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

September 9, 2025 updated by: Air Liquide Santé International

Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

549

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
        • Primary dental care centers

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

1 year and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: A
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Pain measurement by using Visual Analog Scale (VAS) and Face Pain Scale (FPS)
Time Frame: At the end of the dental care
At the end of the dental care

Secondary Outcome Measures

Outcome Measure
Time Frame
Patient's acceptance and doctor's satisfaction
Time Frame: At the end of dental care
At the end of dental care

Collaborators and Investigators

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

Sponsor

Air Liquide Santé International

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

December 1, 2007

Primary Completion (Actual)

July 1, 2008

Study Completion (Actual)

July 1, 2008

Study Registration Dates

First Submitted

March 20, 2008

First Submitted That Met QC Criteria

March 20, 2008

First Posted (Estimated)

March 26, 2008

Study Record Updates

Last Update Posted (Estimated)

September 15, 2025

Last Update Submitted That Met QC Criteria

September 9, 2025

Last Verified

January 1, 2009

More Information

Terms related to this study

Other Study ID Numbers

  • EudraCT : 2006-005691-40

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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