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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/2010/002 |
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Date of registration:
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12/03/2010 |
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Primary sponsor: |
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Public title:
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A controlled trial of a herbal Ayurvedic toothpaste (Sudantha ®)
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Scientific title:
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A randomized double- blind, placebo- controlled study on the effects of a herbal toothpaste ( Sudantha ®) on gingival, oral hygiene and microbial parameters |
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Date of first enrolment:
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1/4/2010 |
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Target sample size:
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30 participants in each arm |
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Recruitment status: |
Completed |
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URL:
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http://www.slctr.lk/trial_details.asp?reg_id={B5067A82-9DF0-421D-806A-4C99E3342EBE} |
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Study type:
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Interventional |
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Study design:
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Placebo-controlled double-blind trial in healthy volunteers.
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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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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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081 - 2397552 |
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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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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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081 - 2397552 |
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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: Healthy volunteers over 18 years of age with no co-morbidities, with similar plaque and gingival bleeding.
Exclusion criteria: Presence of co-morbidities, current users of herbal toothpaste
Age minimum:
Age maximum:
Gender:
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Health Condition(s) or Problem(s) studied
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Oral and gingival hygiene
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Intervention(s)
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Tooth brushing with placebo or Sudantha toothpaste.
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Primary Outcome(s)
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1.Total salivary bacterial counts (aerobic and anaerobic)
2.Plaque score.
3.Gingival bleeding.
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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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Link Natural Products (Pvt) Ltd, 199, Kew Road, Colombo 02, Sri Lanka
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