Skip to main content
OpenTrials
Completed

NCT Number: NCT01657877

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

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 comparison to an experimental SMFP only dentifrice.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Caries

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Indiana University School of Dentistry

Indianapolis, Indiana, 46202, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)].

Treatment and study plan

Calcium sodium phosphosilicate

Drug

CSP high percentage weight by weight

Sodium monoflurophosphate

Drug

500 to 1500 parts per million (ppm) of fluoride

Placebo

Drug

No CSP and no fluoride

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

    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. Enamel Fluoride Uptake (EFU)

    Time frame: Baseline to 21 days

    Change to EFU was determine using a microdrill enamel biopsy of the in situ enamel specimens.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Aug 6, 2012
Registry last updated
Oct 1, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.