Interest of re-Oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares

This study has been terminated.

First Received: March 20, 2008 Last Updated: March 25, 2008 History of Changes

Sponsored by:	Air Liquide Santé International
Information provided by:	Air Liquide Santé International
ClinicalTrials.gov Identifier:	NCT00643786

Purpose

The usefulness of re-oxygenation after inhalation of 50% nitrous oxide and 50% oxygen premix (Kalinox 170 bar) during dental care is studied and the pollution resulting from administration of Kalinox is also investigated.

Condition	Intervention	Phase
Dental Cares Under Kalinox's Inhalation	Drug: Oxygène Drug: Air Médical	Phase III

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of re-Oxygenation and Pollution Control

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:

Measurement of SpO2 [ Time Frame: In continuous ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Analysis of ambient air pollution by nitrous oxide and patient's acceptance [ Time Frame: In continuous ] [ Designated as safety issue: No ]

Enrollment:	128
Study Start Date:	February 2004
Estimated Study Completion Date:	June 2008
Primary Completion Date:	May 2007 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Oxygène	Drug: Oxygène Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
B: Placebo Comparator Air Médical	Drug: Air Médical Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation

Eligibility

Ages Eligible for Study:	1 Year and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

From 1 year old
anxious or phobic patients
very young children requiring selective dental cares
mental deficient patients
ASA 1 or ASA 2 patients

Exclusion Criteria:

ASA 3 or ASA 4 patients
contraindication linked to the experimental product
patients with mental disorder incompatible with the motory test
patients that have received anxiolytic treatment less than 2 hours before the dental care

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643786

Locations

France
UFR Odontologie Equipe d'accueil 3847
Clermont-Ferrand, France, 63000

Sponsors and Collaborators

Air Liquide Santé International

More Information

No publications provided

Responsible Party:	Air Liquide Santé International ( Peter ONODY, MD )
Study ID Numbers:	EudraCT : 031003
Study First Received:	March 20, 2008
Last Updated:	March 25, 2008
ClinicalTrials.gov Identifier:	NCT00643786 History of Changes
Health Authority:	France: Afssaps - French Health Products Safety Agency

Study placed in the following topic categories:

Nitrous Oxide

ClinicalTrials.gov processed this record on May 07, 2009