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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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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT00963898 |
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Date of registration:
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20/08/2009 |
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Primary sponsor: |
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Public title:
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Accurate Controlled Dental Sedation
ACDS |
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Scientific title:
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The Clinical Efficacy of the Combination Target Controlled Infusion With Bispectral Index Monitor in Propofol Sedation for Dental Patients With Mental Retardation |
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Date of first enrolment:
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April 2007 |
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Target sample size:
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40 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00963898 |
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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: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Supportive Care
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Countries of recruitment
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Japan
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Contacts
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Name:
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Hitoshi Higuchi, D.D.S., Ph.D |
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Address:
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Telephone:
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Email:
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Affiliation:
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Okayama University |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
1. Participants aged 16 or over,
2. American Society of Anesthesiologists (ASA) physical status 1 or 2
3. The treatments of dental caries, endodontics, periodontics and prosthesis were planed
4. Participants had moderate or severe Mental Retardation, and were not completely
cooperated with dental treatment
Exclusion Criteria:
1. Patients could communicate and cooperate with dental treatment, but used dental
sedation for decrease of the anxiety and the fear about dental treatment or another
reasons,
2. Patients needed premedication
3. Patients had uncontrolled or sever medical condition
Age minimum:
16 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Mental Retardation
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Intervention(s)
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Device: Target controlled infusion(TCI), Bispectral index(BIS)
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Primary Outcome(s)
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The dose of anesthesia agent
[Time Frame: 1 day]
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The recovery times of eyelash reflex and eye opening
[Time Frame: 1 day]
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The time to going home
[Time Frame: 1 day]
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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