Investigate Oral Bacteria in Adult Population

NCT ID: NCT00762177

Last Updated: 2011-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-05-31
• Study Completion Date: 2008-09-30

Brief Summary

To compare the antimicrobial efficacy of three dentifrices on oral bacteria

Conditions

Oral Bacteria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

A -Control

fluoride toothpaste

Group Type: PLACEBO_COMPARATOR

Fluoride

Intervention Type: DRUG

Brush twice a day for 14 days

B Experimental toothpaste

Stannous fluoride toothpaste

Group Type: EXPERIMENTAL

Stannous Fluoride

Intervention Type: DRUG

Brush twice daily for 14 days

C- positive control

fluoride/triclosan/copolymer toothpaste

Group Type: ACTIVE_COMPARATOR

Fluoride, Triclosan

Intervention Type: DRUG

Brush twice daily for 14 days

Interventions

Fluoride

Brush twice a day for 14 days

Intervention Type: DRUG

Fluoride, Triclosan

Brush twice daily for 14 days

Intervention Type: DRUG

Stannous Fluoride

Brush twice daily for 14 days

Intervention Type: DRUG

Other Intervention Names

Crest Anti-Cavity toothpaste; Total toothpaste

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Colgate Palmolive

INDUSTRY

Sponsor Role: lead

Responsible Party

Colgate Palmolive

Principal Investigators

Daniel Fine, DDS

Role: PRINCIPAL_INVESTIGATOR

Locations

Department of Oral Biology

Newark, New York, United States

Countries

United States

Other Identifiers

CRO-0108-BACT-PS-NJ

Identifier Type: -

Identifier Source: org_study_id