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Trial record 5 of 296 for:    Sodium Fluoride OR Duraphat

Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste (CP_Total)

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ClinicalTrials.gov Identifier: NCT04033575
Recruitment Status : Completed
First Posted : July 26, 2019
Last Update Posted : July 26, 2019
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Tracking Information
First Submitted Date  ICMJE July 24, 2019
First Posted Date  ICMJE July 26, 2019
Last Update Posted Date July 26, 2019
Actual Study Start Date  ICMJE March 6, 2019
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 24, 2019)
  • 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: 3 months ]
    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)
  • Dental Plaque Score [ 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 Score [ Time Frame: 3 months ]
    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)
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
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 of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste
Official Title  ICMJE Clinical Investigation of a Toothpaste Containing Stannous Fluoride as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Three Month Study
Brief Summary The objective of this study is to evaluate the clinical efficacy of a toothpaste containing stannous fluoride as compared to Colgate Fluoride Toothpaste in reducing plaque and gingivitis - a three- month study.
Detailed Description This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
This was a 6-month, randomized, single-center, parallel group, double-blinded, clinical research study to assess the clinical efficacy of two toothpastes containing stannous fluoride (SnHW and CPH) as compared to Regular Fluoride Toothpaste on the reduction of established dental plaque and gingivitis in adults.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:

CRO-2019-03-PG-SNF-FL-BGS Product XXX Brush your teeth twice daily (morning and evening) for two (2) minutes each time.

Cover the length of the toothbrush bristles with the toothpaste. For investigational use only by the study participant. Not for sale. For Adult Use Only. Keep out of reach of children under 6 years.

In case of emergency or for further information contact:

Primary Purpose: Treatment
Condition  ICMJE Gingivitis
Intervention  ICMJE
  • Drug: Colgate Total SF
    1100 ppm F Colgate Total Clean Mint White Paste Toothpaste is a test treatment
    Other Name: Stannous Fluoride
  • Drug: Colgate Cavity Protection toothpaste
    0.76% monofluorophosphate (1000 ppm MFP), Colgate Cavity Protection toothpaste is a control treatment.
    Other Name: CDC
Study Arms  ICMJE
  • Sham Comparator: Fluoride Control
    Colgate Cavity Protection 0.76% as Na MFP Toothpaste
    Intervention: Drug: Colgate Cavity Protection toothpaste
  • Active Comparator: Colgate Total SF
    Colgate Total Clean Mint White Paste 1100 ppm F Toothpaste
    Intervention: Drug: Colgate Total SF
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: July 24, 2019)
88
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE July 1, 2019
Actual Primary Completion Date June 6, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Subjects, ages 18-70, inclusive. Availability for the six-month duration ofthe clinical research study. Good general health. Minimum of 20 uncrowned permanent natural teeth (excluding third molars). Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.

Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).

Signed Informed Consent Form.

Exclusion Criteria:

Presence of partial denture. Presence of partial removable dentures. Tumor(s) of the soft or hard tissues of the oral cavity. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).

Five or more carious lesions requiring immediate restorative treatment. Antibiotic use any time during the one month prior to entry into the study. Participation in any other clinical study or test panel within the one month prior to entry into the study.

Dental prophylaxis during the past two weeks prior to baseline examinations. History of allergies to oral care/personal care consumer products or their ingredients.

On any prescription medicines that might interfere with the study outcome. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.

History of alcohol or drug abuse. 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 NCT04033575
Other Study ID Numbers  ICMJE CRO-2019-03-PG-SNF-FL-BGS
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Colgate Palmolive
Study Sponsor  ICMJE Colgate Palmolive
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Yun Po Zhang, Doctoral Colgate Palmolive
PRS Account Colgate Palmolive
Verification Date July 2019

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