Use of 50% Nitrous Oxide / 50% Oxygen Premix in Primary Care Dental Centers

This study has been completed.

First Received: March 20, 2008 Last Updated: January 9, 2009 History of Changes

Sponsored by:	Air Liquide Santé International
Information provided by:	Air Liquide Santé International
ClinicalTrials.gov Identifier:	NCT00643838

Purpose

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 on anxious and phobic patients but also on infants or mental deficient adults. At least 480 patients will be included in this clinical protocol.

Condition	Intervention	Phase
Dental Cares	Drug: Kalinox 170 bar	Phase III

MedlinePlus related topics: Dental Health

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

Further study details as provided by Air Liquide Santé International:

Primary Outcome Measures:

Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS) [ Time Frame: At the end of the dental care ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Patient's acceptance and doctor's satisfaction [ Time Frame: At the end of dental care ] [ Designated as safety issue: No ]

Estimated Enrollment:	480
Study Start Date:	December 2007
Study Completion Date:	July 2008
Primary Completion Date:	July 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
A: Experimental Misture of 50% nitrous oxide and 50% oxygen	Drug: Kalinox 170 bar Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour

Eligibility

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643838

Locations

France
Primary dental care centers
France, France

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 : 2006-005691-40
Study First Received:	March 20, 2008
Last Updated:	January 9, 2009
ClinicalTrials.gov Identifier:	NCT00643838 History of Changes
Health Authority:	France : Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

Study placed in the following topic categories:

Nitrous Oxide

ClinicalTrials.gov processed this record on May 07, 2009