CariesPhase 2NCT01657877

Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice

A Phase 2 study testing Calcium sodium phosphosilicate and Sodium monoflurophosphate 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.

Official record

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Trial summary

In situ study to compare treatment effect on enamel remineralization potential, measured by surface microhardness recovery (SMHR) and Enamel Fluoride Uptake (EFU). The study will explore the efficacy of an experimental sodium monofluorophosphate (SMFP) dentifrice containing calcium sodium phosphosilicate (CSP) in… 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?: Calcium sodium phosphosilicate and Sodium monoflurophosphate
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 100 participants
Where: 1 siteUnited States
Study dates: May 2012to Jun 2013
Phase: Phase 2
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

Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].

Who cannot join

None listed.

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: In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice

Conditions: Caries
Being tested: Calcium sodium phosphosilicate, Sodium monoflurophosphate, Placebo

What participants receive

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

Calcium sodium phosphosilicateDrug
CSP high percentage weight by weight
Sodium monoflurophosphateDrug
500 to 1500 parts per million (ppm) of fluoride
PlaceboDrug
No CSP and no fluoride

Study groups in NCT01657877
Study group	Role	What they receive
CSP/SMFP Dentifrice	Experimental	Dentifrice containing high fluoride content as SMFP and CSP Receives: Drug: Calcium sodium phosphosilicate; Drug: Sodium monoflurophosphate
SMFP Dentifrice Prototype 1	Active comparator	Dentifrice containing high fluoride content as SMFP and no CSP Receives: Drug: Sodium monoflurophosphate
SMFP Dentifrice Prototype 2	Active comparator	Dentifrice containing low fluoride content as SMFP and no CSP Receives: Drug: Sodium monoflurophosphate
CSP Dentifrice	Active comparator	Dentifrice containing CSP but no fluoride Receives: Drug: Calcium sodium phosphosilicate
Placebo Dentifrice	Placebo comparator	Dentifrice containing no CSP and no fluoride Receives: Drug: Placebo

What is being measured

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

Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
Percent SMH recovery (SMHR) was calculated from hardness 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. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Measured: Baseline to 21 days

Secondary outcomes (2)

Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.
Percent SMH recovery (SMHR) was calculated from hardness 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. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.
Measured: Baseline to 21 days
Enamel Fluoride Uptake (EFU)
Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.
Measured: Baseline to 21 days

Timeline

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

May 2012Jun 2013

First posted6 Aug 2012 (estimated)
Study startMay 2012
Primary completionJun 2013
Study completionJun 2013

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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind
Who is masked: Investigator, Outcomes assessor
Enrolment: 100 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01657877
Sponsor's protocol ID: RH01381
Status last verified: Sep 2014
First submitted: 2 Aug 2012
Last updated: 1 Oct 2014
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?

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Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: In Situ Study to Confirm the Anti-caries Potential of a 1.1365% w/w Sodium Monofluorophosphate (1500ppm F) Dentifrice
ClinicalTrials.gov ID: NCT01657877
Acronym / sponsor ID: RH01381
Conditions: Caries
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 100 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: May 2012
Primary completion: Jun 2013 (actual)
Study completion: Jun 2013 (actual)
First posted: 6 Aug 2012 (estimated)
Results: Posted 24 Jul 2014

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: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: Double blind (investigator, outcomes assessor)
Number of arms: 5

Arm	Type	Receives
CSP/SMFP Dentifrice	Experimental	Drug: Calcium sodium phosphosilicate, Drug: Sodium monoflurophosphateDentifrice containing high fluoride content as SMFP and CSP
SMFP Dentifrice Prototype 1	Active comparator	Drug: Sodium monoflurophosphateDentifrice containing high fluoride content as SMFP and no CSP
SMFP Dentifrice Prototype 2	Active comparator	Drug: Sodium monoflurophosphateDentifrice containing low fluoride content as SMFP and no CSP
CSP Dentifrice	Active comparator	Drug: Calcium sodium phosphosilicateDentifrice containing CSP but no fluoride
Placebo Dentifrice	Placebo comparator	Drug: PlaceboDentifrice containing no CSP and no fluoride

Who may qualify

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

Key inclusion criteria (1 listed)

Wears a removable bilateral mandibular partial denture that has good stability and support, with sufficient room on each side in the posterior buccal flange area to accommodate two enamel specimens [required dimensions 12 x 7 millimeters (mm)].

Key exclusion criteria (0 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
Calcium sodium phosphosilicateCSP high percentage weight by weight	Drug	CSP Dentifrice, CSP/SMFP Dentifrice
Sodium monoflurophosphate500 to 1500 parts per million (ppm) of fluoride	Drug	CSP/SMFP Dentifrice, SMFP Dentifrice Prototype 1, SMFP Dentifrice Prototype 2
PlaceboNo CSP and no fluoride	Drug	Placebo Dentifrice

Primary outcome

Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.
Time frame: Baseline to 21 days
Percent SMH recovery (SMHR) was calculated from hardness 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. A greater percentage change in SMHR represents a better remineralisation and hence a better outcome.

2 secondary outcomes

Percentage (%) Change in SMH Following 21 Days of Twice Daily Treatment With 500 Ppm Fluoride as SMFP and 0 % CSP Dentifrice, 0 Ppm Fluoride and 0% CSP, and 0 Ppm Fluoride and 5 % CSP.
Time frame: Baseline to 21 days
Enamel Fluoride Uptake (EFU)
Time frame: Baseline to 21 days

Results and safety

Results posted to the registry on 24 Jul 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Overall Participants	79	65

Primary outcome: Percentage (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice.

Time frame: Baseline to 21 days. Mean (Standard Error). Unit: Percentage SMHR

Measure	Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP n = 70	Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP n = 75
Value	30.15 (2.447)	32.32 (2.673)

Dentifrice Containing 1500ppm Fluoride as SMFP + 0% CSP vs Dentifrice Containing 1500ppm Fluoride as SMFP + 5 % CSP: Adjusted mean difference: -2.23 (95% CI -6.11 to 1.66), p = 0.2601, ANOVA

Population analysed: Per protocol (PP) population: The per protocol (PP) population was defined as those subjects in the intention to treat population who did not have protocol violations leading to exclusion of all efficacy data from analyses. Missing data was not imputed.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected from the start of the investigational product (or washout product), and until 5 days following last administration of the investigational product.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 5% CSP	1 of 75 (1.3%)	18 of 75 (24%)	Not reported
Dentifrice Containing 1500 Ppm Fluoride as SMFP + 0% CSP	0 of 71 (0%)	13 of 71 (18.3%)	Not reported
Dentifrice Containing 500 Ppm Fluoride as SMFP + 0% CSP	2 of 70 (2.9%)	14 of 70 (20%)	Not reported
Dentifrice Containing 0 Ppm Fluoride + 0% CSP	0 of 69 (0%)	11 of 69 (15.9%)	Not reported
Dentifrice Containing 0 Ppm Fluoride + 5% CSP	0 of 71 (0%)	13 of 71 (18.3%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2014.
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

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Calcium sodium phosphosilicate and Sodium monoflurophosphate 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 1 inclusion and 0 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 Oct 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 Jul 2014). 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 (%) Change in Surface Microhardness (SMH) Following 21 Days of Twice Daily Treatment With the 1500 Ppm Fluoride + 5% CSP Dentifrice and With the 1500 Ppm Fluoride Dentifrice. (time frame: Baseline to 21 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 NCT01657877.

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 Oct 2014.