Efficacy of Salivary Bacteria and Post Brushing

Phase 3

Completed

• Conditions: Salivary Bacteria Levels
• Interventions: Drug: Triclosan/Fluoride; Drug: Fluoride

• Registration Number: NCT00981825
• Lead Sponsor: Colgate Palmolive

Brief Summary

Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing

Detailed Description

Not available

Study Timeline

• Study Start: 2007-10
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Study First Submitted: 2008-09-26
• Results First Submitted: 2008-09-26
• Study First Submitted QC: 2009-08-14
• Results First Submitted QC: 2009-08-14
• Study First Posted: 2009-09-22
• Results First Posted: 2009-09-22
• Status Verified: 2011-06
• Last Update Submitted: 2011-06-10
• Last Update Posted: 2011-06-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

Inclusion Criteria

• Male or female volunteers 18-65 years of age
• Good general health
• Must sign informed consent form
• Must discontinue oral hygiene on the mornings of each appointment and between sampling periods.
• No history of allergy to personal care consumer products, or their ingredients, relevant to any ingredient in the test products as determined by the dental/medical professional monitoring the study.

Exclusion Criteria

• Medical condition which requires pre-medication prior to dental procedures/visits
• Medical condition which precludes eating/drinking for 12 hrs.
• History of allergy to common dentifrice ingredients
• Subjects unable or unwilling to sign the informed consent form.
• Moderate or advanced periodontal disease.
• 2 or more decayed untreated dental sites at screening.
• Other disease of the hard or soft oral tissues.
• Impaired salivary function (e.g. Sjogren's syndrome or head and neck irradiation).
• Use of medications that can currently affect salivary flow
• Current use of antibiotics
• Use of antibiotics or antimicrobial drugs within 30 days prior to study visit #1.
• Pregnant or nursing women.
• Participation in any other clinical study within 30 days prior to enrollment into this study.
• Use of tobacco products
• Subjects who must receive dental treatment during the study dates.
• Current use of Antibiotics for any purpose.
• Immune compromised individuals (HIV,AIDS, immuno suppressive drug therapy)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
B	Triclosan/Fluoride	triclosan/fluoride toothpaste
A	Fluoride	fluoride toothpaste control

Primary Outcome Measures

Name	Time	Method
CFU (Colony Forming Units)	4 hours	Total number of salivary bacterial colony forming units (lower number = less colonies present)

Trial Locations

Locations (1)

India GTC, Colgate Palmolive(I) ltd; 🇮🇳 Mumbai, India