Dentinal SensitivityNCT01494649

Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

A study testing Test Toothpaste in people with Dentinal Sensitivity and 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 pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dentinal Sensitivity, Hypersensitivity
What is being tested?: Test Toothpaste
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 118 participants
Where: 1 siteUnited States
Study dates: Sep 2011to Sep 2011
Phase: Interventional
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

Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
Teeth having a gingival index score of less than or equal to 1
Teeth with a clinical mobility less than or equal to 1
sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Who cannot join

Presence of chronic debilitating disease which could affect study outcomes.
Any condition which 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.

Show all 12Show fewer

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, or not expected to respond to treatment with an over-the counter dentifrice.
Daily doses of a medication which could interfere with the perception of pain.
Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
Individuals who require antibiotic prophylaxis for dental procedures.

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 Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

Conditions: Dentinal Sensitivity, Hypersensitivity
Being tested: Test Toothpaste, Negative Control Toothpaste
Keywords: dentinal, hypersensitivity
Medical subject headings: Hypersensitivity

What participants receive

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

Test ToothpasteDrug
0.454% stannous fluoride toothpaste
Negative Control ToothpasteDrug
0.76% sodium monofluorophosphate toothpaste

Study groups in NCT01494649
Study group	Role	What they receive
Toothpaste containing 0.454% stannous fluoride	Active comparator	USA marketed toothpaste [test] Receives: Drug: Test Toothpaste
Toothpaste containing 0.76% sodium monofluorophosphate	Other	USA marketed toothpaste [negative control] Receives: Drug: Negative Control Toothpaste

What is being measured

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

Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.
Measured: Baseline and immediately after treatment administration

Secondary outcomes (5)

Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 3 minus Schiff score at baseline.
Measured: Baseline and Day 3
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity). 0=No participant response to stimulus, 1=responds but will continue, 2=responds and moves or requests discontinuation, 3=Painful response to stimulus, discontinuation requested. Change was Schiff score on Day 14 minus Schiff score at baseline.
Measured: Baseline and Day 14
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score immediately after treatment minus mean score at baseline.
Measured: Baseline and immediately after treatment administration
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 3 minus mean score at baseline.
Measured: Baseline and Day 3
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
Measured with an electronic force sensing probe (Yeaple Probe): 10, 20, 30, 40, up to 80 grams of force applied to hypersensitive tooth until pain was elicited. Grams of force needed to elicit pain was recorded as hypersensitivity score for the tooth. The higher the score, the lower the hypersensitivity. Hypersensitivity scores on a per study participant basis was recorded as mean scores of all hypersensitive teeth. Change was calculated as mean score at Day 14 minus mean score at baseline.
Measured: Baseline and Day 14

Timeline

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

Sep 2011Sep 2011

First posted19 Dec 2011 (estimated)
Study startSep 2011
Primary completionSep 2011
Study completionSep 2011

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 Dentinal SensitivityStudies 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 N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 118 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01494649
Sponsor's protocol ID: Z7871335
Status last verified: Aug 2012
First submitted: 1 Sep 2011
Last updated: 8 May 2013
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

RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Not yet recruiting
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
Not yet recruiting
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Dentinal Hypersensitivity
Not yet recruiting
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
Dentistry, Desensitization

All Dentinal Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Pilot Clinical Study Investigating the Efficacy of a Toothpaste in Providing Immediate and Short Term Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT01494649
Acronym / sponsor ID: Z7871335
Conditions: Dentinal Sensitivity, Hypersensitivity
Keywords: dentinal, hypersensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 118 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2011
Primary completion: Sep 2011 (actual)
Study completion: Sep 2011 (actual)
First posted: 19 Dec 2011 (estimated)
Results: Posted 8 May 2013

Clinical summary

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

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

Study design

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

Arm	Type	Receives
Toothpaste containing 0.454% stannous fluoride	Active comparator	Drug: Test ToothpasteUSA marketed toothpaste [test]
Toothpaste containing 0.76% sodium monofluorophosphate	Other	Drug: Negative Control ToothpasteUSA marketed toothpaste [negative control]

Who may qualify

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

Key inclusion criteria (5 listed)

Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
Teeth having a gingival index score of less than or equal to 1
Teeth with a clinical mobility less than or equal to 1
sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Key exclusion criteria (12 listed)

Presence of chronic debilitating disease which could affect study outcomes.
Any condition which 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.

