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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT02360995 |
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Date of registration:
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06/02/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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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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Scientific title:
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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 |
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Date of first enrolment:
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June 2014 |
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Target sample size:
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129 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02360995 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 4
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Countries of recruitment
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United States
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Contacts
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Name:
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Yimimg Li, DDS, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Loma Linda University |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Dental Plaque
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Gingivitis
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Intervention(s)
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Drug: stannous fluoride toothpaste
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Drug: Fluoride Mouthwash
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Drug: Triclosan/fluoride toothpaste
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Drug: cetylpyridinium chloride Mouthwash
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Drug: fluoride toothpaste
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Primary Outcome(s)
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Gingivitis Scores
[Time Frame: 4 weeks]
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Gingivitis Scores
[Time Frame: Baseline]
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Dental Plaque Scores
[Time Frame: 4 weeks]
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Dental Plaque Scores
[Time Frame: 6 weeks]
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Gingivitis Scores
[Time Frame: 6 weeks]
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Dental Plaque Scores
[Time Frame: Baseline]
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Secondary ID(s)
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CRO-2014-06-PLAGIN-CT-YPZ
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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