Phase 3 N=24 Randomized Single-blind Treatment

Investigate Oral Bacteria in Adult Population

Oral Bacteria

Bottom Line

View on ClinicalTrials.gov: NCT00762177 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Feb 2011

Primary outcome: Primary: Antimicrobial Species in Plaque(Actinomyces) — 0.023; 0.3881; 0.0538 log CFU (Colony forming units) — p=0.05

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Fluoride (Drug); Fluoride, Triclosan (Drug); Stannous Fluoride (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Colgate Palmolive
Primary completion: Sep 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY Antimicrobial Species in Plaque(Actinomyces)	0.023; 0.3881; 0.0538	0.05
PRIMARY Antimicrobial Species in Saliva(Actinomyces)	0.016; 0.3209; 0.1116	0.05
PRIMARY Antimicrobial Species on the Tongue(Actinomycetes)	-0.0132; 0.2612; -0.0536	0.05
PRIMARY Antimicrobial Species on the Cheek(Actinomyces)	0.0099; 0.2949; -0.1875	0.05
PRIMARY Antimicrobial Species in Plaque(Total Anaerobic)	-0.0629; 0.312; 0.0762	0.05
PRIMARY Antimicrobial Species in Saliva(Total Anaerobic)	-0.0247; 0.1505; 0.05	0.05
PRIMARY Antimicrobial Species in Tongue(Total Anaerobic)	-0.0445; 0.2691; 0.0926	0.05
PRIMARY Antimicrobial Species on the Cheek(Total Anaerobic)	-0.0551; 0.2009; -0.0531	0.05
PRIMARY Antimicrobial Species in Plaque(Fusobacteria)	-0.2973; 0.2703; -0.0095	0.05
PRIMARY Antimicrobial Species in Saliva(Fusobacteria)	-0.0096; 0.194; 0.0539	0.05
PRIMARY Antimicrobial Species in Tongue(Fusobacteria)	-0.0742; 0.377; 0.1668	0.05
PRIMARY Antimicrobial Species on the Cheek(Fusobacteria)	-0.0319; 0.1887; 0.111	0.05
PRIMARY Antimicrobial Species in Plaque(Oral Streptococci)	-0.0848; 0.2593; -0.0096	0.05
PRIMARY Antimicrobial Species in Saliva(Oral Streptococci)	-0.0436; 0.1445; 0.087	0.05
PRIMARY Antimicrobial Species in Tongue(Oral Streptococci)	-0.1284; 0.2233; 0.0525	0.05
PRIMARY Antimicrobial Species on the Cheek(Oral Streptococci)	0.0126; 0.2088; -0.0251	0.05
PRIMARY Antimicrobial Species in Plaque(Sulfur Bacteria)	0.0174; 0.3083; -0.0416	0.05
PRIMARY Antimicrobial Species in Saliva(Sulfur Bacteria)	-0.1213; 0.1556; -0.603	0.05
PRIMARY Antimicrobial Species in Tongue(Sulfur Bacteria)	-0.083; 0.2065; -0.0248	0.05
PRIMARY Antimicrobial Species on the Cheek(Sulfur Bacteria)	-0.1788; 0.2036; -0.0815	0.05
PRIMARY Antimicrobial Species in Plaque(Veillonella)	0.0007; 0.3658; 0.0316	0.05
PRIMARY Antimicrobial Species in Saliva(Veillonella)	0.0167; 0.3062; 0.0901	0.05
PRIMARY Antimicrobial Species in Tongue(Veillonella)	-0.002; 0.2724; -0.0424	0.05
PRIMARY Antimicrobial Species on the Cheek(Veillonella)	-0.0732; 0.2579; -0.0676	0.05

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.

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Data sourced from ClinicalTrials.gov (NCT00762177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.