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Trial record 23 of 251 for:    sodium fluoride

Clinical Investigation to Examine Toothpaste Effect on Oral Bacteria

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive
ClinicalTrials.gov Identifier:
NCT02194621
First received: July 15, 2014
Last updated: March 30, 2016
Last verified: July 2014
  Purpose
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.

Condition Intervention Phase
Oral Bacteria Levels in the Mouth
Drug: Total Flavor option 1
Drug: Total Flavor option 2
Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:


Further study details as provided by Colgate Palmolive:

Primary Outcome Measures:
  • Anaerobic Bacteria [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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.


Enrollment: 128
Study Start Date: January 2014
Study Completion Date: March 2014
Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Total Flavor Option 1
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 1 ingredient - Total Flavor Option 1
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
Experimental: Total Flavor Option 2
Total toothpaste containing triclosan/copolymer/sodium fluoride with new OM (oral malodor) complex 2 ingredient. Total Flavor Option 2
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
Placebo Comparator: Crest Toothpaste
Placebo toothpaste: Crest Cavity Protection toothpaste (currently marketed)
Drug: Placebo toothpaste: Crest Cavity Protection toothpaste
Placebo toothpaste: Crest Cavity Protection toothpaste w/sodium fluoride (currently marketed)
Other Name: Crest Anti-Cavity toothpaste

  Eligibility

Ages Eligible for Study:   22 Years to 58 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02194621

Locations
United States, New Jersey
Rutgers School of Dental Medicine
Newark, New Jersey, United States, 07107
Sponsors and Collaborators
Colgate Palmolive
  More Information

Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02194621     History of Changes
Other Study ID Numbers: CRO-1113-BACT-PS-NJ 
Study First Received: July 15, 2014
Results First Received: February 1, 2016
Last Updated: March 30, 2016
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Fluorides
Sodium Fluoride
Listerine
Triclosan
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents

ClinicalTrials.gov processed this record on September 26, 2016