Evaluate Clinical Research From Commerical Oral Care Products

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

PHASE3

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2008-04-30

Brief Summary

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The purpose of this study is to conduct a clinical study comparing anti-plaque efficacy of commercial oral care products.

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Detailed Description

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The purpose of this study is to compare efficacy of two commercially available toothpastes and one oral rinse on dental plaque control.

Conditions

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Gingival Diseases

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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A

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush twice daily

B

Group Type ACTIVE_COMPARATOR

Triclosan/Fluoride

Intervention Type DRUG

Half mouth toothbrushing twice daily for 4 days

C

Group Type ACTIVE_COMPARATOR

Chlorhexidine Gluconate

Intervention Type DRUG

Mouth rinsing twice a day for 4 days

Interventions

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Fluoride

Brush twice daily

Intervention Type DRUG

Triclosan/Fluoride

Half mouth toothbrushing twice daily for 4 days

Intervention Type DRUG

Chlorhexidine Gluconate

Mouth rinsing twice a day for 4 days

Intervention Type DRUG

Other Intervention Names

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monofluorophosphate sodium fluoride triclosan Chlorhexidine Gluconate oral rinse

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

* Subjects 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 or heavy dental tartar (calculus) requiring more than one visit of cleaning sessions
* 2 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 can 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.
* Allergy to chlorhexidine
* 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.
* 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