Collection of Gingival Crevicular Fluid From Periodontitis Patients

June 10, 2011 updated by: Colgate Palmolive
To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Forsyth Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

26 years to 68 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: 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.
Drug: Fluoride
Brush twice daily for 6 weeks
Other Names:
  • Coglate Great Regular Flavor toothpaste
ACTIVE_COMPARATOR: B
fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)
Drug: Fluoride, triclosan
Brush twice daily
Other Names:
  • Colgate Total toothpaste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metabolite Associated With Inflammation (Cadaverine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Choline)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Hypoxanthine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Inosine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Isoleucine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Leucine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Lysine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Phenylalanine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Putrescine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present. Data is after 6 weeks use of the study treatment.
6 weeks
Metabolite Associated With Inflammation (Xanthine)
Time Frame: 6 weeks
One of 10 inflammation biomarkers found in gingival crevicular fluid (GCF) that are associated with inflammation that could lead to gingivitis. The number is a quantitative, normalized ion count from a mass spectral instrument. The lower the number the less inflammation may be present.Data is after 6 weeks use of the study treatment.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Colgate Palmolive

Investigators

  • Principal Investigator: Riccardo Teles, DMD

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2008

Primary Completion (ACTUAL)

April 1, 2008

Study Completion (ACTUAL)

April 1, 2008

Study Registration Dates

First Submitted

September 26, 2008

First Submitted That Met QC Criteria

September 26, 2008

First Posted (ESTIMATE)

September 30, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

June 14, 2011

Last Update Submitted That Met QC Criteria

June 10, 2011

Last Verified

June 1, 2011

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CRO-2007-GIN-05-GB

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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