CariesPhase 3NCT00708097

In Situ Caries Efficacy of Fluoride Toothpastes

A Phase 3 study testing NaF and NaMFP in people with Caries, run by GlaxoSmithKline at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

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: Caries
What is being tested?: NaF and NaMFP
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 57 participants
Where: 1 siteUnited States
Study dates: Apr 2008to Jul 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 80 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 relevant abnormalities of medical history or physical examination.
Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons
Dentures: a)Currently wearing a removable mandibular partial denture with sufficient room in both posterior buccal flange areas to accommodate two enamel specimens on each side, four specimens in total - required dimensions 12 x 7 millimeter (mm) per side. b) Willing to have their denture modified to accommodate enamel test specimens and willing and capable of wearing their removable mandibular partial dentures 24 hours per day during the experimental periods
Dental health: Have no current active caries or periodontal disease that may compromise the study or the health of the subjects and 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 milliliter (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.
Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.
Substance abuse: Recent history (within the last year) of alcohol or other substance abuse.
Personnel:a) A member of the site study staff living in same household.b)An employee of the sponsor. c) Any employee of any toothpaste manufacturer or their spouse or family member

Trial locations and contacts

1 site in 1 country.

United States1 site

Indiana University School of Dentistry
Indianapolis, Indiana, 46202

Other trials in United States

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

Read the detailed description

In situ models represent an acceptable approach for testing the anti-caries potential of fluoride products. This study is to evaluate the effect of fluoride dentifrice containing 1450 parts per million fluoride (ppm F) on enamel with artificial caries lesions in an in situ model. The study toothpaste containing sodium fluoride (NaF) and 0.4% carbopol will be compared to 4 other dentifrices. Comparator toothpastes include NaF toothpaste (1400 ppm F), NaF toothpaste (675 ppm F), sodium monofluorophosphate (NaMFP) and NaF toothpaste (1450 ppm F) and placebo toothpaste (0 ppm F).

Conditions: Caries
Being tested: NaF, Placebo, NaMFP
Keywords: fluoride, in situ, remineralization, enamel, caries

What participants receive

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

NaFDrug
Also called Fluoride
Fluoride
PlaceboDrug
Placebo
NaMFPDrug
Fluoride

Study groups in NCT00708097
Study group	Role	What they receive
NaF toothpaste(1450 ppmF)	Experimental	Study toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient. Receives: Drug: NaF
NaF toothpaste (1400 ppmF)	Active comparator	Study toothpaste containing 1400 ppm F as NaF Receives: Drug: NaF
NaMFP/NaF toothpaste (1450 ppmF)	Active comparator	Reference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF Receives: Drug: NaF; Drug: NaMFP
NaF toothpaste (675 ppmF)	Active comparator	Study toothpaste containing 675 ppm F as NaF Receives: Drug: NaF
Placebo toothpaste (0 ppmF)	Placebo comparator	Fluoride free placebo toothpaste (0 ppm F) Receives: Drug: Placebo

What is being measured

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

Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.
Measured: Baseline to 14 days

Secondary outcomes (4)

Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.
Measured: Baseline to 14 days
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.
Measured: Baseline to 14 days
Enamel Fluoride Uptake (Sound Enamel Specimens)
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
Enamel Fluoride Uptake (Demineralized Specimens)
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.

Apr 2008Jul 2008

First posted2 Jul 2008 (estimated)
Study startApr 2008
Primary completionJul 2008
Study completionJul 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 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: 57 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00708097
Sponsor's protocol ID: T3508565
Status last verified: Dec 2014
First submitted: 1 Jul 2008
Last updated: 1 Jan 2015
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

Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries

All Caries trials

Study at a glance

From the registry record, last updated by the sponsor on 1 Jan 2015. 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: NCT00708097
Acronym / sponsor ID: T3508565
Conditions: Caries
Keywords: fluoride, in situ, remineralization, enamel, caries
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 57 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Apr 2008
Primary completion: Jul 2008 (actual)
Study completion: Jul 2008 (actual)
First posted: 2 Jul 2008 (estimated)
Results: Posted 24 Jun 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 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: Single blind (investigator)
Number of arms: 5

Arm	Type	Receives
NaF toothpaste(1450 ppmF)	Experimental	Drug: NaFStudy toothpaste containing 1450 ppm F as NaF and 0.4% carbopol as excipient.
NaF toothpaste (1400 ppmF)	Active comparator	Drug: NaFStudy toothpaste containing 1400 ppm F as NaF
NaMFP/NaF toothpaste (1450 ppmF)	Active comparator	Drug: NaF, Drug: NaMFPReference toothpaste containing 1000 ppm F as NaMFP and 450 ppm F as NaF
NaF toothpaste (675 ppmF)	Active comparator	Drug: NaFStudy toothpaste containing 675 ppm F as NaF
Placebo toothpaste (0 ppmF)	Placebo comparator	Drug: PlaceboFluoride free placebo toothpaste (0 ppm F)

Who may qualify

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

Key inclusion criteria (8 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 80 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 relevant abnormalities of medical history or physical examination.
Fluoride:Currently living in the Indianapolis, Indiana area and not taking fluoride supplements for medical reasons

Key exclusion criteria (7 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.
Antibiotics: Currently taking antibiotics or have taken antibiotics in the two weeks prior to the screening visit
Clinical Study/Experimental Medication: a) Participation in another clinical study or receipt of an investigational drug within 30 days of the screening visit.b) Participation in another GSKCH investigational dental product study within 7 days of first study treatment c)Previous participation in this study.

