Clinical trial NCT00762177: Investigate Oral Bacteria in Adult Population
Official title: Investigate Oral Bacteria in Adult Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Oral Bacteria
Lead sponsor: Colgate Palmolive
Sponsor class: INDUSTRY
First posted: 2008-09-30
Enrollment: 24
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


Eligibility 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.

Primary outcomes:
measure: Antimicrobial Species in Plaque(Actinomyces)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Actinomyces)
timeFrame: 14 days
measure: Antimicrobial Species on the Tongue(Actinomycetes)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Actinomyces)
timeFrame: 14 days
measure: Antimicrobial Species in Plaque(Total Anaerobic)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Total Anaerobic)
timeFrame: 14 days
measure: Antimicrobial Species in Tongue(Total Anaerobic)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Total Anaerobic)
timeFrame: 14 days
measure: Antimicrobial Species in Plaque(Fusobacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Fusobacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Tongue(Fusobacteria)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Fusobacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Plaque(Oral Streptococci)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Oral Streptococci)
timeFrame: 14 days
measure: Antimicrobial Species in Tongue(Oral Streptococci)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Oral Streptococci)
timeFrame: 14 days
measure: Antimicrobial Species in Plaque(Sulfur Bacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Sulfur Bacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Tongue(Sulfur Bacteria)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Sulfur Bacteria)
timeFrame: 14 days
measure: Antimicrobial Species in Plaque(Veillonella)
timeFrame: 14 days
measure: Antimicrobial Species in Saliva(Veillonella)
timeFrame: 14 days
measure: Antimicrobial Species in Tongue(Veillonella)
timeFrame: 14 days
measure: Antimicrobial Species on the Cheek(Veillonella)
timeFrame: 14 days
Secondary outcomes:
Other outcomes:
Locations:
city: Newark
country: United States
facility: Department of Oral Biology
state: New York
Study officials:
name: Daniel Fine, DDS
role: PRINCIPAL_INVESTIGATOR
References: