Investigate Oral Bacteria in Adult Population

NCT00762177 | Completed Phase 3 Results

• 1 other identifier: CRO-0108-BACT-PS-NJ
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the antimicrobial efficacy of three dentifrices on oral bacteria

Conditions

Oral Bacteria

Outcome Measures

Primary Outcomes (24)

• Antimicrobial Species in Plaque(Actinomyces)

  After 14 days of study product use, dental plaque was scraped from the subject's teeth. The plaque was placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar

  14 days

• Antimicrobial Species in Saliva(Actinomyces)

  Saliva was collected, after 14 days of product use, by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar

  14 days

• Antimicrobial Species on the Tongue(Actinomycetes)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar

  14 days

• Antimicrobial Species on the Cheek(Actinomyces)

  After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CFAT Agar

  14 days

• Antimicrobial Species in Plaque(Total Anaerobic)

  After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar

  14 days

• Antimicrobial Species in Saliva(Total Anaerobic)

  After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar

  14 days

• Antimicrobial Species in Tongue(Total Anaerobic)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.

  14 days

• Antimicrobial Species on the Cheek(Total Anaerobic)

  After 14 day of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on ETSA Agar.

  14 days

• Antimicrobial Species in Plaque(Fusobacteria)

  After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.

  14 days

• Antimicrobial Species in Saliva(Fusobacteria)

  After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.

  14 days

• Antimicrobial Species in Tongue(Fusobacteria)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.

  14 days

• Antimicrobial Species on the Cheek(Fusobacteria)

  After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on CVE Agar.

  14 days

• Antimicrobial Species in Plaque(Oral Streptococci)

  After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.

  14 days

• Antimicrobial Species in Saliva(Oral Streptococci)

  After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.

  14 days

• Antimicrobial Species in Tongue(Oral Streptococci)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar.

  14 days

• Antimicrobial Species on the Cheek(Oral Streptococci)

  After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Mitis Salivarius Agar

  14 days

• Antimicrobial Species in Plaque(Sulfur Bacteria)

  After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.

  14 days

• Antimicrobial Species in Saliva(Sulfur Bacteria)

  After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.

  14 days

• Antimicrobial Species in Tongue(Sulfur Bacteria)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.

  14 days

• Antimicrobial Species on the Cheek(Sulfur Bacteria)

  After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on OHO Agar.

  14 days

• Antimicrobial Species in Plaque(Veillonella)

  After 14 days of study product use, dental plaque scraped from teeth, placed in sterile phosphate buffered saline(PBS) and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.

  14 days

• Antimicrobial Species in Saliva(Veillonella)

  After 14 days of study product use, saliva was collected by drooling into a tube and sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in sterile phosphate buffered saline(PBS) and plated using a spiral systems autoplate 4000 spiral plater on veillonella Agar.

  14 days

• Antimicrobial Species in Tongue(Veillonella)

  After 14 days of study product use, the tongue was scraped 5 times with the edge of a tongue depressor. The sample is vortexed in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.

  14 days

• Antimicrobial Species on the Cheek(Veillonella)

  After 14 days of study product use, the inside of the cheek was scraped with a swab and place in sterile phosphate buffered saline(PBS) and the sample is then sonicated using a Branson 450A sonicator with a cup horn for 30 seconds. Samples diluted (10 fold) in PBS and plated using a spiral systems autoplate 4000 spiral plater on Veillonella Agar.

  14 days

Study Arms (3)

A -Control

PLACEBO COMPARATOR

fluoride toothpaste

Drug: Fluoride

B Experimental toothpaste

EXPERIMENTAL

Stannous fluoride toothpaste

Drug: Stannous Fluoride

C- positive control

ACTIVE COMPARATOR

fluoride/triclosan/copolymer toothpaste

Drug: Fluoride, Triclosan

Interventions

Fluoride DRUG

Brush twice a day for 14 days

Also known as: Crest Anti-Cavity toothpaste

A -Control

Fluoride, Triclosan DRUG

Brush twice daily for 14 days

Also known as: Total toothpaste

C- positive control

Stannous Fluoride DRUG

Brush twice daily for 14 days

B Experimental toothpaste

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females in good general health aged 18 to 70 years.
• A willingness to read, understand, and sign the Informed Consent Form after the nature of the study has been fully explained to them. Subject should demonstrate a willingness to comply with all study procedures and sampling schedules.
• A minimum of 20 natural teeth with facial and lingual scorable surfaces.
• Adequate oral hygiene and no signs of oral neglect.
• Good periodontal health. Enrolled subjects will have periodontal pockets no greater than 5 mm.
• Gingival and plaque indices will also be measured during the first visit. Subjects with gingival index greater than or equal to 1.5 (Lobene Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.

You may not qualify if:

• History of significant adverse effects following use of oral hygiene products such as toothpastes and mouthrinses. Allergy to personal care/consumer products or their ingredients. Previous known allergy to dental materials, particularly to acrylic-like materials used to fabricate the stent device (this is a highly unlikely occurrence).
• Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
• Difficulty having dental impressions taken such as excessive gagging.
• History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
• History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
• Subjects on antibiotic, antiinflammatory or anticoagulant therapy during the month preceding the baseline exam.
• Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).
• History of active severe periodontal disease with bleeding gums and loose teeth.
• Gross dental caries, severe generalized cervical abrasion and/or enamel abrasion, large fractured or temporary restorations (based on visual examinations).will not be included in the tooth count.
• Fixed or removable orthodontic appliance or removable partial dentures.
• Participation in a dental plaque/gingivitis clinical study involving oral care products, within the last 30 days. History of dental prophylaxis or treatments in the past month.
• Self reported pregnancy or lactation.
• History or current use of objects to pierce the lips or tongue.
• Subjects known to be an alcoholic, or a recovering alcoholic.
• History or current use of recreational drugs.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

Department of Oral Biology

Newark, New York, 07103-2714, United States

Location

MeSH Terms

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste; Tin Fluorides

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; Tin Compounds; Cariostatic Agents; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Results Point of Contact

• Title: William De Vizio
• Organization: Colgate Palmolive Co.

William_Devizio@colpal.com

732-878-7901

Study Officials

• Daniel Fine, DDS

  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: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 30, 2008
• Study Start: May 1, 2008
• Primary Completion: September 1, 2008
• Study Completion: September 1, 2008
• Last Updated: March 23, 2011
• Results First Posted: February 14, 2011

Record last verified: 2011-02

Locations

US (1)