Status:

COMPLETED

Collection of Gingival Crevicular Fluid From Periodontitis Patients

Lead Sponsor:

Colgate Palmolive

Conditions:

Gingival Diseases

Eligibility:

All Genders

26-68 years

Phase:

PHASE3

Brief Summary

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

Eligibility Criteria

Inclusion

  • 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

  • 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)

Key Trial Info

Start Date :

March 1 2008

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

April 1 2008

Estimated Enrollment :

39 Patients enrolled

Trial Details

Trial ID

NCT00763048

Start Date

March 1 2008

End Date

April 1 2008

Last Update

June 14 2011

Active Locations (1)

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Forsyth Institute

Boston, Massachusetts, United States, 02115