Investigate Oral Bacteria in Adult Population

Phase 3

Completed

Conditions: Oral Bacteria

Interventions: Drug: Fluoride
Drug: Fluoride, Triclosan
Drug: Stannous Fluoride

Registration Number: NCT00762177

Lead Sponsor: Colgate Palmolive

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

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 24

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
A -Control	Fluoride	fluoride toothpaste
C- positive control	Fluoride, Triclosan	fluoride/triclosan/copolymer toothpaste
B Experimental toothpaste	Stannous Fluoride	Stannous fluoride toothpaste

Primary Outcome Measures

Name	Time	Method
Antimicrobial Species in Saliva(Total Anaerobic)	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
Antimicrobial Species in Tongue(Total Anaerobic)	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.
Antimicrobial Species on the Cheek(Total Anaerobic)	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.
Antimicrobial Species in Plaque(Fusobacteria)	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.
Antimicrobial Species in Saliva(Fusobacteria)	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.
Antimicrobial Species in Plaque(Actinomyces)	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
Antimicrobial Species in Saliva(Actinomyces)	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
Antimicrobial Species on the Tongue(Actinomycetes)	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
Antimicrobial Species on the Cheek(Actinomyces)	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
Antimicrobial Species in Plaque(Total Anaerobic)	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
Antimicrobial Species in Tongue(Fusobacteria)	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.
Antimicrobial Species on the Cheek(Fusobacteria)	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.
Antimicrobial Species in Plaque(Oral Streptococci)	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.
Antimicrobial Species in Saliva(Oral Streptococci)	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.
Antimicrobial Species in Tongue(Oral Streptococci)	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.
Antimicrobial Species on the Cheek(Oral Streptococci)	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
Antimicrobial Species in Plaque(Sulfur Bacteria)	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.
Antimicrobial Species in Saliva(Sulfur Bacteria)	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.
Antimicrobial Species in Tongue(Sulfur Bacteria)	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.
Antimicrobial Species on the Cheek(Sulfur Bacteria)	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.
Antimicrobial Species in Plaque(Veillonella)	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.
Antimicrobial Species in Saliva(Veillonella)	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.
Antimicrobial Species in Tongue(Veillonella)	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.
Antimicrobial Species on the Cheek(Veillonella)	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.