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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 February 2015 |
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Main ID: |
NCT00643838 |
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Date of registration:
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20/03/2008 |
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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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Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers
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Scientific title:
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Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers |
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Date of first enrolment:
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December 2007 |
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Target sample size:
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480 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT00643838 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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France
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- anxious and/or phobic patients having a vomiting reflex
- very young children requiring selective dental cares
- mental deficient patient
- patient having specific phobia linked to the dental care to be done
- patient from 1 year old
- ASA 1 or ASA 2 patient
- existing of efficient contraception
Exclusion Criteria:
- ASA 3 or ASA 4 patient
- patient already treated without using Kalinox's sedation
- patient already included in this protocol in a delay lower than 7 days
- contraindication linked to the experimental product
- Kalinox's inhalation duration higher than 1 hour
- pregnant or breast-feeding women
Age minimum:
1 Year
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Dental Cares
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Intervention(s)
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Drug: Kalinox 170 bar
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Primary Outcome(s)
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Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
[Time Frame: At the end of the dental care]
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Secondary Outcome(s)
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Patient's acceptance and doctor's satisfaction
[Time Frame: At the end of dental care]
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Secondary ID(s)
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EudraCT : 2006-005691-40
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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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