Efficacy of Salivary Bacteria and Post Brushing

• ClinicalTrials.gov Identifier: NCT00981825
• Recruitment Status: Completed
• First Posted: September 22, 2009
• Results First Posted: September 22, 2009
• Last Update Posted: June 14, 2011
• Sponsor: Colgate Palmolive
• Information provided by: Colgate Palmolive

Tracking Information

• First Submitted Date: September 26, 2008
• First Posted Date: September 22, 2009
• Results First Submitted Date: September 26, 2008
• Results First Posted Date: September 22, 2009
• Last Update Posted Date: June 14, 2011
• Study Start Date: October 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 14, 2009)

CFU (Colony Forming Units) [ Time Frame: 4 hours ]

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

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of Salivary Bacteria and Post Brushing
• Official Title: Efficacy of Salivary Bacteria and Post Brushing
• Brief Summary: Research study to compare the effects of brushing with two commercially available toothpastes on salivary bacteria after brushing
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Single (Participant); Primary Purpose: Treatment
• Condition: Salivary Bacteria Levels

Intervention

• Drug: Fluoride
  Whole mouth brushing for 7 days
  Other Name: fluoride toothpaste (Colgate Great Regular Flavor toothpaste)
• Drug: Triclosan/Fluoride
  Brush whole mouth twice daily for 7 days
  Other Name: triclosan/fluoride toothpaste (Colgate Total toothpaste)

Study Arms

• Placebo Comparator: A
  fluoride toothpaste control
  Intervention: Drug: Fluoride
• Active Comparator: B
  triclosan/fluoride toothpaste
  Intervention: Drug: Triclosan/Fluoride

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: August 14, 2009): 22
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: December 2007
• Actual Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)

Eligibility Criteria

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)

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 65 Years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: India

Administrative Information

• NCT Number: NCT00981825
• Other Study ID Numbers: ER0-2007-SAL-01-GX
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: William DeVizio/VP - Clinical Research, Colgate Palmolive
• Study Sponsor: Colgate Palmolive
• Collaborators: Not Provided

Investigators

• Principal Investigator: Neelim Utgikar, DDS

• PRS Account: Colgate Palmolive
• Verification Date: June 2011