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

Primary Purpose

Dental Cares Under Kalinox's Inhalation

Status
Terminated
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Oxygène
Air Médical
Sponsored by
Air Liquide Santé International
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Cares Under Kalinox's Inhalation

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UFR Odontologie Equipe d'accueil 3847

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

A

B

Arm Description

Oxygène

Air Médical

Outcomes

Primary Outcome Measures

Measurement of SpO2

Secondary Outcome Measures

Analysis of ambient air pollution by nitrous oxide and patient's acceptance

Full Information

First Posted
March 20, 2008
Last Updated
June 23, 2014
Sponsor
Air Liquide Santé International
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1. Study Identification

Unique Protocol Identification Number
NCT00643786
Brief Title
Interest of Re-oxygenation After Inhalation of 50% Nitrous Oxide / 50% Oxygen Premix in Dental Cares
Official Title
Validation of a Kalinox's Administration Protocol for Dental Cares : Interest of Re-oxygenation and Pollution Control
Study Type
Interventional

2. Study Status

Record Verification Date
June 2014
Overall Recruitment Status
Terminated
Study Start Date
February 2004 (undefined)
Primary Completion Date
May 2007 (Actual)
Study Completion Date
June 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Air Liquide Santé International

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Cares Under Kalinox's Inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
128 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A
Arm Type
Experimental
Arm Description
Oxygène
Arm Title
B
Arm Type
Placebo Comparator
Arm Description
Air Médical
Intervention Type
Drug
Intervention Name(s)
Oxygène
Intervention Description
Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
Intervention Type
Drug
Intervention Name(s)
Air Médical
Intervention Description
Flow of gas administrated to the patient between 4 and 15 litre/min during 5 minutes after the end of Kalinox's inhalation
Primary Outcome Measure Information:
Title
Measurement of SpO2
Time Frame
In continuous
Secondary Outcome Measure Information:
Title
Analysis of ambient air pollution by nitrous oxide and patient's acceptance
Time Frame
In continuous

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
UFR Odontologie Equipe d'accueil 3847
City
Clermont-Ferrand
ZIP/Postal Code
63000
Country
France

12. IPD Sharing Statement

Learn more about this trial

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

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