The Clinical Investigation of a Zinc Based Toothpaste in Reducing Plaque and Gingivitis
NCT ID: NCT02243046
Last Updated: 2019-02-25
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
162 participants
INTERVENTIONAL
2014-12-31
2015-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Control toothpaste
1450 ppm Fluoride toothpaste
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.
Experimental toothpaste
1450 ppm sodium fluoride toothpaste with a zinc base
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
1450 ppm sodium fluoride/triclosan toothpaste
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.
Interventions
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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.
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
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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
70 Years
ALL
Yes
Sponsors
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Colgate Palmolive
INDUSTRY
Responsible Party
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Locations
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Spa Dental
Santo Domingo, , Dominican Republic
Countries
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Other Identifiers
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CRO-2014-11-PG-ZNPTCN-ED
Identifier Type: -
Identifier Source: org_study_id
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