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

Dental Cares Under Kalinox's Inhalation Clinical Trial

Official title:

Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00643786
• Other study ID #: EudraCT : 031003
• Status: Terminated
• Phase: Phase 3
• First received: March 20, 2008
• Last updated: June 23, 2014
• Start date: February 2004
• Est. completion date: June 2008

Study information

• Verified date: June 2014
• Source: Air Liquide Santé International
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 128
• Est. completion date: June 2008
• Est. primary completion date: May 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 1 Year and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Cares Under Kalinox's Inhalation
• Respiratory Aspiration

Intervention

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
• 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

Locations

Country	Name	City	State
France	UFR Odontologie Equipe d'accueil 3847	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
Air Liquide Santé International

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Measurement of SpO2		In continuous	No
Secondary	Analysis of ambient air pollution by nitrous oxide and patient's acceptance		In continuous	No