Tooth ErosionNCT02548156

Intra Oral Kinetics of Fluoride Containing Dentifrices

A study testing Test Dentifrice, Reference Dentifrice and Comparator Dentifrice in people with Tooth Erosion, 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

The aim of this study is to assess the impact of formulation differences on fluoride retention clearance with US levels of fluoride (1150 ppm of fluoride) by evaluating and comparing between treatments the concentrations of fluoride and calcium ions in saliva over 60 minutes after a single brushing with US marketed… Read more about this study

Who is it for?: Ages 18 to 65 yearsHealthy volunteers can take part
Conditions the study is for: Tooth Erosion
What is being tested?: Test Dentifrice, Reference Dentifrice and Comparator Dentifrice
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 29 participants
Where: 1 siteUnited Kingdom
Study dates: Sep 2015to Oct 2015
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
Aged 18-65 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 of medical history or 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
A minimum of 20 permanent natural teeth
A gum-base stimulated whole saliva flow rate ≥ 0.8 mL/min and an unstimulated whole saliva flow rate ≥ 0.5 mL/min.

Who cannot join

Pregnant or breast feeding women
Presence of chronic debilitating disease.
Any condition that causes xerostomia as determined by the Investigator.
Evidence of untreated caries.
Gross periodontal disease.
Tongue or lip piercing or presence of dental implants. Professional tooth cleaning or dental treatment during study. Oral surgery or extraction within 6 weeks of the screening visit.

Show all 13Show fewer

Self reported oral symptoms including lesions, sores or inflammation
Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Currently taking antibiotics or have taken antibiotics within 2 weeks of the screening visit
Any medication that could affect salivary flow or cause xerostomia as determined by the Investigator
Use of multivitamins, calcium supplements and or fluoride supplements within 7 days of treatment phase
Participant unwilling to abstain from smoking for at least 4 hours on the day of each test visit
Recent history (within the last year) of alcohol or other substance abuse.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site

GSK Investigational Site
Ellesmere Port, Cheshire, CH65 4BW

Other trials in United Kingdom

About this study

Official title: Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study

Conditions: Tooth Erosion
Being tested: Test Dentifrice, Reference Dentifrice, Comparator Dentifrice, Orange Juice, De-ionised water
Medical subject headings: Tooth Erosion

What participants receive

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

Test DentifriceOther
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Reference DentifriceOther
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Comparator DentifriceOther
Marketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3
Orange JuiceOther
Teeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.
De-ionised waterOther
Teeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.

Study groups in NCT02548156
Study group	Role	What they receive
Test dentifrice	Other	1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse Receives: Other: Test Dentifrice; Other: Orange Juice; Other: De-ionised water
Reference dentifrice	Other	1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse Receives: Other: Reference Dentifrice; Other: De-ionised water
Comparator dentifrice	Other	1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse Receives: Other: Comparator Dentifrice; Other: Orange Juice; Other: De-ionised water

What is being measured

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

Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.
Measured: 60 minutes

Secondary outcomes (3)

Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva at baseline, 1, 5, 10, 15, 30 and 60 minutes (for calcium only) after a single brushing with a fluoride dentifrice
Measured: up to 60 minutes
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in saliva following a rinse with either de ionised water or OJ 60 minutes after a single brushing with a fluoride dentifrice
Measured: 60 minutes
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Concentration of fluoride and calcium ions in the initial expectorate, de-ionized water rinse post brushing expectorate, and 60 minutes post brushing following administration of orange juice or de-ionised water rinse
Measured: up to 60 minutes

Timeline

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

Sep 2015Oct 2015

First posted14 Sep 2015 (estimated)
Study startSep 2015
Primary completionOct 2015
Study completionOct 2015

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 Tooth ErosionStudies 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: None (open label)
Enrolment: 29 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02548156
Sponsor's protocol ID: 204777
Status last verified: Jan 2017
First submitted: 10 Sep 2015
Last updated: 18 Jan 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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Salivary Function and Dental Changes During GLP-1 Therapy
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RecruitingObservational study
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
Dentin Hypersensitivity, Erosive Tooth Wear
Active, not recruiting
A Study of Tooth Erosion in People With Esophagogastric Cancer
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All Tooth Erosion trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Intra-oral Kinetics of Fluoride Containing Dentifrices in a Modified Saliva Clearance Study
ClinicalTrials.gov ID: NCT02548156
Acronym / sponsor ID: 204777
Conditions: Tooth Erosion
Study type: Interventional
Recruitment status: Completed
Enrolment: 29 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Sep 2015
Primary completion: Oct 2015 (actual)
Study completion: Oct 2015 (actual)
First posted: 14 Sep 2015 (estimated)
Results: Posted 27 Jul 2016

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: Basic science
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 3

Arm	Type	Receives
Test dentifrice	Other	Other: Test Dentifrice, Other: Orange Juice, Other: De-ionised water1.5g (± 0.05g) of Test dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse
Reference dentifrice	Other	Other: Reference Dentifrice, Other: De-ionised water1.5g (± 0.05g) of Reference dentifrice followed by 10mL of de-ionised water rinse, then 10 mL water rinse
Comparator dentifrice	Other	Other: Comparator Dentifrice, Other: Orange Juice, Other: De-ionised water1.5g (± 0.05g) of Comparator dentifrice followed by 10mL of de-ionised water rinse, then 10 mL orange juice rinse

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
Aged 18-65 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:
A minimum of 20 permanent natural teeth

Key exclusion criteria (13 listed)

Pregnant or breast feeding women
Presence of chronic debilitating disease.
Any condition that causes xerostomia as determined by the Investigator.
Evidence of untreated caries.
Gross periodontal disease.

