Collection of Gingival Crevicular Fluid From Periodontitis Patients
- Registration Number
- NCT00763048
- Lead Sponsor
- Colgate Palmolive
- Brief Summary
To collect GCF (gingival crevicular fluid) samples from diseased patients suffering only from gingivitis and/or periodontitis.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 39
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description A -Control Fluoride 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. B Fluoride, triclosan fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)
- Primary Outcome Measures
Name Time Method Metabolite Associated With Inflammation (Cadaverine) 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.
Metabolite Associated With Inflammation (Choline) 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.
Metabolite Associated With Inflammation (Hypoxanthine) 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.
Metabolite Associated With Inflammation (Inosine) 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.
Metabolite Associated With Inflammation (Isoleucine) 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.
Metabolite Associated With Inflammation (Leucine) 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.
Metabolite Associated With Inflammation (Lysine) 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.
Metabolite Associated With Inflammation (Phenylalanine) 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.
Metabolite Associated With Inflammation (Putrescine) 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.
Metabolite Associated With Inflammation (Xanthine) 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Forsyth Institute
🇺🇸Boston, Massachusetts, United States