Evaluation of a Low-fluoride Anticaries Toothpaste

Evaluation of a Low-fluoride Anticaries Toothpaste Containing an Innovative Calcium Technology

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01094210

Enrollment

Registered

2010-03-26

Start date

2010-09-30

Completion date

2011-03-31

Last updated

2015-03-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Tooth Abnormality

Keywords

Anti-erosion dental benefits

Brief summary

The purpose of this trial is to evaluate the anticaries remineralizing potential of a toothpaste containing 500 ppm fluoride plus fTCP technology relative to a commercially available toothpaste via a double-blind cross-over in situ (or intra-oral) clinical model, whereby approved human participants will wear an orthodontic appliance fitted with an enamel specimen for the duration of a leg (28 days). There will be two test legs.

Interventions

DRUGFluorides, Topical

500 ppm F and 1100 ppm F topical toothpastes comprise sodium fluoride in each.

Study design

Observational model

CASE_CROSSOVER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 50 Years

Healthy volunteers

Yes

Inclusion criteria

* 30 adult subjects (between 18-50 years of age)

Design outcomes

Primary

Measure	Time frame	Description
Surface Microhardness	30 days	Strength measurements made at the enamel surface of the enamel specimen
Transverse Microradiography	30 days	X-ray analysis of enamel lesion
Cross-Sectional Microhardness	30 days	Strength measurements made within the enamel lesion of the enamel specimen

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026