Compare the Clinical Efficacy of Prototype Toothpastes

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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Clinical study to compare the clinical efficacy of toothpastes on dental plaque and gingival inflammation.

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Detailed Description

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Conditions

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Dental Plaque

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Fluoride control -A

Winterfresh Gel

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush twice daily

Triclosan/Fluoride - B

Positive control (Total toothpaste)

Group Type ACTIVE_COMPARATOR

Triclosan, fluoride

Intervention Type DRUG

Brush twice daily

Triclosan/fluoride/metal salt- C

test toothpaste

Group Type EXPERIMENTAL

Metal salt

Intervention Type OTHER

Brush twice daily

Interventions

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Fluoride

Brush twice daily

Intervention Type DRUG

Triclosan, fluoride

Brush twice daily

Intervention Type DRUG

Metal salt

Brush twice daily

Intervention Type OTHER

Other Intervention Names

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Colgate Winterfresh Gel Colgate Total toothpaste New toothpaste formula being evaluated.

Eligibility Criteria

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Inclusion Criteria

* Male or female volunteers 18-65 years of age.
* Good general health.
* Must sign informed consent form.
* Minimum of 20 natural uncrowned teeth (excluding third molars) must be present.
* No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria

* Subject unable or unwilling to sign the informed consent form.
* Medical condition which requires pre-medication prior to dental visits/procedures.
* Moderate or advanced periodontal disease.
* 5 or more decayed untreated dental sites at screening.
* Other disease of the hard or soft oral tissues.
* Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
* Use of medications that currently affect salivary flow.
* Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
* Pregnant or nursing women.
* Participation in any other clinical study within 1 week prior to enrollment into this study.
* Use of tobacco products.
* Subjects who must receive dental treatment during the study dates.
* Current use of Antibiotics for any purpose.
* Presence of an orthodontic appliance.
* History of allergy to common dentifrice ingredients.
* History of allergy to zinc.
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy).

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes