Enamel Remineralization Potential of Dentifrices in Situ

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-03-31

Brief Summary

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This study will use an oral in-situ caries model to study remineralization of enamel due to the action of different combinations of fluoride salts delivered from dentifrices.

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Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Fluoride Toothpaste 1

Fluoride toothpaste containing sodium fluoride (NaF)

Group Type EXPERIMENTAL

NaF

Intervention Type DRUG

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

Fluoride Toothpaste 2

Fluoride toothpaste containing stannous fluoride (SnF) and NaF.

Group Type EXPERIMENTAL

NaF

Intervention Type DRUG

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

SnF

Intervention Type DRUG

Fluoride toothpaste containing stannous fluoride (1100 ppmF)

Fluoride Toothpaste 3

Fluoride toothpaste containing sodium monofluorophosphate (NaMFP) and NaF.

Group Type EXPERIMENTAL

NaF

Intervention Type DRUG

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

NaMFP

Intervention Type DRUG

Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)

Reference Dentifrice

Low fluoride toothpaste containing NaF

Group Type ACTIVE_COMPARATOR

NaF

Intervention Type DRUG

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

Interventions

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NaF

Fluoride toothpaste containing sodium fluoride as 1450 parts per million (ppm) F, 675 ppmF, 450 ppmF, 350ppmF.

Intervention Type DRUG

SnF

Fluoride toothpaste containing stannous fluoride (1100 ppmF)

Intervention Type DRUG

NaMFP

Fluoride toothpaste containing sodium monofluorophosphate (1000 ppmF)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical or oral health.
* No current active caries or periodontal disease that may compromise the study or health of the subject.
* All restorations in a good state of repair
* Currently wearing a removable mandibular partial denture with sufficient room in the posterior buccal flange area to accomodate two enamel specimens required dimensions 12 x 7 mm.
* Willing to have their denture modified to accomodate enamel test specimens
* Willing and capable of wearing removable mandibular partial dentures 24 hours per day during the treatment periods.
* Salivary flow rate in the range of normal values (unstimulated whole saliva flow rate greater than or equal to 0.2 mL/ minute; gum base stimulated whole saliva flow rate greater than or equal to 0.8 mL/minute.

Exclusion Criteria

* Individuals currently taking antibiotics, or who have taken antibiotics within 30 days prior to the first treatment visit.
* Current active caries or periodontal disease that may compromise the study or health of the subject.

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes