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Collection of Gingival Crevicular Fluid From Periodontitis Patients

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ClinicalTrials.gov Identifier: NCT00763048
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : March 1, 2011
Last Update Posted : June 14, 2011
Sponsor:
Information provided by:
Colgate Palmolive

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

Condition or disease Intervention/treatment Phase
Gingival Diseases Drug: Fluoride Drug: Fluoride, triclosan Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 39 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Collection of Gingival Crevicular Fluid From Periodontitis Patients
Study Start Date : March 2008
Actual Primary Completion Date : April 2008
Actual Study Completion Date : April 2008

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Gum Disease
U.S. FDA Resources

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 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



Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.



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Ages Eligible for Study:   26 Years to 68 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00763048


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

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
First Posted: September 30, 2008    Key Record Dates
Results First Posted: March 1, 2011
Last Update Posted: June 14, 2011
Last Verified: June 2011

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