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

NCT ID: NCT01657877

Last Updated: 2014-10-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-05-31

Study Completion Date

2013-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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CSP/SMFP Dentifrice

Dentifrice containing high fluoride content as SMFP and CSP

Group Type EXPERIMENTAL

Calcium sodium phosphosilicate

Intervention Type DRUG

CSP high percentage weight by weight

Sodium monoflurophosphate

Intervention Type DRUG

500 to 1500 parts per million (ppm) of fluoride

SMFP Dentifrice Prototype 1

Dentifrice containing high fluoride content as SMFP and no CSP

Group Type ACTIVE_COMPARATOR

Sodium monoflurophosphate

Intervention Type DRUG

500 to 1500 parts per million (ppm) of fluoride

SMFP Dentifrice Prototype 2

Dentifrice containing low fluoride content as SMFP and no CSP

Group Type ACTIVE_COMPARATOR

Sodium monoflurophosphate

Intervention Type DRUG

500 to 1500 parts per million (ppm) of fluoride

CSP Dentifrice

Dentifrice containing CSP but no fluoride

Group Type ACTIVE_COMPARATOR

Calcium sodium phosphosilicate

Intervention Type DRUG

CSP high percentage weight by weight

Placebo Dentifrice

Dentifrice containing no CSP and no fluoride

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

No CSP and no fluoride

Interventions

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Calcium sodium phosphosilicate

CSP high percentage weight by weight

Intervention Type DRUG

Sodium monoflurophosphate

500 to 1500 parts per million (ppm) of fluoride

Intervention Type DRUG

Placebo

No CSP and no fluoride

Intervention Type DRUG

Eligibility Criteria

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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 \[required dimensions 12 x 7 millimeters (mm)\].
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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Indiana University School of Dentistry

Indianapolis, Indiana, United States

Site Status

Countries

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United States

Other Identifiers

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RH01381

Identifier Type: -

Identifier Source: org_study_id

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