Collection of Gingival Crevicular Fluid From Periodontitis Patients

Gingival Diseases Clinical Trial

Official title:

Collection of Gingival Crevicular Fluid From Periodontitis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00763048
• Other study ID #: CRO-2007-GIN-05-GB
• Status: Completed
• Phase: Phase 3
• First received: September 26, 2008
• Last updated: June 10, 2011
• Start date: March 2008
• Est. completion date: April 2008

Study information

• Verified date: June 2011
• Source: Colgate Palmolive
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 39
• Est. completion date: April 2008
• Est. primary completion date: April 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 26 Years to 68 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Gingival Diseases
• Periodontal Diseases
• Periodontitis

Intervention

Drug:
• Fluoride
Brush twice daily for 6 weeks
• Fluoride, triclosan
Brush twice daily

Locations

Country	Name	City	State
United States	Forsyth Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Colgate Palmolive

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Metabolite Associated With Inflammation (Cadaverine)	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	No
Primary	Metabolite Associated With Inflammation (Choline)	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	No
Primary	Metabolite Associated With Inflammation (Hypoxanthine)	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	No
Primary	Metabolite Associated With Inflammation (Inosine)	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	No
Primary	Metabolite Associated With Inflammation (Isoleucine)	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	No
Primary	Metabolite Associated With Inflammation (Leucine)	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	No
Primary	Metabolite Associated With Inflammation (Lysine)	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	No
Primary	Metabolite Associated With Inflammation (Phenylalanine)	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	No
Primary	Metabolite Associated With Inflammation (Putrescine)	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	No
Primary	Metabolite Associated With Inflammation (Xanthine)	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	No