Collection of Gingival Crevicular Fluid From Periodontitis Patients

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

39 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-03-31

Study Completion Date

2008-04-30

Brief Summary

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To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

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Detailed Description

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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

SINGLE

Participants

Study Groups

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A -Control

Fluoride toothpaste (Colgate Great Regular Flavor) is the control for this study. All study toothpastes contain fluoride. The study is evaluating the additional ingredients in the other toothpastes.

Group Type PLACEBO_COMPARATOR

Fluoride

Intervention Type DRUG

Brush twice daily for 6 weeks

B

fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)

Group Type ACTIVE_COMPARATOR

Fluoride, triclosan

Intervention Type DRUG

Brush twice daily

Interventions

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Fluoride

Brush twice daily for 6 weeks

Intervention Type DRUG

Fluoride, triclosan

Brush twice daily

Intervention Type DRUG

Other Intervention Names

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Coglate Great Regular Flavor toothpaste Colgate Total toothpaste

Eligibility Criteria

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Inclusion Criteria

* Be aged 18 to 65 years inclusive
* Have a minimum of 20 natural uncrowned teeth (excluding 3rd molars) present
* Give written informed consent
* Be in good general health
* No known history of allergy to personal care/consumer products or their
* ingredients, relevant to any ingredients in the test products as determined by the
* dental/medical professional monitoring the study

Exclusion Criteria

* Medical condition which requires pre-medication prior to dental visits/procedures
* Advanced periodontal disease
* 5 or more decayed, untreated dental sites
* Diseases of the soft or hard oral tissues
* Orthodontic appliances
* Abnormal salivary function
* Use of prescription drugs.
* Use of antibiotics one (1) month prior to or during this study
* Use of any over the counter medications other than analgesics
* Erratic use of vitamin supplements
* Pregnant or breastfeeding.
* Participation in another clinical study in the month preceding this study
* Allergic to common dentifrice ingredients
* Immune compromised individuals (HIV, AIDS, immuno suppressive drug therapy)

Minimum Eligible Age

26 Years

Maximum Eligible Age

68 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes