Dentin SensitivityNCT02705716

Study Investigating Efficacy of an Occluding Dentifrice for Dentine Hypersensitivity

A study testing 0.454% w/w stannous fluoride (1100ppm fluoride) and 0.76% sodium monofluorophosphate (1000ppm fluoride) in people with Dentin Sensitivity, run by GlaxoSmithKline at 3 sites in United Kingdom.

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

This study will investigate the efficacy of an experimental dentifrice containing 0.454% weight/weight (w/w) stannous fluoride in relieving dentine hypersensitivity (DH) after twice daily brushing, over a 2 week treatment period compared with a standard fluoride dentifrice. Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Sensitivity
What is being tested?: 0.454% w/w stannous fluoride (1100ppm fluoride) and 0.76% sodium monofluorophosphate (1000ppm fluoride)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 409 participants
Where: 3 sitesUnited Kingdom
Study dates: 1 Mar 2016to 20 May 2016
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

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Participant is male or female aged between 18 and 65 years inclusive.
Good general and mental health with, in the opinion of the investigator or medically qualified designee.
No clinically significant and relevant abnormalities in medical history or upon oral examination.
Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements.
Self-reported history of dentinal hypersensitivity (DH) lasting more than(>) six months but not > 10 years.
Good general oral health, with a minimum of 20 natural teeth.
Minimum of 2 accessible non-adjacent teeth (incisors, canines, pre-molars), preferably in different quadrants at screening and minimum of two, non-adjacent accessible teeth (incisors, canines, pre-molars) at baseline.

Who cannot join

Women who are pregnant or breast-feeding .
Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.
Presence of chronic debilitating disease which, in the opinion of the investigator, could affect study outcomes.

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Any condition which, in the opinion of the investigator, causes xerostomia.
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 (including cosmetic studies) or receipt of an investigational drug within 30 days of the screening visit.
Previous participation in this study.
Recent history (within the last year) of alcohol or other substance abuse.
Dental prophylaxis within four weeks of Screening, tongue or lip piercing or presence of dental implants.
Desensitizing treatment within eight weeks of Screening (professional sensitivity treatments and non-toothpaste sensitivity treatments).
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 eight weeks of Screening.
Tooth with evidence of current or recent caries, or reported treatment of decay within 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 toothpaste in the opinion of the Investigator.
Use of an oral care product indicated for the relief of dentine hypersensitivity within eight weeks of screening.
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

3 sites in 1 country.

United Kingdom3 sites

GSK Investigational Site
Ellesmere Port, Cheshire, CH65 4BW
GSK Investigational Site
Manchester, M16 9HQ
GSK Investigational Site
Metropolitan Borough of Wirral, CH41 6EY

Other trials in United Kingdom

About this study

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

Conditions: Dentin Sensitivity
Being tested: 0.454% w/w stannous fluoride (1100ppm fluoride), 0.76% sodium monofluorophosphate (1000ppm fluoride)
Medical subject headings: Dentin Sensitivity

What participants receive

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

0.454% w/w stannous fluoride (1100ppm fluoride)Other
Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)
0.76% sodium monofluorophosphate (1000ppm fluoride)Other
Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)

Study groups in NCT02705716
Study group	Role	What they receive
Test Dentifrice	Experimental	Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants will then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute. Receives: Other: 0.454% w/w stannous fluoride (1100ppm fluoride)
Control Dentifrice	Placebo comparator	Participants will be instructed to apply a full brush head of toothpaste containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants will then brush the whole mouth thoroughly for at least 1 minute. Receives: Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)

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 Day 7
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 7
Change From Baseline in Tactile Threshold on Day 7 and 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, Day 7 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 201620 May 2016

First posted10 Mar 2016 (estimated)
Study start1 Mar 2016
Primary completion20 May 2016
Study completion20 May 2016

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.
Other trials for Dentin 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: Single blind
Who is masked: Investigator
Enrolment: 409 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02705716
Sponsor's protocol ID: 205212
Status last verified: Apr 2017
First submitted: 7 Mar 2016
Last updated: 25 Apr 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

