Dentin SensitivityNCT02768194

Dentine Tubule Occlusion Assessment in a Modified in Situ Model

A study testing Stannous fluoride, Sodium monofluorophosphate and Mineral water in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site 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 will be a single centre, single blind, randomized, three treatment, three period crossover design, modified, in situ, study in healthy participants. In this in situ model the tubule occlusion properties of dentifrices will be evaluated by comparing an experimental dentifrice formulation to a regular fluoride… Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Dentin Sensitivity
What is being tested?: Stannous fluoride, Sodium monofluorophosphate and Mineral water
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 26 participants
Where: 1 siteUnited Kingdom
Study dates: 6 Jul 2016to 21 Sep 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 80 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.
Aged between 18 and 80 years
Understands and is willing, able and likely to comply with all study procedures and restrictions.
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 procedures and requirements.
Be able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples

Who cannot join

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Women who are breast-feeding
Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes.
Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Participation in another study (clinical or cosmetic studies) or receipt of an investigational drug within 15 days of the screening visit, previous participation in this study.

Show all 9Show fewer

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. The site for this protocol is the Clinical Trials Unit in the Bristol Dental School and Hospital. Employees of the Bristol Dental School and Hospital not associated with the Clinical Trials Unit are eligible to participate
Any participant who, in the judgement of the investigator, should not participate in the study

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Bristol, BS1 2LY

Other trials in United Kingdom

About this study

Official title: Assessment of Dentine Tubule Occlusion in a Modified in Situ Model

Read the detailed description

This modified in situ model study will evaluate the mode-of-action of an experimental dentifrice containing stannous fluoride to occlude tubules compared to a regular fluoride dentifrice and a negative control (mineral water). The study treatments will be administered for a total of 10 days, with participants wearing two appliances in their mouth that will hold samples of dentine. The dentine samples will be examined after 1, 4, 8 and 10 days of treatment using scanning electron microscopy (SEM) and the resulting images graded for the amount of occlusion. In addition, the robustness of any occlusion generated by the treatments will be tested by exposing the dentine samples to an acid challenge (orange juice) after 9 and 10 days treatment.

Conditions: Dentin Sensitivity
Being tested: Stannous fluoride, Sodium monofluorophosphate, Mineral water
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 fluorideDevice
Dentifrice containing 0.454% stannous fluoride
Sodium monofluorophosphateOther
Dentifrice containing 0.76% sodium monofluorophosphate
Mineral waterOther
Commercially available mineral water

Study groups in NCT02768194
Study group	Role	What they receive
Test Product (0.454% stannous fluoride)	Experimental	Participants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. Receives: Device: Stannous fluoride
Reference Product (0.76% sodium monofluorophosphate)	Active comparator	Participants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. Receives: Other: Sodium monofluorophosphate
Negative Control (Mineral water)	Other	Participants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds. Receives: Other: Mineral water

What is being measured

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

Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Measured: Baseline and Day 8

Secondary outcomes (1)

Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded
Measured: Baseline, Day 1, 4, and 10

Timeline

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

6 Jul 201621 Sep 2016

First posted11 May 2016 (estimated)
Study start6 Jul 2016
Primary completion1 Sep 2016
Study completion21 Sep 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.
Publications (1)Papers the sponsor has linked to this study.
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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind
Who is masked: Outcomes assessor
Enrolment: 26 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02768194
Sponsor's protocol ID: 205699
Status last verified: Mar 2018
First submitted: 9 May 2016
Last updated: 25 Jun 2018
Results posted: Yes, on ClinicalTrials.gov

Publications

West NX, Seong J, Hellin N, Macdonald EL, Jones SB, Creeth JE. Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: A randomised clinical in situ study. J Dent. 2018 Sep;76:125-131. doi: 10.1016/j.jdent.2018.07.001. Epub 2018 Jul 5.
PubMed 29981778

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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All Dentin Sensitivity trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Dentine Tubule Occlusion in a Modified in Situ Model
ClinicalTrials.gov ID: NCT02768194
Acronym / sponsor ID: 205699
Conditions: Dentin Sensitivity
Study type: Interventional
Recruitment status: Completed
Enrolment: 26 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 6 Jul 2016 (actual)
Primary completion: 1 Sep 2016 (actual)
Study completion: 21 Sep 2016 (actual)
First posted: 11 May 2016 (estimated)
Results: Posted 13 Mar 2018

Clinical summary

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

Detailed description

Study design

Primary purpose: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (outcomes assessor)
Number of arms: 3

