Efficacy of Salivary Bacteria and Post Brushing

NCT00981825 | Completed Phase 3 Results

• 1 other identifier: ER0-2007-SAL-01-GX
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Salivary Bacteria Levels

Outcome Measures

Primary Outcomes (1)

• CFU (Colony Forming Units)

  Total number of salivary bacterial colony forming units (lower number = less colonies present)

  4 hours

Study Arms (2)

A

PLACEBO COMPARATOR

fluoride toothpaste control

Drug: Fluoride

B

ACTIVE COMPARATOR

triclosan/fluoride toothpaste

Drug: Triclosan/Fluoride

Interventions

Fluoride DRUG

Whole mouth brushing for 7 days

Also known as: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)

A

Triclosan/Fluoride DRUG

Brush whole mouth twice daily for 7 days

Also known as: triclosan/fluoride toothpaste (Colgate Total toothpaste)

B

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• Colgate Palmolive: lead

Study Sites (1)

India GTC, Colgate Palmolive(I) ltd

Mumbai, India

Location

MeSH Terms

Interventions

Fluorides; Triclosan; hydrated silica gel-based toothpaste

Intervention Hierarchy (Ancestors)

Anions; Ions; Electrolytes; Inorganic Chemicals; Hydrofluoric Acid; Fluorine Compounds; Phenyl Ethers; Ethers; Organic Chemicals; Phenols; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Results Point of Contact

• Title: William DeVizio - DMD
• Organization: Colgate Palmolive

william_devizio@colpal.com

732-878-7901

Study Officials

• Neelim Utgikar, DDS

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: GT60
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: September 26, 2008
• First Posted: September 22, 2009
• Study Start: October 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: June 14, 2011
• Results First Posted: September 22, 2009

Record last verified: 2011-06

Locations

IN (1)