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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A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Clinical Evaluation of Short Dentin Etching
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All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Short Term Clinical Study Investigating the Efficacy of an Occluding Dentifrice in Providing Relief From Dentinal Hypersensitivity
ClinicalTrials.gov ID: NCT02705716
Acronym / sponsor ID: 205212
Conditions: Dentin Sensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 409 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 1 Mar 2016
Primary completion: 20 May 2016 (actual)
Study completion: 20 May 2016 (actual)
First posted: 10 Mar 2016 (estimated)
Results: Posted 25 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: Single blind (investigator)
Number of arms: 2

Arm	Type	Receives
Test Dentifrice	Experimental	Other: 0.454% w/w stannous fluoride (1100ppm fluoride)Participants will be instructed to dose a dry toothbrush with a full strip of toothpaste containing 0.454% weight by weight (w/w) stannous fluoride (1100 parts per million [ppm] fluoride). Participants will then brush each of the two selected sensitive test teeth first, followed by the whole mouth thoroughly for at least 1 minute.
Control Dentifrice	Placebo comparator	Other: 0.76% sodium monofluorophosphate (1000ppm fluoride)Participants will be instructed to apply a full brush head of toothpaste containing 0.76% sodium monofluorophosphate (1000ppm fluoride) to a dry toothbrush. Participants will then brush the whole mouth thoroughly for at least 1 minute.

Who may qualify

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

Key inclusion criteria (8 listed)

Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form.
Participant is male or female aged between 18 and 65 years inclusive.
Good general and mental health with, in the opinion of the investigator or medically qualified designee.
No clinically significant and relevant abnormalities in medical history or upon oral examination.
Absence of any condition that would impact on the participant's safety or well being or affect the individual's ability to understand and follow study procedures and requirements.

Key exclusion criteria (21 listed)

Women who are pregnant or breast-feeding .
Daily doses of medication/treatments which, in the opinion of the Investigator, could interfere with the perception of pain. Examples of such medications include analgesics, anticonvulsants, antihistamines that cause marked or moderate sedation, sedatives, tranquilisers, anti-depressants, mood-altering and anti-inflammatory drugs.
Currently taking antibiotics or has taken antibiotics within two weeks of Baseline.
Daily dose of a medication which, in the opinion of the investigator, is causing xerostomia.
Presence of kidney disease, hyperoxaluria, or any other condition that may be exacerbated by oxalic acid or oxalate salts.

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
0.454% w/w stannous fluoride (1100ppm fluoride)Dentifrice containing 0.454% w/w stannous fluoride (1100ppm fluoride)	Other	Test Dentifrice
0.76% sodium monofluorophosphate (1000ppm fluoride)Dentifrice containing 0.76% sodium monofluorophosphate (1000ppm fluoride)	Other	Control Dentifrice

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 Day 7
Time frame: Baseline, Day 7
Change From Baseline in Tactile Threshold on Day 7 and 14
Time frame: Baseline, Day 7 and Day 14

Results and safety

Results posted to the registry on 25 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
Test Dentifrice	72	68
Control Dentifrice	70	68

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	Test Dentifrice n = 68	Control Dentifrice n = 68
Value	-1.01 (1.093)	-0.88 (1.110)

Test Dentifrice vs Control Dentifrice: Least Square (LS) Mean Difference: -0.12 (95% CI -0.497 to 0.252), p = 0.5191, ANCOVA

Population analysed: Analysis for this outcome was conducted on ITT population, defined as all participants who were randomized, received study treatment at least once \& provided at least one post-baseline (post treatment) assessment of efficacy. Number of participants analyzed is number of participants from ITT population evaluated on Day 14.

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
Test Dentifrice	0 of 72 (0%)	15 of 72 (20.8%)	0 of 72
Control Dentifrice	0 of 70 (0%)	10 of 70 (14.3%)	0 of 70

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Dentin Sensitivity

Not yet recruiting
The Effect of Decoupling With Time Technique on the Clinical Performance of Proximal Posterior Composite Restorations
Dental Restoration Failure, Postoperative Hypersensitivity
Recruiting
A Study to Assess the Efficacy of a Calcium Sodium Phosphosilicate Toothpaste for the Relief of Dentine Hypersensitivity
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Active, not recruiting
Clinical Evaluation of Short Dentin Etching
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Recruiting
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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

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

Questions about this trial

What is this clinical trial studying?

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 8 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 25 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United Kingdom. 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. Some participants in this study may receive a placebo. 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 25 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 NCT02705716.

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 25 Apr 2017.