A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model

A Phase 3 study testing Fluoride in people with Dental 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

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes. Read more about this study

Who is it for?: Ages 11 to 14 yearsHealthy volunteers can take part
Conditions the study is for: Dental Caries
What is being tested?: Fluoride
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 55 participants
Where: 1 siteUnited States
Study dates: Feb 2012to May 2012
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 11 to 14 years
All sexes
Healthy volunteers accepted
Child

Who may be able to join

Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Who cannot join

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

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Conditions: Dental Caries
Being tested: Fluoride, Placebo
Medical subject headings: Dental Caries

What participants receive

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

FluorideDrug
Fluoride Toothpaste
PlaceboDrug
Fluoride free toothpaste

Study groups in NCT01607411
Study group	Role	What they receive
Fluoride free toothpaste	Placebo comparator	toothpaste with no fluoride Receives: Drug: Placebo
1426ppm Fluoride Toothpaste	Experimental	Experimental toothpaste containing 1426 ppm Fluoride Receives: Drug: Fluoride
1000 ppm Fluoride Toothpaste	Experimental	Experimental toothpaste containing 1000 ppm Fluoride Receives: Drug: Fluoride
500 ppm Toothpaste	Experimental	Experimental toothpaste containing 500 ppm Fluoride Receives: Drug: Fluoride

What is being measured

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

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.
Measured: Baseline to 4 hours

Secondary outcomes (3)

%SMHR of Enamel Specimens Exposed to Test Treatments
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.
Measured: Baseline to 4 hours
Percent Net Acid Resistance (%NAR) of Enamel Specimens
Changes in mineral content of enamel specimens exposed to dietary erosive challenge were determined by measuring the length of the indentations. Decrease in the indentation length compared to the baseline indicates hardening of enamel surface. Enamel specimens were exposed to second erosion challenge to determine NAR which compared the indentations values of sound enamel specimens at baseline (B), first demineralization challenge (D1) and second demineralization challenge (D2). Percent NAR was calculated by formula: [(D1-D2)/ (D1-B)]*100.
Measured: Baseline to 4 hours
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 amount of F divided by volume of the enamel cores and expressed as micrograms (μg)* F/centimeters(cm)^2. Difference between treatments was calculated with respect to F uptake by enamel.
Measured: Baseline to 4 hours

Timeline

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

Feb 2012May 2012

First posted30 May 2012 (estimated)
Study startFeb 2012
Primary completionMay 2012
Study completionMay 2012

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 Dental 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: 55 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01607411
Sponsor's protocol ID: RH01390
Status last verified: Jul 2014
First submitted: 16 Feb 2012
Last updated: 11 Aug 2014
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.
PubMed 24283282

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?

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Study at a glance

From the registry record, last updated by the sponsor on 11 Aug 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Study to Evaluate Experimental Children's Toothpastes in an In-Situ Caries Model
ClinicalTrials.gov ID: NCT01607411
Acronym / sponsor ID: RH01390
Conditions: Dental Caries
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 55 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2012
Primary completion: May 2012 (actual)
Study completion: May 2012 (actual)
First posted: 30 May 2012 (estimated)
Results: Posted 26 Aug 2013

Clinical summary

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

An in situ model will be used to evaluate and compare enamel remineralization of human enamel specimens after single use of experimental children's toothpastes.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Single blind (investigator)
Number of arms: 4

Arm	Type	Receives
Fluoride free toothpaste	Placebo comparator	Drug: Placebotoothpaste with no fluoride
1426ppm Fluoride Toothpaste	Experimental	Drug: FluorideExperimental toothpaste containing 1426 ppm Fluoride
1000 ppm Fluoride Toothpaste	Experimental	Drug: FluorideExperimental toothpaste containing 1000 ppm Fluoride
500 ppm Toothpaste	Experimental	Drug: FluorideExperimental toothpaste containing 500 ppm Fluoride

Who may qualify

Ages: 11 to 14 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child

Key inclusion criteria (1 listed)

Healthy males and females aged 11 to 14 inclusive who have an unstimulated salivary flow rate of at least 0.2 mL/minute and a stimulated salivary flow rate of at least 0.8 mL/minute (Screening Visit 1).

Key exclusion criteria (1 listed)

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
FluorideFluoride Toothpaste	Drug	1000 ppm Fluoride Toothpaste, 1426ppm Fluoride Toothpaste, 500 ppm Toothpaste
PlaceboFluoride free toothpaste	Drug	Fluoride free toothpaste

Primary outcome

Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice
Time frame: Baseline to 4 hours
Surface microhardness recovery (SMHR) test was used to assess the changes in 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. Percent SMHR was calculated from indentation values of enamel specimens at baseline (B), after in-situ hardening (R) and after first demineralization challenge (D1) using formula: [(D1-R)/ (D1-B)]*100.

3 secondary outcomes

%SMHR of Enamel Specimens Exposed to Test Treatments
Time frame: Baseline to 4 hours
Percent Net Acid Resistance (%NAR) of Enamel Specimens
Time frame: Baseline to 4 hours
Enamel Fluoride Uptake
Time frame: Baseline to 4 hours

Results and safety

Results posted to the registry on 26 Aug 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)	14	14
NaF Toothpaste (1000 Ppm F)	13	13
NaF Toothpaste (500 Ppm F)	14	14
Placebo Toothpaste (0 Ppm F)	14	14

Primary outcome: Percentage Surface Microhardness Recovery of Test Dentifrices Relative to Placebo Dentifrice

Time frame: Baseline to 4 hours. Mean (Standard Error). Unit: %SMHR

Measure	NaF Toothpaste (1426 Ppm F) n = 55	NaF Toothpaste (1000 Ppm F) n = 55	NaF Toothpaste (500 Ppm F) n = 55	Placebo Toothpaste (0 Ppm F) n = 55
Value	30.72 (0.87)	29.49 (0.87)	28.29 (0.87)	25.13 (0.87)

NaF Toothpaste (1426 Ppm F) vs Placebo Toothpaste (0 Ppm F): Adjusted Mean Difference: 5.59 (95% CI 3.60 to 7.58), p <0.0001, ANOVA
NaF Toothpaste (1000 Ppm F) vs Placebo Toothpaste (0 Ppm F): Adjusted Mean Difference: 4.36 (95% CI 2.37 to 6.35), p <0.0001, ANOVA
NaF Toothpaste (500 Ppm F) vs Placebo Toothpaste (0 Ppm F): Adjusted Mean Difference: 3.16 (95% CI 1.17 to 5.15), p = 0.0021, ANOVA

Population analysed: Per Protocol (PP) Population: All randomized participants who received at least one study product, had one efficacy assessment and did not have any protocol violations deemed to affect efficacy. Missing enamel specimen values were imputed, by averaging over the available enamel specimens.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Baseline through 5 days post administration of last treatment. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
NaF Toothpaste (1426 Ppm F)	0 of 55 (0%)	4 of 55 (7.3%)	Not reported
NaF Toothpaste (1000 Ppm F)	0 of 55 (0%)	6 of 55 (10.9%)	Not reported
NaF Toothpaste (500 Ppm F)	0 of 55 (0%)	7 of 55 (12.7%)	Not reported
Placebo Toothpaste (0 Ppm F)	0 of 55 (0%)	6 of 55 (10.9%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 24283282Newby EE, Martinez-Mier EA, Hara A, Lippert F, Kelly SA, Fleming N, Butler A, Bosma ML, Zero DT. A randomised clinical study to evaluate experimental children's toothpastes in an in-situ palatal caries model in children aged 11-14 years. Int Dent J. 2013 Dec;63 Suppl 2(Suppl 2):31-8. doi: 10.1111/idj.12073.

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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 Phase 3 study testing Fluoride in people with Dental 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 1 inclusion and 1 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 11 Aug 2014. 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 26 Aug 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 of Test Dentifrices Relative to Placebo Dentifrice (time frame: Baseline to 4 hours). 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 NCT01607411, 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 11 Aug 2014.