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Trial record 79 of 292 for:    Sodium Fluoride OR Duraphat

The Clinical Investigation of a New Toothpaste Containing Stannous Fluoride as Compared to a Commercially Available Fluoride Toothpaste in Reducing Plaque and Gingivitis

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ClinicalTrials.gov Identifier: NCT03852056
Recruitment Status : Completed
First Posted : February 22, 2019
Last Update Posted : February 22, 2019
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
The objective of this study is to evaluate the clinical efficacy of a new toothpaste containing stannous fluoride (SnF) as compared to Colgate Fluoride Toothpaste in reducing gingivitis and dental plaque.

Condition or disease Intervention/treatment Phase
Dental Plaque Gingivitis Drug: MFP Fluoride toothpaste Drug: Stannous fluoride toothpaste Phase 3

Detailed Description:

This is a 6 month, take home, tooth brushing research study to evaluate a new toothpaste.

Qualified subjects will be enrolled and randomized to either one of the two study groups based on their initial Plaque and Gingivitis scores. Subjects will be instructed to use the products according to the instructions provided. Subjects will return to the dental office for evaluation after three and six months of product use. All subjects will be followed for adverse events throughout the study.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 98 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Tooth brushing study. Subjects brush their whole mouth 2x/day for 1 minute each time. The study duration is 6 months
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description: All clinical product will be in a plain white toothpaste tube or over wrapped with white laminate material to conceal any product identity. All study treatments will have a clinical label attached that contains study information and a unique product code.
Primary Purpose: Treatment
Official Title: The Clinical Investigation of a New Toothpaste Containing SnF as Compared to Colgate Fluoride Toothpaste in Reducing Plaque and Gingivitis - a Six-month Study in China
Actual Study Start Date : May 25, 2017
Actual Primary Completion Date : December 7, 2017
Actual Study Completion Date : December 7, 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: MFP Fluoride toothpaste
Commercially available, monofluorophosphate (MFP) toothpaste. Fluoride level is 0.76%
Drug: MFP Fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,
Other Name: Colgate Great Regular Flavor toothpaste

Experimental: Stannous Fluoride Toothpaste
New toothpaste containing 0.454% stannous fluoride.
Drug: Stannous fluoride toothpaste
Whole mouth brushing with a toothpaste, 2 times/day for 1 minute each time for the duration of the study,




Primary Outcome Measures :
  1. Dental Plaque Scores [ Time Frame: Baseline ]
    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)

  2. Dental Plaque Scores [ Time Frame: 3 month ]
    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)

  3. Dental Plaque Scores [ Time Frame: 6 month ]
    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)

  4. Gingivitis Scores [ Time Frame: Baseline ]
    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)

  5. Gingivitis Scores [ Time Frame: 3 months ]
    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)

  6. Gingivitis Scores [ Time Frame: 6 months ]
    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)



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Subjects, ages 18-70, inclusive.
  2. Availability for the six-month 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 period 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 that prohibits eating or drinking for periods up to 4 hours.
  12. History of alcohol or drug abuse.
  13. Self-reported pregnant or lactating subjects.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03852056


Locations
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China, Sichuan
West China Dental Institute of Chengdu
Chengdu, Sichuan, China, 610041
Sponsors and Collaborators
Colgate Palmolive

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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT03852056     History of Changes
Other Study ID Numbers: CRO-2017-02-GIN-SNDZ-YPZ
First Posted: February 22, 2019    Key Record Dates
Last Update Posted: February 22, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Listerine
Fluorides
Tin Fluorides
Sodium Fluoride
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Cariostatic Agents
Protective Agents
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents