Status:
COMPLETED
Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers
Lead Sponsor:
Air Liquide Santé International
Conditions:
Dental Cares
Eligibility:
All Genders
1+ years
Phase:
PHASE3
Brief Summary
A 50% nitrous oxide / 50% oxygen premix is administrated to the patient during the realization of dental cares. This openly clinical trial is done in 36 French primary care dental centers, especially ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2008
Estimated Enrollment :
549 Patients enrolled
Trial Details
Trial ID
NCT00643838
Start Date
December 1 2007
End Date
July 1 2008
Last Update
September 15 2025
Active Locations (1)
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1
Primary dental care centers
Clermont-Ferrand, France