Collection of Gingival Crevicular Fluid From Periodontitis Patients

This study has been completed.
Sponsor:
Information provided by:
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT00763048
First received: September 26, 2008
Last updated: June 10, 2011
Last verified: June 2011
  Purpose

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


Condition Intervention Phase
Gingival Diseases
Drug: Fluoride
Drug: Fluoride, triclosan
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Collection of Gingival Crevicular Fluid From Periodontitis Patients

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Metabolite Associated With Inflammation (Cadaverine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Choline) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Hypoxanthine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Inosine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Isoleucine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Leucine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Lysine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Phenylalanine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Putrescine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.

  • Metabolite Associated With Inflammation (Xanthine) [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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.


Enrollment: 39
Study Start Date: March 2008
Study Completion Date: April 2008
Primary Completion Date: April 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Coglate Great Regular Flavor toothpaste
Active Comparator: B
fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)
Drug: Fluoride, triclosan
Brush twice daily
Other Name: Colgate Total toothpaste

  Eligibility

Ages Eligible for Study:   26 Years to 68 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00763048

Locations
United States, Massachusetts
Forsyth Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Colgate Palmolive
Investigators
Principal Investigator: Riccardo Teles, DMD
  More Information

No publications provided

Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00763048     History of Changes
Other Study ID Numbers: CRO-2007-GIN-05-GB
Study First Received: September 26, 2008
Results First Received: August 19, 2010
Last Updated: June 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gingival Diseases
Periodontitis
Mouth Diseases
Periodontal Diseases
Stomatognathic Diseases
Fluorides
Triclosan
Anti-Infective Agents
Anti-Infective Agents, Local
Antimetabolites
Cariostatic Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Lipid Regulating Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Protective Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014