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

June 23, 2014 updated by: Air Liquide Santé International

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

128

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

5 months and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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
Placebo Comparator: B
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Measurement of SpO2
Time Frame: In continuous
In continuous

Secondary Outcome Measures

Outcome Measure
Time Frame
Analysis of ambient air pollution by nitrous oxide and patient's acceptance
Time Frame: In continuous
In continuous

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Air Liquide Santé International

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2004

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

June 1, 2008

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 25, 2008

First Posted (Estimate)

March 26, 2008

Study Record Updates

Last Update Posted (Estimate)

June 24, 2014

Last Update Submitted That Met QC Criteria

June 23, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EudraCT : 031003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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