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The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US

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ClinicalTrials.gov Identifier: NCT02360995
Recruitment Status : Completed
First Posted : February 11, 2015
Results First Posted : March 30, 2016
Last Update Posted : March 30, 2016
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE February 6, 2015
First Posted Date  ICMJE February 11, 2015
Results First Submitted Date  ICMJE February 1, 2016
Results First Posted Date  ICMJE March 30, 2016
Last Update Posted Date March 30, 2016
Study Start Date  ICMJE June 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 6, 2015)
  • Dental Plaque Scores [ Time Frame: Baseline ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
  • Dental Plaque Scores [ Time Frame: 4 weeks ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
  • Dental Plaque Scores [ Time Frame: 6 weeks ]
    Dental Plaque (Quigley-Hein, Turesky Modification Index) Units on a scale 0 to 5 (0 = no plaque, 1 = separate flecks of plaque on the tooth, 2 = a thin continuous band of plaque, 3 = a band of plaque up to one-third of the tooth, 4 = plaque covering up to two thirds of the of the tooth, 5 = plaque covering two-thirds or more of the crown of the tooth)
  • Gingivitis Scores [ Time Frame: Baseline ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
  • Gingivitis Scores [ Time Frame: 4 weeks ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
  • Gingivitis Scores [ Time Frame: 6 weeks ]
    Gingivitis scale (Loe & Silness Gingival Index) Units on a scale 0 to 3 (0 = no inflammation, 1 = Mild inflammation-slight change in color and little change in texture 2 = Moderate inflammation-moderate glazing, redness, edema and hypertrophy. Tendency to bleed upon probing. 3 = Severe inflammation-marked redness and hypertrophy. Tendency to spontaneous bleeding)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT02360995 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 The Clinical Investigation of Toothpaste as Compared to Toothpaste and Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Official Title  ICMJE The Clinical Investigation of Colgate Total Toothpaste as Compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in Reducing Plaque and Gingivitis: A Six-week Clinical Study in the US
Brief Summary The objective of this clinical research study is to evaluate clinical efficacy of Colgate Total Toothpaste as compared to Crest Pro-Health Toothpaste and Crest Pro-Health Mouthwash, and Crest Cavity Protection Toothpaste and Crest Fluoride Mouthwash in reducing gingivitis and dental plaque in adults in a six-week clinical study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Dental Plaque
  • Gingivitis
Intervention  ICMJE
  • Drug: Triclosan/fluoride toothpaste
    Brush whole mouth with Total toothpaste (sold in the US), using a Total 360 toothbrush, 2 times/day for 6 weeks (study duration).
    Other Name: Total toothpaste
  • Drug: stannous fluoride toothpaste
    Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
    Other Name: Crest Pro-Health toothpaste
  • Drug: fluoride toothpaste
    Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 weeks (study duration).
    Other Name: Crest Cavity Protection toothpaste
  • Drug: Fluoride Mouthwash
    Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest fluoride Mouthrinse for 30 seconds each time.
    Other Name: Crest Pro-Health For Me Breezy Mint mouthwash
  • Drug: cetylpyridinium chloride Mouthwash
    Immediately after each toothbrushing rinse whole mouth with 20 ml of Crest Pro-Health Mouthrinse for 30 seconds each time.
    Other Name: Crest Pro-Health Multi-Protection mouthwash
Study Arms  ICMJE
  • Active Comparator: Total Toothpaste
    Triclosan/fluoride toothpaste
    Intervention: Drug: Triclosan/fluoride toothpaste
  • Active Comparator: Toothpaste + Mouthwash
    Stannous fluoride toothpaste & cetylpyridinium chloride Mouthwash
    Interventions:
    • Drug: stannous fluoride toothpaste
    • Drug: cetylpyridinium chloride Mouthwash
  • Placebo Comparator: Control group
    fluoride toothpaste +fluoride mouthwash
    Interventions:
    • Drug: fluoride toothpaste
    • Drug: Fluoride Mouthwash
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: February 6, 2015)
129
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Subjects, ages 18-70, inclusive.
  2. Availability for the six-week duration of the clinical research study.
  3. Good general health.
  4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
  5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
  6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
  7. Signed Informed Consent Form

Exclusion Criteria:

  1. Presence of orthodontic bands.
  2. Presence of partial removable dentures.
  3. Tumor(s) of the soft or hard tissues of the oral cavity.
  4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
  5. Five or more carious lesions requiring immediate restorative treatment.
  6. Antibiotic use any time during the one month prior to entry into the study.
  7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
  8. Dental prophylaxis during the past two weeks prior to baseline examinations.
  9. History of allergies to oral care/personal care consumer products or their ingredients.
  10. On any prescription medicines that might interfere with the study outcome.
  11. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
  12. History of alcohol or drug abuse.
  13. Pregnant or lactating subjects.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 70 Years   (Adult, Older 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 NCT02360995
Other Study ID Numbers  ICMJE CRO-2014-06-PLAGIN-CT-YPZ
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
Principal Investigator: Yimimg Li, DDS, PhD Loma Linda University
PRS Account Colgate Palmolive
Verification Date May 2014

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