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monoflurophosphate

Phase 2

Caries | Small molecule | ENT |GSK plc|Last Updated: Oct 1, 2014

Success Probability

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment100

FDA Designations

No designations recorded

Clinical trial landscape

monoflurophosphate · 1 trial · 1 indication

Phase 2 1
NCT01657877Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate DentifriceCaries
COMPLETED100 Analytics
PHASE2COMPLETED
Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice
CariesUnlock trial analytics

Study Endpoints

Primary Endpoints

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.
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.

Secondary Endpoints

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.
Baseline to 21 days
Enamel Fluoride Uptake (EFU)
Baseline to 21 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CSP/SMFP DentifriceEXPERIMENTALDentifrice containing high fluoride content as SMFP and CSP
SMFP Dentifrice Prototype 1ACTIVE_COMPARATORDentifrice containing high fluoride content as SMFP and no CSP
SMFP Dentifrice Prototype 2ACTIVE_COMPARATORDentifrice containing low fluoride content as SMFP and no CSP
CSP DentifriceACTIVE_COMPARATORDentifrice containing CSP but no fluoride
Placebo DentifricePLACEBO_COMPARATORDentifrice containing no CSP and no fluoride

Interventions

NameTypeDescription
Calcium sodium phosphosilicateDRUGCSP high percentage weight by weight
Sodium monoflurophosphateDRUG500 to 1500 parts per million (ppm) of fluoride
PlaceboDRUGNo CSP and no fluoride
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Eligibility Criteria

Age Range18 Years to 80 Years
SexALL
Healthy VolunteersYes
Study Sites1

Inclusion Criteria: * 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 \[required dimensions 12 x 7 millimeters (mm)\].

Countries:United States
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Frequently asked questions about monoflurophosphate

What is monoflurophosphate used for?

Monoflurophosphate is a small molecule being studied for the prevention of caries, or tooth decay. It is formulated as a dentifrice, meaning it is intended for use in toothpaste or similar oral care products. The drug is currently in Phase 2 clinical development for this indication.

Who makes monoflurophosphate?

Monoflurophosphate is being developed by GSK plc, a global pharmaceutical company listed on the London Stock Exchange under the ticker GSK. The company is conducting clinical research on this compound for the treatment of caries.

What phase is monoflurophosphate in?

Monoflurophosphate is in Phase 2 clinical development. It is an investigational drug and has not yet been approved for commercial use. A Phase 2 clinical trial has been completed to evaluate its anti-caries potential.

What clinical trials is monoflurophosphate in?

Monoflurophosphate has been studied in one clinical trial registered as NCT01657877. This Phase 2 trial, titled "Anti-caries Potential of a Sodium Monofluorophosphate and Calcium Sodium Phosphosilicate Dentifrice," was completed in the United States with 100 participants aged 18 years and older.

Is monoflurophosphate the same as sodium monofluorophosphate?

Yes, monoflurophosphate is also known as sodium monofluorophosphate. The clinical trial for this drug specifically evaluated a dentifrice containing sodium monofluorophosphate, which is the active ingredient being investigated for its anti-caries effects.