Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares

Phase 3

Terminated

• Conditions: Dental Cares Under Kalinox's Inhalation
• Interventions: Drug: Oxygène; Drug: Air Médical

• Registration Number: NCT00643786
• Lead Sponsor: Air Liquide Santé International

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-02
• Primary Completion: 2007-05
• Study First Submitted: 2008-03-20
• Study First Submitted QC: 2008-03-25
• Study First Posted: 2008-03-26
• Study Completion: 2008-06
• Status Verified: 2014-06
• Last Update Submitted: 2014-06-23
• Last Update Posted: 2014-06-24

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 128

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
A	Oxygène	Oxygène
B	Air Médical	Air Médical

Primary Outcome Measures

Name	Time	Method
Measurement of SpO2	In continuous

Secondary Outcome Measures

Name	Time	Method
Analysis of ambient air pollution by nitrous oxide and patient's acceptance	In continuous

Trial Locations

Locations (1)

UFR Odontologie Equipe d'accueil 3847; 🇫🇷 Clermont-Ferrand, France