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 DentifriceMarketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3	Other	Test dentifrice
Reference DentifriceMarketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3	Other	Reference dentifrice
Comparator DentifriceMarketed dentifrice containing 1150ppm fluoride and 5% w/w KNO3	Other	Comparator dentifrice
Orange JuiceTeeth will be rinsed with orange juice followed by rinsing with de-ionised water in test dentifrice and comparator dentifrice arms.	Other	Comparator dentifrice, Test dentifrice
De-ionised waterTeeth will be rinsed with de-ionised water followed by reference dentifrice and followed by rinsing with orange juice in test dentifrice and comparator dentifrice arms.	Other	Comparator dentifrice, Reference dentifrice, Test dentifrice

Primary outcome

Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse
Time frame: 60 minutes
Concentration of fluoride ions in saliva at 60 minutes after a single brushing with a fluoride dentifrice prior to rinsing with either de-ionised (DI) water or orange juice (OJ). Descriptive data is presented as least square (LS) mean and standard error (SE). SE for Fluoride is the SE of the raw mean.

3 secondary outcomes

Concentrations of Fluoride and Calcium Ions in Saliva Post Brushing Prior to Administration of Orange Juice or De-ionised Water Rinse
Time frame: up to 60 minutes
Concentrations of Fluoride and Calcium Ions in Saliva Following Administration of the Orange Juice or De-ionised Water Rinse
Time frame: 60 minutes
Concentrations of Fluoride and Calcium Ions in the Initial Expectorate, De-ionised Water Rinse Post Brushing Expectorate, and 60 Minutes Post Brushing Following Administration of Orange Juice or De-ionised Water Rinse
Time frame: up to 60 minutes

Results and safety

Results posted to the registry on 27 Jul 2016, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Sequence 1: Test/Comparator/Reference: Dentifrice	5	5
Sequence 2: Test/Reference/Comparator: Dentifrice	5	5
Sequence 3: Comparator/Test/Reference: Dentifrice	4	4
Sequence 4: Comparator/Reference/Test: Dentifrice	5	5
Sequence 5: Reference/Test/Comparator: Dentifrice	5	5
Sequence 6: Reference/Comparator/Test: Dentifrice	5	5

Primary outcome: Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse

Time frame: 60 minutes. Least squares mean (Standard Error). Unit: parts per million(ppm)

Measure	Test Dentifrice n = 28	Reference Dentifrice n = 28	Comparator Dentifrice n = 28
Value	0.23 (0.0469)	0.23 (0.0430)	0.15 (0.0485)

Test Dentifrice vs Reference Dentifrice vs Comparator Dentifrice: Ratio of LS mean: 1.52, p <0.0001, ANCOVA

Population analysed: The Per Protocol (PP) population was a subset of the ITT population (All randomized participants who had received study treatment and have at least one post-baseline efficacy measurement). n= number of participants analyzed for this outcome.

3 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Test Dentifrice	0 of 28 (0%)	8 of 28 (28.6%)	Not reported
Reference Dentifrice	0 of 29 (0%)	3 of 29 (10.3%)	Not reported
Comparator Dentifrice	0 of 28 (0%)	5 of 28 (17.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Tooth Erosion

Active, not recruitingPhase 3
New In Situ Model Design for Caries and Erosion
Caries, Erosive Tooth Wear
Not yet recruitingObservational study
Salivary Function and Dental Changes During GLP-1 Therapy
Obesity, Dental Erosion
Not yet recruitingObservational study
Obesity and Oral Diseases in Adult Patients
Obesity, Oral Diseases
RecruitingObservational study
Multi-site Study to Look at Tooth Wear and Tooth Sensitivity and the Risk Factors Associated.
Dentin Hypersensitivity, Erosive Tooth Wear
Active, not recruiting
A Study of Tooth Erosion in People With Esophagogastric Cancer
Esophagogastric Cancer

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 Dentifrice, Reference Dentifrice and Comparator Dentifrice in people with Tooth Erosion, 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 8 inclusion and 13 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 18 Jan 2017. 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 27 Jul 2016). 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?

Concentrations of Fluoride Ions in Saliva 60 Minutes Post Brushing Prior to Administration of the Orange Juice or De-ionised Water Rinse (time frame: 60 minutes). 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 NCT02548156.

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 18 Jan 2017.