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

Overview

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.

Full Title of Study: “Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: July 2008

Interventions

  • Drug: Kalinox 170 bar
    • Flow of gas administrated to the patient between 4 and 15 litre/min and less than 1 hour

Arms, Groups and Cohorts

  • Experimental: A
    • Misture of 50% nitrous oxide and 50% oxygen

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Patient’s acceptance and doctor’s satisfaction
    • Time Frame: At the end of dental care

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 1 Year

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Air Liquide Santé International
  • Provider of Information About this Clinical Study
    • Peter ONODY, MD, Air Liquide Santé International

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.