Investigate Oral Bacteria in Adult Population

• 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: Colgate Palmolive
• Information provided by: Colgate Palmolive

Study Description

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

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Locations

United States, New York

Department of Oral Biology

Newark, New York, United States, 07103-2714

Sponsors and Collaborators

Colgate Palmolive

Investigators

• Principal Investigator: Daniel Fine, DDS

More Information

• Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
• ClinicalTrials.gov Identifier: NCT00762177
• Other Study ID Numbers: CRO-0108-BACT-PS-NJ
• First Posted: September 30, 2008
• Results First Posted: February 14, 2011
• Last Update Posted: March 23, 2011
• Last Verified: February 2011

Additional relevant 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