Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Investigate Oral Bacteria in Adult Population

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00762177
Recruitment Status : Completed
First Posted : September 30, 2008
Results First Posted : February 14, 2011
Last Update Posted : March 23, 2011
Sponsor:
Information provided by:
Colgate Palmolive

Brief Summary:
To compare the antimicrobial efficacy of three dentifrices on oral bacteria

Condition or disease Intervention/treatment Phase
Oral Bacteria Drug: Fluoride Drug: Fluoride, Triclosan Drug: Stannous Fluoride Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Investigate Oral Bacteria in Adult Population
Study Start Date : May 2008
Actual Primary Completion Date : September 2008
Actual Study Completion Date : September 2008

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: A -Control
fluoride toothpaste
Drug: Fluoride
Brush twice a day for 14 days
Other Name: Crest Anti-Cavity toothpaste

Experimental: B Experimental toothpaste
Stannous fluoride toothpaste
Drug: Stannous Fluoride
Brush twice daily for 14 days

Active Comparator: C- positive control
fluoride/triclosan/copolymer toothpaste
Drug: Fluoride, Triclosan
Brush twice daily for 14 days
Other Name: Total toothpaste




Primary Outcome Measures :
  1. Antimicrobial Species in Plaque(Actinomyces) [ Time Frame: 14 days ]
    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

  2. Antimicrobial Species in Saliva(Actinomyces) [ Time Frame: 14 days ]
    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

  3. Antimicrobial Species on the Tongue(Actinomycetes) [ Time Frame: 14 days ]
    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

  4. Antimicrobial Species on the Cheek(Actinomyces) [ Time Frame: 14 days ]
    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

  5. Antimicrobial Species in Plaque(Total Anaerobic) [ Time Frame: 14 days ]
    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

  6. Antimicrobial Species in Saliva(Total Anaerobic) [ Time Frame: 14 days ]
    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

  7. Antimicrobial Species in Tongue(Total Anaerobic) [ Time Frame: 14 days ]
    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.

  8. Antimicrobial Species on the Cheek(Total Anaerobic) [ Time Frame: 14 days ]
    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.

  9. Antimicrobial Species in Plaque(Fusobacteria) [ Time Frame: 14 days ]
    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.

  10. Antimicrobial Species in Saliva(Fusobacteria) [ Time Frame: 14 days ]
    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.

  11. Antimicrobial Species in Tongue(Fusobacteria) [ Time Frame: 14 days ]
    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.

  12. Antimicrobial Species on the Cheek(Fusobacteria) [ Time Frame: 14 days ]
    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.

  13. Antimicrobial Species in Plaque(Oral Streptococci) [ Time Frame: 14 days ]
    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. Antimicrobial Species in Saliva(Oral Streptococci) [ Time Frame: 14 days ]
    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.

  15. Antimicrobial Species in Tongue(Oral Streptococci) [ Time Frame: 14 days ]
    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.

  16. Antimicrobial Species on the Cheek(Oral Streptococci) [ Time Frame: 14 days ]
    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

  17. Antimicrobial Species in Plaque(Sulfur Bacteria) [ Time Frame: 14 days ]
    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.

  18. Antimicrobial Species in Saliva(Sulfur Bacteria) [ Time Frame: 14 days ]
    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.

  19. Antimicrobial Species in Tongue(Sulfur Bacteria) [ Time Frame: 14 days ]
    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.

  20. Antimicrobial Species on the Cheek(Sulfur Bacteria) [ Time Frame: 14 days ]
    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.

  21. Antimicrobial Species in Plaque(Veillonella) [ Time Frame: 14 days ]
    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.

  22. Antimicrobial Species in Saliva(Veillonella) [ Time Frame: 14 days ]
    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.

  23. Antimicrobial Species in Tongue(Veillonella) [ Time Frame: 14 days ]
    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.

  24. Antimicrobial Species on the Cheek(Veillonella) [ Time Frame: 14 days ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00762177


Locations
Layout table for location information
United States, New York
Department of Oral Biology
Newark, New York, United States, 07103-2714
Sponsors and Collaborators
Colgate Palmolive
Investigators
Layout table for investigator information
Principal Investigator: Daniel Fine, DDS

Layout table for additonal information
Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
ClinicalTrials.gov Identifier: NCT00762177     History of Changes
Other Study ID Numbers: CRO-0108-BACT-PS-NJ
First Posted: September 30, 2008    Key Record Dates
Results First Posted: February 14, 2011
Last Update Posted: March 23, 2011
Last Verified: February 2011
Additional relevant MeSH terms:
Layout table for MeSH terms
Triclosan
Fluorides
Tin Fluorides
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents