Collection of Gingival Crevicular Fluid From Periodontitis Patients

NCT00763048 | Completed Phase 3 Results

• 1 other identifier: CRO-2007-GIN-05-GB
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gingival Diseases

Outcome Measures

Primary Outcomes (10)

• 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

Study Arms (2)

A -Control

PLACEBO COMPARATOR

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

B

ACTIVE COMPARATOR

fluoride/triclosan/copolymer toothpaste (Colgate Total Toothpaste)

Drug: Fluoride, triclosan

Interventions

Fluoride DRUG

Brush twice daily for 6 weeks

Also known as: Coglate Great Regular Flavor toothpaste

A -Control

Fluoride, triclosan DRUG

Brush twice daily

Also known as: Colgate Total toothpaste

B

Eligibility Criteria

• Age: 26 Years - 68 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Medical condition which requires pre-medication prior to dental visits/procedures
• Advanced periodontal disease
• 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)

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Forsyth Institute

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Gingival Diseases

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste

Condition Hierarchy (Ancestors)

Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William Devizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Riccardo Teles, DMD

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: LTE60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: March 1, 2008
• Primary Completion: April 1, 2008
• Study Completion: April 1, 2008
• Last Updated: June 14, 2011
• Results First Posted: March 1, 2011

Record last verified: 2011-06

Locations

US (1)