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Completed

NCT Number: NCT00763048

Collection of Gingival Crevicular Fluid From Periodontitis Patients

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

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Key information

Conditions

Gingival Diseases Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

26 year–68 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Forsyth Institute

Boston, Massachusetts, 02115, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Fluoride

Drug

Brush twice daily for 6 weeks

Other names: Coglate Great Regular Flavor toothpaste

Fluoride, triclosan

Drug

Brush twice daily

Other names: Colgate Total toothpaste

Primary outcomes

  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.

Sponsors and collaborators

Lead sponsor

Colgate Palmolive

Industry

Registry information

Important dates

Study start
2008
Primary completion
2008
Study completion
2008
First posted
Sep 30, 2008
Registry last updated
Jun 14, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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