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Main
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Note: This record shows only the 20 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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SLCTR |
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Last refreshed on:
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27 April 2013 |
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Main ID: |
SLCTR/2011/007 |
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Date of registration:
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03/06/2011 |
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Primary sponsor: |
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Public title:
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Effects of an eugenol containg toothpaste Clogard on gum disease
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Scientific title:
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Effects of an eugenol containing toothpaste Clogard ® after three months use in patients with chronic gingivitis |
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Date of first enrolment:
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20/6/2011 |
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Target sample size:
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30 participants in each arm |
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Recruitment status: |
Pending |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={229BB1DF-2AA4-4763-8B21-80CAEAE9F170} |
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Study type:
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Interventional |
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Study design:
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Randomised placebo-controlled double blind clinical trial
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Countries of recruitment
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Sri Lanka
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Contacts
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Name:
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Prof. Sunethra Rajapakse
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Address:
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Faculty of Dental Science, University of Peradeniya
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Telephone:
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0812397552 |
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Email:
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sunethraraj@pdn.ac.lk |
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Affiliation:
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Professor in Periodontology |
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Name:
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Prof. Sunethra Rajapakse
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Address:
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Faculty of Dental Sciences, University of Peradeniya
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Telephone:
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0812397552 |
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Email:
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sunethraraj@pdn.ac.lk |
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Affiliation:
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Professor in Periodontology |
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Key inclusion & exclusion criteria
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Inclusion criteria: Patients over 18 years of age with no co-morbidities
Exclusion criteria: presence of co-morbidities, current users of eugenol containing toothpastes or herbal toothpastes
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Chronic gingivitis
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Intervention(s)
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Toothbrushing with a placebo or Clogard ® toothpaste for three months
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Primary Outcome(s)
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Gingival bleeding on probing, probing pocket depth, plaque score, aerobic and anaerobic salivary bacterial counts at 4, 8 and 12 weeks
Gingival crevicular fluid volume in relation gingival pocket of two selected teeth baseline 4 weeks, 8 weeks and 12 weeks
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Secondary ID(s)
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Nil known
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Source(s) of Monetary Support
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Hemas Manufacturing Pvt Ltd, Sri Lanka
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