Arm	Type	Receives
Test Product (0.454% stannous fluoride)	Experimental	Device: Stannous fluorideParticipants will use dentifrice containing 0.454% stannous fluoride. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Reference Product (0.76% sodium monofluorophosphate)	Active comparator	Other: Sodium monofluorophosphateParticipants will use dentifrice containing 0.76% sodium monofluorophosphate. Appliances brushed ex situ in 1:3 slurry of freshly prepared dentifrice twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in a 1:3 slurry of assigned dentifrice. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.
Negative Control (Mineral water)	Other	Other: Mineral waterParticipants will use commercially available mineral water. Appliances brushed ex situ in mineral water twice daily will be then returned to the participant's mouth. Each appliance will be brushed for 1 minute (2 minutes total for both of the participant's appliances) using an electric toothbrush in mineral water. Appliances will be returned to the participant's mouth and the participant will rinse with 10 mls of mineral water for 5 seconds.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (5 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.
Aged between 18 and 80 years
Understands and is willing, able and likely to comply with all study procedures and restrictions.
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 procedures and requirements.
Be able to accommodate the lower bi-lateral buccal intra-oral appliances each fitted with four dentine samples

Key exclusion criteria (9 listed)

Women who are known to be pregnant or who are intending to become pregnant over the duration of the study.
Women who are breast-feeding
Current or recurrent disease/dental pathology that in the opinion of the investigator could affect the study outcomes.
Current susceptibility to acid regurgitation, any orthodontic appliances, restorations, bridgework or dentures that in the opinion of the investigator would interfere with the study outcomes, recurrent or regular aphthous ulcers, severe gingivitis, carious lesions and periodontal disease,signs of severe dental erosion, any condition or medication which in the opinion of the investigator is currently causing xerostomia, and individuals who require antibiotic prophylaxis for dental procedures
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients

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 0.454% stannous fluoride	Device	Test Product (0.454% stannous fluoride)
Sodium monofluorophosphateDentifrice containing 0.76% sodium monofluorophosphate	Other	Reference Product (0.76% sodium monofluorophosphate)
Mineral waterCommercially available mineral water	Other	Negative Control (Mineral water)

Primary outcome

Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application
Time frame: Baseline and Day 8
Change from baseline (pre-dose) in the mean occlusion classification score was calculated. The degree of occlusion was measured using the following classification grades; 0 Not Evaluable, 1 Occluded, 2 Mostly Occluded, 3 Equally Occluded/Unoccluded, 4 Mostly Unoccluded and 5 Unoccluded

1 secondary outcome

Change From Baseline in Mean Occlusion Scores After 1, 4, & 10 Days Treatment Application
Time frame: Baseline, Day 1, 4, and 10

Results and safety

Results posted to the registry on 13 Mar 2018, 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 /Negative Control/Reference	4	4
Test/Reference/Negative Control	4	4
Negative Control/Test/Reference	4	4
Negative Control/Reference/Test	4	3
Reference/Test/Negative Control	4	4
Reference/Negative Control/Test	4	4

Primary outcome: Change From Baseline in Mean Occlusion Scores After 8 Days Treatment Application

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

Measure	Test Product n = 23	Reference Product n = 22	Negative Control n = 24
Pre-dose (Baseline)	4.38 (0.383)	4.32 (0.518)	4.36 (0.398)
Post-dose (Post Baseline)	3.43 (0.760)	3.42 (0.754)	3.53 (0.865)
Change	-0.95 (0.925)	-0.90 (0.933)	-0.83 (0.849)

Test Product vs Negative Control: Mean Difference (Net): -0.11 (95% CI -0.46 to 0.25), p = 0.5512, Mixed Models Analysis
Test Product vs Reference Product: Mean Difference (Net): -0.01 (95% CI -0.36 to 0.35), p = 0.9671, Mixed Models Analysis
Reference Product vs Negative Control: Mean Difference (Net): -0.10 (95% CI -0.46 to 0.26), p = 0.5830, Mixed Models Analysis

Population analysed: Per protocol (PP) Population was the primary analysis population, defined as those participants in the ITT (Intent to treat) population for whom all post baseline scanning electron microscopy (SEM) image scores were not deemed to be affected by protocol violations.

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Baseline to Day 10. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Product	0 of 23 (0%)	2 of 23 (8.7%)	0 of 23
Reference Product	0 of 22 (0%)	4 of 22 (18.2%)	0 of 22
Negative Control	0 of 24 (0%)	3 of 24 (12.5%)	0 of 24

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 29981778West NX, Seong J, Hellin N, Macdonald EL, Jones SB, Creeth JE. Assessment of tubule occlusion properties of an experimental stannous fluoride toothpaste: A randomised clinical in situ study. J Dent. 2018 Sep;76:125-131. doi: 10.1016/j.jdent.2018.07.001. Epub 2018 Jul 5.

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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 study testing Stannous fluoride, Sodium monofluorophosphate and Mineral water in people with Dentin Sensitivity, run by GlaxoSmithKline at 1 site in United Kingdom.

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 9 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 Jun 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 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. 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 13 Mar 2018). 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 Mean Occlusion Scores After 8 Days Treatment Application (time frame: Baseline and Day 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 NCT02768194, 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 25 Jun 2018; AzTrials last refreshed its copy on 7 Nov 2026.