Collection of Gingival Crevicular Fluid From Periodontitis Patients

Colgate-Palmolive

Status and phase: Completed; Phase 3

Conditions: Gingival Diseases

Treatments: Drug: Fluoride; Drug: Fluoride, triclosan

Study type: Interventional

Funder types: Industry

Identifiers

NCT00763048

CRO-2007-GIN-05-GB

Details and patient eligibility

About

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

Enrollment: 39 patients

Sex: All

Ages: 26 to 68 years old

Volunteers: Accepts Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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39 participants in 2 patient groups, including a placebo group

A -Control

Placebo Comparator group

Description:

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.

Treatment:

Drug: Fluoride

B

Active Comparator group

Description:

fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)

Treatment:

Drug: Fluoride, triclosan