Healthy SubjectsPhase 3NCT00708123

In Situ Caries of Fluoride Toothpastes

A Phase 3 study testing Sodium fluoride toothpaste in people with Healthy Subjects and Partial Denture Wearers, 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 dentifrices on enamel with artificial caries lesions in an in situ model. Read more about this study

Who is it for?: Ages 18 to 78 yearsHealthy volunteers can take part
Conditions the study is for: Healthy Subjects, Partial Denture Wearers, Caries
What is being tested?: Sodium fluoride toothpaste
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 60 participants
Where: No sites listed yet
Study dates: Nov 2007to Apr 2008
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 78 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 between 18 and 78 years.
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.
Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. 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). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.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. No pregnancy test will be required.
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:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 weeks prior to the screening visit.
Fluoride:Taking fluoride supplements for medical reasons.
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, b) An employee of the sponsor, c) Any employee of any toothpaste manufacturer or their spouse or family member.

About this study

Official title: Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model

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

Read the detailed description

Topical fluorides have been proven to be clinically effective in the prevention of dental caries. It is generally agreed that anti-caries effect of fluoride (F) is mainly by decreasing the rate of enamel demineralization and enhancing the rate of enamel remineralization. An in-situ Surface Micro-hardness (SMH) test is widely used to evaluate enamel demineralization and remineralization during the caries process. The aim of this study was to evaluate the efficacy of toothpaste formulations containing fluoride from different sources [sodium fluoride (NaF) and sodium monofluorophosphate (NaMFP)] using an in situ caries model.

Conditions: Healthy Subjects, Partial Denture Wearers, Caries
Being tested: Sodium fluoride toothpaste, Placebo toothpaste
Keywords: remineralization, enamel, fluoride, caries, in situ

What participants receive

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

Sodium fluoride toothpasteDrug
Also called Fluoride
Various fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F
Placebo toothpasteDrug
Fluoride free toothpaste (0 ppm F)

Study groups in NCT00708123
Study group	Role	What they receive
Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]	Active comparator	Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Receives: Drug: Sodium fluoride toothpaste
NaF/Carbopol toothpaste (1400 ppm F)	Experimental	Participants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Receives: Drug: Sodium fluoride toothpaste
NaMFP/NaF toothpaste (1450 ppm F)	Active comparator	Participants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Receives: Drug: Sodium fluoride toothpaste
NaF toothpaste (250 ppm F)	Active comparator	Participants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth. Receives: Drug: Sodium fluoride toothpaste
Placebo toothpaste (0 ppm F)	Placebo comparator	Participants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth. Receives: Drug: Placebo toothpaste

What is being measured

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

Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Measured: Baseline to 14 days

Secondary outcomes (2)

Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.
Measured: Baseline to 14 days
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
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 and expressed as ug F/cm2. 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 2007Apr 2008

First posted2 Jul 2008 (estimated)
Study startNov 2007
Primary completionApr 2008
Study completionApr 2008

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 Healthy SubjectsStudies 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: Double blind
Who is masked: Participant, Investigator
Enrolment: 60 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708123
Sponsor's protocol ID: T3157503
Status last verified: Mar 2013
First submitted: 1 Jul 2008
Last updated: 22 Apr 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 22 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of the Clinical Efficacy From the Retention Phase of Fluoride Delivery of Fluoride Toothpastes Using an in Situ Caries Model
ClinicalTrials.gov ID: NCT00708123
Acronym / sponsor ID: T3157503
Conditions: Healthy Subjects, Partial Denture Wearers, Caries
Keywords: remineralization, enamel, fluoride, caries, in situ
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 60 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Nov 2007
Primary completion: Apr 2008 (actual)
Study completion: Apr 2008 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Posted 19 Nov 2012

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 dentifrices on enamel with artificial caries lesions in an in situ model.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (participant, investigator)
Number of arms: 5

Arm	Type	Receives
Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]	Active comparator	Drug: Sodium fluoride toothpasteParticipants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (1350 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
NaF/Carbopol toothpaste (1400 ppm F)	Experimental	Drug: Sodium fluoride toothpasteParticipants to brush their natural teeth twice daily with a full ribbon of NaF and 0.5% carbopol toothpaste (1450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
NaMFP/NaF toothpaste (1450 ppm F)	Active comparator	Drug: Sodium fluoride toothpasteParticipants to brush their natural teeth twice daily with a full ribbon of NaMFPand NaF toothpaste (1450 ppm F - 1000 ppm F as NaMFP and 450 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
NaF toothpaste (250 ppm F)	Active comparator	Drug: Sodium fluoride toothpasteParticipants to brush their natural teeth twice daily with a full ribbon of NaF toothpaste (250 ppm F as NaF) for one timed minute, after removing their partial denture from their mouth.
Placebo toothpaste (0 ppm F)	Placebo comparator	Drug: Placebo toothpasteParticipants to brush their natural teeth twice daily with a full ribbon of fluoride free toothpaste (0 ppm F) for one timed minute, after removing their partial denture from their mouth.

Who may qualify

Ages: 18 to 78 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 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 between 18 and 78 years.
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.
Diagnosis: Oral - i. Currently living in the Indianapolis area which is a fluoridated community (1 ppm F). ii. 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). iii. Willing and capable of wearing their removable partial dentures 24 hours per day during each two week treatment period. iv.All restorations in a good state of repair.

Key exclusion criteria (8 listed)

Pregnancy:Women who are known to be pregnant or who are intending to become pregnant over the duration of the study. No pregnancy test will be required.
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:Participation in another clinical study or receipt of an investigational drug within 30 days of the first treatment visit, with the exception of study T3157495 where the wash in period prior to treatment is sufficient.
Antibiotics:Currently taking antibiotics or have taken antibiotics in the 2 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 toothpasteAlso: FluorideVarious fluoride toothpastes containing 1350 ppm F, 1450 ppm F, 1400 ppm F and 250 ppm F	Drug	NaF toothpaste (250 ppm F), NaF/Carbopol toothpaste (1400 ppm F), NaMFP/NaF toothpaste (1450 ppm F), Sodium Fluoride (NaF) toothpaste[1350 parts per million(ppm)F]
Placebo toothpasteFluoride free toothpaste (0 ppm F)	Drug	Placebo toothpaste (0 ppm F)

Primary outcome

Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)
Time frame: Baseline to 14 days
%SMHR test was used to assess mineralization status of enamel specimens using a Wilson 2100 Hardness tester. %SMHR 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. %SMHR was calculated from indentation values of enamel specimens at baseline (B), after intra-oral exposure (R) and after in-vitro demineralization (D) using formula: [(D-R)/ (D-B)]*100.

2 secondary outcomes

Mean %SMHR of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (250ppmF) and Placebo Toothpaste (0ppmF)
Time frame: Baseline to 14 days
Adjusted Mean Change From Baseline in Enamel Fluoride Uptake
Time frame: Baseline to 14 days

Results and safety

Results posted to the registry on 19 Nov 2012, 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[1350 Parts Per Million(Ppm)F]	12	12
NaF/Carbopol Toothpaste (1400 Ppm F)	12	11
NaMFP/NaF Toothpaste (1450 Ppm F)	12	11
NaF Toothpaste (250 Ppm F)	12	11
Placebo Toothpaste (0 Ppm F)	12	12

Primary outcome: Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF)

Time frame: Baseline to 14 days. Least squares mean (Standard Error). Unit: %SMHR

Measure	NaF/Carbopol Toothpaste (1400 Ppm F) n = 54	NaF Toothpaste (1350 Ppm F) n = 53	NaMFP/NaF Toothpaste (1450 Ppm F) n = 54
Value	33.54 (1.72)	35.23 (1.74)	29.57 (1.72)

NaF/Carbopol Toothpaste (1400 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F): Adjusted mean difference: 3.97 (95% CI 0.47 to 7.48), p = 0.0265, ANOVA
NaF Toothpaste (1350 Ppm F) vs NaMFP/NaF Toothpaste (1450 Ppm F): Adjusted mean difference: 5.66 (95% CI 2.15 to 9.18), p = 0.0017, ANOVA

Population analysed: Intent to treat population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to subject drop outs, there are differences in the "n" per treatment group.

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/ Carbopol Toothpaste (1400 Ppm F)	0 of 56 (0%)	4 of 56 (7.1%)	Not reported
NaF Toothpaste (1350ppm F)	0 of 54 (0%)	4 of 54 (7.4%)	Not reported
NaMFP/NaF Toothpaste (1450 Ppm F)	0 of 55 (0%)	1 of 55 (1.8%)	Not reported
NaF Toothpaste (250 Ppm F)	0 of 56 (0%)	1 of 56 (1.8%)	Not reported
Placebo Toothpaste (0 Ppm F)	0 of 54 (0%)	2 of 54 (3.7%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 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 in people with Healthy Subjects and Partial Denture Wearers, 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 6 inclusion and 8 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 22 Apr 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 19 Nov 2012). 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?

Mean Percentage Surface Microhardness Recovery (%SMHR) of Enamel Specimens Exposed to NaF/Carbopol Toothpaste (1400 ppmF), NaF Toothpaste (1350ppmF) Compared to NaMFP/NaF Toothpaste (1450ppmF) (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 NCT00708123.

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 22 Apr 2013.