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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: |
NCT00926328 |
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Date of registration:
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26/09/2008 |
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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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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis
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Scientific title:
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Comparative Efficacy of a Toothpaste That Reduces Plaque and Gingivitis |
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Date of first enrolment:
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June 2007 |
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Target sample size:
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120 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00926328 |
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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 3
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Countries of recruitment
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Spain
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Contacts
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Name:
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Augusto E Boneta, DDS |
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Address:
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Telephone:
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Email:
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Affiliation:
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Dental Research Associates |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Availability for the six-month duration of the 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 orthodontic bands.
- 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.
- Use of antibiotics 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.
- Pregnant women or women who are breast feeding.
- Receive a dental prophylaxis in the past two weeks prior to baseline examinations.
- History of allergic to personal care/consumer products or their ingredients.
- Taking any prescription medicines. That might interfere with the study outcome.
- Individuals with an existing medical condition which prohibits them from not eating or
drinking for periods up to 4 hours.
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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Gingivitis
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Intervention(s)
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Drug: Triclosan, fluoride
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Drug: Fluoride
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Primary Outcome(s)
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Plaque Index
[Time Frame: 6 Months]
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Gingivitis Index
[Time Frame: 6 months]
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Secondary ID(s)
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CRO-0507-PL-SP-CT-BS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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