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The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis

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ClinicalTrials.gov Identifier: NCT02243046
Recruitment Status : Completed
First Posted : September 17, 2014
Results First Posted : May 4, 2016
Last Update Posted : February 25, 2019
Sponsor:
Information provided by (Responsible Party):
Colgate Palmolive

Brief Summary:
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

Condition or disease Intervention/treatment Phase
Dental Plaque and Gingivitis Drug: Control toothpaste Drug: Experimental toothpaste Drug: Active Comparator Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Clinical Investigation of a Zinc Based Toothpaste as Compared to a Triclosan Based Toothpaste and Colgate Fluoride Toothpaste in Reducing Established Plaque and Gingivitis - a Six-month Study.
Study Start Date : December 2014
Actual Primary Completion Date : May 2015
Actual Study Completion Date : May 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Fluoride

Arm Intervention/treatment
Placebo Comparator: Control toothpaste
1450 ppm Fluoride toothpaste
Drug: Control toothpaste
1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Other Name: Max Fresh toothpaste

Experimental: Experimental toothpaste
1450 ppm sodium fluoride toothpaste with a zinc base
Drug: Experimental toothpaste
1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Active Comparator: Active comparator
1450 ppm sodium fluoride/triclosan toothpaste
Drug: Active Comparator
1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.
Other Name: Total toothpaste




Primary Outcome Measures :
  1. 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)

  2. Gingivitis Scores [ Time Frame: 3 months (from 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)

  3. Gingivitis Scores [ Time Frame: 6 months (from 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)

  4. 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)

  5. Dental Plaque Scores [ Time Frame: 3 months (from 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)

  6. Dental Plaque Scores [ Time Frame: 6 months (from 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)



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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. 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): NCT02243046


Locations
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Dominican Republic
Spa Dental
Santo Domingo, Dominican Republic
Sponsors and Collaborators
Colgate Palmolive

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Responsible Party: Colgate Palmolive
ClinicalTrials.gov Identifier: NCT02243046     History of Changes
Other Study ID Numbers: CRO-2014-11-PG-ZNPTCN-ED
First Posted: September 17, 2014    Key Record Dates
Results First Posted: May 4, 2016
Last Update Posted: February 25, 2019
Last Verified: July 2015
Additional relevant MeSH terms:
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Listerine
Fluorides
Sodium Fluoride
Gingivitis
Dental Plaque
Gingival Diseases
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases
Dental Deposits
Tooth Diseases
Triclosan
Physiological Effects of Drugs
Cariostatic Agents
Protective Agents
Anti-Infective Agents, Local
Anti-Infective Agents
Fatty Acid Synthesis Inhibitors
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents