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Trial record 5 of 43 for:    FLUORIDE ION AND TRICLOSAN

Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

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ClinicalTrials.gov Identifier: NCT02194621
Recruitment Status : Completed
First Posted : July 18, 2014
Results First Posted : April 15, 2016
Last Update Posted : April 15, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE July 15, 2014
First Posted Date  ICMJE July 18, 2014
Results First Submitted Date  ICMJE February 1, 2016
Results First Posted Date  ICMJE April 15, 2016
Last Update Posted Date April 15, 2016
Study Start Date  ICMJE January 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 30, 2016)
  • Anaerobic Bacteria [ Time Frame: Baseline ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
  • Anaerobic Bacteria [ Time Frame: 12 hours ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
  • Malodor Bacteria (Breath Odor Causing Bacteria) [ Time Frame: Baseline ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
  • Malodor Bacteria (Breath Odor Causing Bacteria) [ Time Frame: 12 hours ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Original Primary Outcome Measures  ICMJE
 (submitted: July 16, 2014)
  • Anaerobic Bacteria [ Time Frame: 12 hours ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine total levels of anaerobic bacteria CFU - colony forming units.
  • Malodor Bacteria (Breath Odor Causing Bacteria) [ Time Frame: 12 hours ]
    Subjects brush their teeth with assigned toothpaste 2x/day for 13 days. On clinic visit day, subjects brush their teeth and return 12 hours later for clinical evaluation. Samples of dental plaque at the gumline will be collected for microbiological analysis to determine levels of mouth odor causing bacteria CFU - colony forming units.
Change History Complete list of historical versions of study NCT02194621 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria
Official Title  ICMJE A Randomized, Single Center, Three Cell, Double Blind and Parallel Groups Clinical Study Conducted in Newark, NJ to Evaluate the Antibacterial Effects of Two Toothpastes Containing 0.3% Triclosan/2% Copolymer/0.243% Sodium Fluoride in a Silica Base as Compared to a Control Regular Fluoride Toothpaste on Oral Bacteria 12 Hours After 13 Days Product Use.
Brief Summary The primary objective was to evaluate the antibacterial effects of two toothpastes containing 0.3% triclosan, 2% copolymer and 0.234% sodium fluoride in a silica base as compared to a control regular fluoride toothpaste on anaerobic and malodor bacteria 12 hours after 13 days of product use. A secondary objective was to demonstrate that a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a flavor with odor-masking ingredients in silica base (Colgate Total Toothpaste-Flavor Option 1) provides a level of antibacterial efficacy that is "equivalent" to a toothpaste containing 0.3% triclosan, 2% copolymer, 0.234% sodium fluoride and a regular flavor in silica base (Colgate Total Toothpaste-Flavor Option 2) after 13 days of product use.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Oral Bacteria Levels in the Mouth
Intervention  ICMJE
  • Drug: Total Flavor option 1
    Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM complex 1 ingredient -Total Flavor Option 1
    Other Name: Total toothpaste
  • Drug: Total Flavor option 2
    Total toothpaste containing triclosan/copolymer/sodium fluoride and new OM complex 2 ingredient. Total Flavor option 2
    Other Name: Total toothpaste
  • Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
    Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
    Other Name: Crest Anti-Cavity toothpaste
Study Arms  ICMJE
  • Experimental: Total Flavor Option 1
    Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1
    Intervention: Drug: Total Flavor option 1
  • Experimental: Total Flavor Option 2
    Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2
    Intervention: Drug: Total Flavor option 2
  • Placebo Comparator: Crest Toothpaste
    Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
    Intervention: Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 30, 2016)
128
Original Actual Enrollment  ICMJE
 (submitted: July 16, 2014)
107
Actual Study Completion Date  ICMJE March 2014
Actual Primary Completion Date March 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Males and females in good general health aged 18 to 70 years.
  2. 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.
  3. A minimum of 20 natural teeth with facial and lingual scorable surfaces.
  4. Adequate oral hygiene and no signs of oral neglect.
  5. Good periodontal health. Enrolled subjects will have no more than five periodontal pockets of 5 mm.
  6. Subjects with gingival index greater than or equal to 1.0 (Loe-Silness Index) and plaque index greater than or equal to 1.5 (Turesky modification of Quigley-Hein Index) will be enrolled.

Exclusion Criteria:

  1. 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.
  2. Teeth that are grossly carious, fully crowned or extensively restored on facial and/or lingual surfaces, orthodontically banded, abutments, or third molars
  3. History of diabetes or hepatic or renal disease, or other serious medical conditions or transmittable diseases, e.g. heart disease or AIDS.
  4. History of rheumatic fever, heart murmur, mitral valve prolapse or other conditions requiring prophylactic antibiotic coverage prior to invasive dental procedures.
  5. Subjects on antibiotic, anti-inflammatory or anticoagulant therapy during the month preceding the baseline exam.
  6. Significant oral soft tissue pathology, systemically related gingival enlargement, severe gingivitis (based on a visual examinations).
  7. History of active severe periodontal disease with bleeding gums and loose teeth.
  8. 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.
  9. Fixed or removable orthodontic appliance or removable partial dentures.
  10. 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.
  11. Self reported pregnancy or lactation.
  12. History or current use of objects to pierce the lips or tongue.
  13. Subjects known to be an alcoholic, or a recovering alcoholic.
  14. History or current use of recreational drugs.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 22 Years to 58 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02194621
Other Study ID Numbers  ICMJE CRO-1113-BACT-PS-NJ
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Colgate Palmolive
Study Sponsor  ICMJE Colgate Palmolive
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Colgate Palmolive
Verification Date July 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP