CariesPhase 3NCT01005966

In Situ Caries Model of Fluoride Toothpastes

A Phase 3 study testing Sodium Fluoride Toothpaste, Amine Fluoride Toothpaste and Sodium monofluorophosphate/Sodium Fluoride Toothpaste in people with Caries, run by GlaxoSmithKline.

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 is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model Read more about this study

Who is it for?: Ages 18 to 80 yearsHealthy volunteers can take part
Conditions the study is for: Caries
What is being tested?: Sodium Fluoride Toothpaste, Amine Fluoride Toothpaste and Sodium monofluorophosphate/Sodium Fluoride Toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 65 participants
Where: No sites listed yet
Study dates: Nov 2008to Mar 2009
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 80 years
All sexes
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
Age:Aged 18 to 80 years inclusive
Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
Residency: Currently living in the Indianapolis, Indiana area
Dentures: a) Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accommodate two enamel specimens (required dimensions 12 x 7 millimeters (mm). b) Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. c) All restorations in a good state of repair
Salivary Flow: Have a salivary flow rate in the range of normal values (unstimulated whole saliva flow rate ≥ 0.2 mL/minute; gum base stimulated whole saliva flow rate ≥ 0.8 mL/minute).

Who cannot join

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Breast-feeding: Women who are breast-feeding
Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
Fluoride: Prescribed or professionally recommended use of fluoride supplements or fluoride mouthrinse

Show all 9Show fewer

Substance abuse: Recent history (within last year) of alcohol or other substance abuse
Dental Health: Current active caries or periodontal disease that may compromise the study or health of the subjects
Personnel: a. A member of the site study staff who is directly working on the project or living in that staff's household. b. An employee of the sponsor c. Any employee of any toothpaste manufacturer or their spouse or family member

About this study

Official title: Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model

Conditions: Caries
Being tested: Sodium Fluoride Toothpaste, Amine Fluoride Toothpaste, Sodium monofluorophosphate/Sodium Fluoride Toothpaste, Placebo, 675 ppmf toothpaste
Keywords: remineralization, enamel, in situ, fluoride, caries

What participants receive

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

Sodium Fluoride ToothpasteDrug
Test product
Amine Fluoride ToothpasteDrug
Test product
Sodium monofluorophosphate/Sodium Fluoride ToothpasteDrug
test product
PlaceboDrug
placebo and washout treatment
675 ppmf toothpasteDrug
dose response

Study groups in NCT01005966
Study group	Role	What they receive
Run in	Other	Placebo Receives: Drug: Placebo
Sodium Fluoride Toothpaste	Experimental	Sodium fluoride toothpaste Receives: Drug: Sodium Fluoride Toothpaste
Amine Fluoride Toothpaste	Active comparator	Amine Fluoride Receives: Drug: Amine Fluoride Toothpaste
675ppmf toothpaste	Other	Dose response Receives: Drug: 675 ppmf toothpaste
Sodium monofluorophosphate/sodium fluoride Toothpaste	Active comparator	Sodium monofluorophosphate/sodium fluoride Toothpaste Receives: Drug: Sodium monofluorophosphate/Sodium Fluoride Toothpaste
0 ppmf toothpaste	Placebo comparator	Not described Receives: Drug: Placebo

What is being measured

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

Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).
Measured: Baseline to 14 days

Secondary outcomes (2)

Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)
SMH test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Differences in percent SMH recovery due to study and reference toothpastes were calculated.
Measured: Baseline to 14 days
Change From Baseline in Enamel Fluoride Uptake Potential
Enamel fluoride uptake was determined using the microdrill enamel biopsy technique. The amount of fluoride uptake by enamel was calculated based on the amount of fluoride (F) divided by the area of the enamel cores. The difference between treatments was calculated with respect to fluoride uptake by enamel.
Measured: Baseline to 14 days

Timeline

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

Nov 2008Mar 2009

First posted2 Nov 2009 (estimated)
Study startNov 2008
Primary completionMar 2009
Study completionMar 2009

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 CariesStudies 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: Crossover
Masking: Single blind
Who is masked: Investigator
Enrolment: 65 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01005966
Sponsor's protocol ID: T3508605
Status last verified: Nov 2012
First submitted: 15 Oct 2009
Last updated: 29 Jul 2013
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?

Official record

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Study at a glance

From the registry record, last updated by the sponsor on 29 Jul 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Clinical Efficacy of Fluoride Toothpastes Using an in Situ Caries Model
ClinicalTrials.gov ID: NCT01005966
Acronym / sponsor ID: T3508605
Conditions: Caries
Keywords: remineralization, enamel, in situ, fluoride, caries
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 65 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2008
Primary completion: Mar 2009 (actual)
Study completion: Mar 2009 (actual)
First posted: 2 Nov 2009 (estimated)
Results: Posted 29 Jul 2013

Clinical summary

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

This study is to evaluate the effect of fluoride dentrifrices on enamel with artificial caries lesions in an in situ model

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 6

Arm	Type	Receives
Run in	Other	Drug: PlaceboPlacebo
Sodium Fluoride Toothpaste	Experimental	Drug: Sodium Fluoride ToothpasteSodium fluoride toothpaste
Amine Fluoride Toothpaste	Active comparator	Drug: Amine Fluoride ToothpasteAmine Fluoride
675ppmf toothpaste	Other	Drug: 675 ppmf toothpasteDose response
Sodium monofluorophosphate/sodium fluoride Toothpaste	Active comparator	Drug: Sodium monofluorophosphate/Sodium Fluoride ToothpasteSodium monofluorophosphate/sodium fluoride Toothpaste
0 ppmf toothpaste	Placebo comparator	Drug: Placebo

Who may qualify

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

Key inclusion criteria (7 listed)

Consent:Demonstrates understanding of the study and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
Age:Aged 18 to 80 years inclusive
Compliance: Understands and is willing, able and likely to comply with all study procedures and restrictions
General Health:Good general health with (in the opinion of the investigator) no clinically significant and/or relevant abnormalities of medical history or oral examination that could interfere with subject safety during the study period
Residency: Currently living in the Indianapolis, Indiana area

Key exclusion criteria (9 listed)

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
Breast-feeding: Women who are breast-feeding
Allergy/Intolerance:Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
Clinical Study/Experimental Medication: a. Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study GSK dental studies where the wash in period prior to treatment is sufficient. b. Previous participation in this study
Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit

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
Sodium Fluoride ToothpasteTest product	Drug	Sodium Fluoride Toothpaste
Amine Fluoride ToothpasteTest product	Drug	Amine Fluoride Toothpaste
Sodium monofluorophosphate/Sodium Fluoride Toothpastetest product	Drug	Sodium monofluorophosphate/sodium fluoride Toothpaste
Placeboplacebo and washout treatment	Drug	0 ppmf toothpaste, Run in
675 ppmf toothpastedose response	Drug	675ppmf toothpaste

Primary outcome

Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)
Time frame: Baseline to 14 days
SMH recovery test was used to assess the changes in mineralization status of enamel specimens using a Wilson 2100 Hardness tester. SMH was determined by measuring the length of the indentations of enamel specimens. An increase in the indentation length compared to the baseline indicates softening while decrease in the indentation length represents rehardening of enamel surface. Difference in percent SMH recovery was calculated by comparing study NaF toothpaste (1426ppmF) with reference AmF toothpaste (1400ppmF).

2 secondary outcomes

Percent SMH Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste (1400ppm F) and Placebo (0ppmF)
Time frame: Baseline to 14 days
Change From Baseline in Enamel Fluoride Uptake Potential
Time frame: Baseline to 14 days

Results and safety

Results posted to the registry on 29 Jul 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
Sodium Fluoride(NaF) Toothpaste[1426parts Per Million(Ppm)F]	13	11
Amine Fluoride(AmF) Toothpaste (1400ppmF)	13	13
Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)	13	12
NaF Toothpaste (675ppmF)	13	13
Placebo Toothpaste (0ppmF)	13	13

Primary outcome: Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF)

Time frame: Baseline to 14 days. Mean (Standard Error). Unit: Percentage SMHR

Measure	NaF Toothpaste (1426ppmF) n = 56	AmF Toothpaste (1400ppmF) n = 57
Value	38.05 (2.52)	41.06 (2.53)

NaF Toothpaste (1426ppmF) vs AmF Toothpaste (1400ppmF): Adjusted Mean Difference: -3.01 (95% CI -7.75 to 1.73), p = 0.2117, ANOVA

Population analysed: Per protocol (PP) population: All randomized participants who received at least one dose of the study treatments and provided at least one measurement SMH. Participants without any major protocol violations in given study treatment period were included in the PP population.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: All AEs encountered or spontaneously reported following administration of any investigational product (including washout product), or for up to 5 days after the last administration of investigational product were recorded.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NaF Toothpaste (1426ppmF)	0 of 57 (0%)	1 of 57 (1.8%)	Not reported
AmF Toothpaste (1400ppmF)	0 of 57 (0%)	5 of 57 (8.8%)	Not reported
NaMFP/ NaF Toothpaste (1450ppmF)	0 of 59 (0%)	0 of 59 (0%)	Not reported
NaF Toothpaste (675ppmF)	0 of 59 (0%)	3 of 59 (5.1%)	Not reported
Placebo Toothpaste (0ppmF)	0 of 59 (0%)	2 of 59 (3.4%)	Not reported
Overall	0 of 65 (0%)	10 of 65 (15.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2013.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sodium Fluoride Toothpaste, Amine Fluoride Toothpaste and Sodium monofluorophosphate/Sodium Fluoride Toothpaste in people with Caries, run by GlaxoSmithKline.

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 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 29 Jul 2013. Status can change between updates, so confirm with the study contact before making plans.

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.

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 29 Jul 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?

Percent Surface Microhardness (SMH) Recovery of Enamel Specimens Exposed to NaF Toothpaste (1426ppmF) and AmF Toothpaste (1400ppmF) (time frame: Baseline to 14 days). 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 NCT01005966.

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 29 Jul 2013.