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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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5 September 2016 |
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Main ID: |
NCT02884817 |
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Date of registration:
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22/08/2016 |
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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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Essential Oil+ELA, Plaque and Gingivitis
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Scientific title:
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The Plaque- and Gingivitis Inhibiting Capacity of a Commercially Available Mouthwash Containing Essential Oils and Ethyl Lauroyl Arginate: A Parallel, Split-mouth, Double Blind, Randomized, Placebo-controlled Clinical Study |
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Date of first enrolment:
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September 2015 |
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Target sample size:
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59 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02884817 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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Phase:
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Phase 4
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Countries of recruitment
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Norway
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Key inclusion & exclusion criteria
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Inclusion Criteria:
healthy subjects from both gender snon-smoking aged 20-55yr having at least three of the
following teeth in maxillary right and left quadrant: the canine, 1st bicuspid, 2nd
bicuspid, 1st molar, healthy gingiva and periodontium.
Exclusion Criteria:
pregnancy lactation any chronic diseases clinical signs or symptoms of acute infection in
the oral cavity any prescribed or non-prescription systemic or topical medication except
oral contraceptives clinical parameters judged as unacceptable by the principle
investigator use of systemic antibiotics the last 3 months prior to the start of the study
history of alcohol or drug abuse participation in other clinical studies in the last
4weeks
Age minimum:
20 Years
Age maximum:
55 Years
Gender:
Both
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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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Other: Water
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Drug: Experimental: essential oils and ELA
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Other: Placebo
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Primary Outcome(s)
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Plaque index (Silness & Loe 1964)
[Time Frame: 21 days]
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Secondary Outcome(s)
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The gingival index (GI) (Løe & Silness 1963)
[Time Frame: 21 days]
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Secondary ID(s)
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REK2015/417
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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