking the participant whether the sensation caused discomfort. The pressure setting at which the participant gave two consecutive 'yes' responses was recorded as the tactile threshold. The higher the tactile threshold, the less sensitive the tooth.
Measured: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

Timeline

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

1 Mar 201212 Jun 2012

First posted7 Mar 2017
Study start1 Mar 2012
Primary completion1 Jun 2012
Study completion12 Jun 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: Double blind
Who is masked: Participant, Outcomes assessor
Enrolment: 120 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03072719
Sponsor's protocol ID: 202161
Other IDs: RH01327
Status last verified: Feb 2018
First submitted: 2 Mar 2017
Last updated: 6 Mar 2018
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 6 Mar 2018. 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 Immediate and Short Term Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT03072719
Acronym / sponsor ID: 202161
Conditions: Dentine Hypersensitivity
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 120 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Mar 2012 (actual)
Primary completion: 1 Jun 2012 (actual)
Study completion: 12 Jun 2012 (actual)
First posted: 7 Mar 2017 (actual)
Results: Posted 18 Apr 2017

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: Double blind (participant, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Dentifrice containing stannous fluoride	Experimental	Drug: Stannous FluorideToothpaste
Dentifrice containing Sodium Monofluorophosphate	Active comparator	Drug: Sodium MonofluorophosphateToothpaste

Who may qualify

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

Key inclusion criteria (7 listed)

Demonstrates understanding of the study and willingness to participate
Aged at least 18 to 65 years
Understands and is willing, able and likely to comply with all study procedures and restrictions
Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history or oral examination.
Self-reported history of dentinal hypersensitivity lasting more than 6 months but not more than 10 years

Key exclusion criteria (21 listed)

Pregnant or breast-feeding women
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients.
Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit
Recent history (within the last year) of alcohol or other substance abuse
An employee of the sponsor or the study site or members of their immediate family

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, participants will brush each of the 2 selected sensitive teeth each for 30 seconds followed by the whole mouth thoroughly for at least one minute.	Drug	Dentifrice containing stannous fluoride
Sodium MonofluorophosphateControl dentifrice, participants will brush the whole mouth thoroughly for at least 1 minute.	Drug	Dentifrice containing Sodium Monofluorophosphate

Primary outcome

Change From Baseline in Schiff Sensitivity Score on Day 14
Time frame: Baseline, Day 14
Schiff sensitivity score was assessed by examiner as participant's response to an evaporative (air) stimulus after the stimulation of each individual tooth. Response of participant was scored using Schiff sensitivity scale range of 0-3; 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 requests discontinuation or moves from stimulus; 3= Participant responds to stimulus, considers stimulus to be painful, and requests discontinuation of the stimulus. A reduction in Schiff Sensitivity score indicates improvement in sensitivity.

2 secondary outcomes

Change From Baseline in Schiff Sensitivity Score on Post First Brushing (After 5 Minutes) and Day 3
Time frame: Baseline, post first brushing (after 5 minutes) and Day 3
Change From Baseline in Tactile (Yeaple) Pain Threshold on Post First Brushing (After 5 Minutes), Day 3 and Day 14
Time frame: Baseline, post first brushing (after 5 minutes), Day 3 and Day 14

Results and safety

Results posted to the registry on 18 Apr 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Experimental Dentifrice	60	59
Reference Dentifrice	60	59

Primary outcome: Change From Baseline in Schiff Sensitivity Score on Day 14

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

Measure	Experimental Dentifrice n = 60	Reference Dentifrice n = 60
At Baseline	2.51 (0.437)	2.51 (0.446)
At Day 14	1.16 (0.774)	1.35 (0.901)
Change from Baseline on Day 14	-1.35 (0.727)	-1.16 (0.762)

Experimental Dentifrice vs Reference Dentifrice: Least square (LS) mean difference: -0.19 (95% CI -0.46 to 0.09), p = 0.1774, ANCOVA

Population analysed: Analysis for this outcome was conducted on intent-to-treat (ITT) population which included all randomized participants who had at least one post baseline assessment of efficacy. n is the number of participants evaluated at specific time point for treatment arms respectively.

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Experimental Dentifrice	0 of 60 (0%)	9 of 60 (15%)	0 of 60
Reference Dentifrice	0 of 60 (0%)	8 of 60 (13.3%)	0 of 60

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2018.
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 Ireland.

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 7 inclusion and 21 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 6 Mar 2018. 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 Ireland. 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 18 Apr 2017). 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 Schiff Sensitivity Score on Day 14 (time frame: Baseline, 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 NCT03072719, 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 6 Mar 2018.