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
Test Toothpaste0.454% stannous fluoride toothpaste	Drug	Toothpaste containing 0.454% stannous fluoride
Negative Control Toothpaste0.76% sodium monofluorophosphate toothpaste	Drug	Toothpaste containing 0.76% sodium monofluorophosphate

Primary outcome

Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment
Time frame: Baseline and immediately after treatment administration
Response to a constant (duration, pressure, temperature, distance from target) jet of air applied to a hypersensitive tooth was evaluated using Schiff Cold Air Sensitivity Scale. According to this analog scale hypersensitivity scores for the stimulated tooth is 0, 1, 2 or 3 (lower the score, lower the hypersensitivity).0= no response; 1= response and no discontinuation request; 2= response and discontinuation request; 3= painful response and discontinuation request. Change was calculated as Schiff score immediately after treatment minus Schiff score at baseline.

5 secondary outcomes

Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 3
Time frame: Baseline and Day 3
Adjusted Mean Change From Baseline in Tooth Hypersensitivity to Air Stimuli at Day 14
Time frame: Baseline and Day 14
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately After Treatment
Time frame: Baseline and immediately after treatment administration
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 3
Time frame: Baseline and Day 3
Adjusted Mean Change From Baseline in Tooth Hypersensitity to Touch Stimuli (Tactile) Immediately at Day 14
Time frame: Baseline and Day 14

Results and safety

Results posted to the registry on 8 May 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Test	59	59
Negative Control	59	58

Primary outcome: Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment

Time frame: Baseline and immediately after treatment administration. Mean (95% Confidence Interval). Unit: units on a scale

Measure	Test n = 59	Negative Control n = 59
Value	-0.42 (-0.53 to -0.30)	-0.32 (-0.43 to -0.21)

Test vs Negative Control: Adjusted mean difference: -0.10 (95% CI -0.26 to 0.06), p = 0.2294, ANCOVA

Population analysed: Intent to treat (ITT) population: All participants who were randomized, receive at least one dose of treatment, and had at least one post baseline efficacy evaluation. No data was imputed in the case of dropouts or missing data.

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 5 days post administration of last treatment. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test	0 of 59 (0%)	0 of 59 (0%)	Not reported
Negative Control	0 of 59 (0%)	0 of 59 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
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.

Related trials for Dentinal Sensitivity

RecruitingPhase 3
Comparative Efficacy of Different Dentin Occluding Toothpaste Technologies
Dentinal Sensitivity, Dentinal Hypersensitivity
Not yet recruitingPhase 2/3
Gluma Compared With Bonding Agent for Post-operative Sensitivity Following Composite Restorations
Post-operative Sensitivity, Dentin Hypersensitivity
Not yet recruiting
Comparative Efficacy of Laser Systems and Fluoride in Managing Dentinal Hypersensitivity: RCT
Dentin Sensitivity, Dentine Hypersensitivity, Tooth Sensitivity
Not yet recruiting
Comparison of LASER Therapy and Desensitizing Agents in Dentinal Hypersensitivity
Dentinal Hypersensitivity
Not yet recruiting
Potassium Nitrate Gel and Diode Laser in the Treatment of Dentinal Hypersensitivity
Dentistry, Desensitization

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 study testing Test Toothpaste in people with Dentinal Sensitivity and 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 5 inclusion and 12 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 8 May 2013. 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.

Are results available for this study?

Yes. Results are posted in the registry (first posted 8 May 2013). 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?

Adjusted Mean Change From Baseline in Tooth Hypersensivity to Air Stimuli Immediately Following Treatment (time frame: Baseline and immediately after treatment administration). 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 NCT01494649, 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 8 May 2013.