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
NaFAlso: FluorideFluoride	Drug	NaF toothpaste (1400 ppmF), NaF toothpaste (675 ppmF), NaF toothpaste(1450 ppmF), NaMFP/NaF toothpaste (1450 ppmF)
PlaceboPlacebo	Drug	Placebo toothpaste (0 ppmF)
NaMFPFluoride	Drug	NaMFP/NaF toothpaste (1450 ppmF)

Primary outcome

Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)
Time frame: Baseline to 14 days
SMH test was used to assess mineral status of partially demineralized enamel specimens using 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/demineralization while decrease in the indentation represents rehardening/ remineralization of enamel surface. Percent SMHR was calculated from indentation values of enamel specimens at baseline(B); after intra-oral exposure(R) on Day 14; and after in-vitro demineralization(D) on Day 14 using formula [(D-R)/(D-B)]*100.

4 secondary outcomes

Percentage SMHR of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaMFP/NaF Toothpaste (1450ppmF), NaF Toothpaste (675ppmF) and Placebo Toothpaste (0ppmF)
Time frame: Baseline to 14 days
Percentage SMHR of Demineralized Enamel Specimens Exposed to NaF Toothpaste (1450ppmF), NaF Toothpaste (1400ppmF), NaF Toothpaste (675ppmF), NaMFP/NaF Toothpaste(1450ppmF) and Placebo Toothpaste (0ppmF)
Time frame: Baseline to 14 days
Enamel Fluoride Uptake (Sound Enamel Specimens)
Time frame: Baseline to 14 days
Enamel Fluoride Uptake (Demineralized Specimens)
Time frame: Baseline to 14 days

Results and safety

Results posted to the registry on 24 Jun 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(1450 Parts Per Million(Ppm)F)	11	11
NaF Toothpaste (1400ppmF)	12	11
Sodium Monofluorophosphate (NaMFP)/NaF Toothpaste (1450ppmF)	12	12
NaF Toothpaste (675ppmF)	11	9
Placebo Toothpaste (0ppmF)	11	10

Primary outcome: Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF Toothpaste (1400ppmF)

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

Measure	NaF Toothpaste (1450ppmF) n = 50	NaF Toothpaste (1400ppmF) n = 52
Value	28.31 (5.54)	26.32 (5.51)

NaF Toothpaste (1450ppmF) vs NaF Toothpaste (1400ppmF): Adjusted Mean Difference: 1.98 (95% CI -5.00 to 8.97), p = 0.5757, ANOVA

Population analysed: Intent to Treat (ITT) population: All randomized participants who had at least one post baseline efficacy assessment. Missing data was not imputed. Due to drop outs there were differences in the number of participants (N) per treatment group.

4 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(1450ppmF)	0 of 50 (0%)	3 of 50 (6%)	Not reported
NaF Toothpaste (1400ppmF)	0 of 52 (0%)	1 of 52 (1.9%)	Not reported
NaMFP/NaF Toothpaste (1450ppmF)	0 of 53 (0%)	3 of 53 (5.7%)	Not reported
NaF Toothpaste (675ppmF)	0 of 53 (0%)	4 of 53 (7.5%)	Not reported
Placebo Toothpaste (0ppmF)	0 of 51 (0%)	1 of 51 (2%)	Not reported
Overall	0 of 57 (0%)	10 of 57 (17.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Jan 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Caries

Active, not recruiting
Trial With Two New Tooth-colored Restorative Materials in Class I/II Cavities
Caries, Defective Restorations
Active, not recruiting
Clinical Evaluation of a New Dual-cure Universal Adhesive
Class I Dental Restorations, Class II Dental Restorations
Not yet recruiting
Safety of Intraosseous Anaesthesia in Children With Haemophilia
Haemophilia A, Haemophilia B
Not yet recruitingObservational study
Diagnostic Performance of Ai vs Junior Dentists
Diagnosis
Not yet recruiting
Clinical and Radiographic Evaluation of Silver Diamine Fluoride Versus Light-Cured Silver Diamine Fluoride in Carious Primary Molars
Dental Caries

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 Phase 3 study testing NaF and NaMFP in people with Caries, run by GlaxoSmithKline at 1 site in United States.

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 7 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 1 Jan 2015. 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 States. 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.

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 24 Jun 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?

Percentage Surface Microhardness Recovery (%SMHR) of Sound Enamel Specimens Exposed to NaF Toothpaste (1450ppmF) and NaF 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 NCT00708097.

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 1 Jan 2015.