Collection of Gingival Crevicular Fluid From Periodontitis Patients

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

Official Title
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Collection of Gingival Crevicular Fluid From Periodontitis Patients

Conditions
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Gingival Diseases

Intervention / Treatment
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* Drug: Fluoride
* Drug: Fluoride, triclosan


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 26 Years
Maximum Age: 68 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: A -Control<br>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<br>* Brush twice daily for 6 weeks<br>* Other names: Coglate Great Regular Flavor toothpaste;|
| Active Comparator: B<br>fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste) | Drug: Fluoride, triclosan<br>* Brush twice daily<br>* Other names: Colgate Total toothpaste;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 |