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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00643838
First Posted: March 26, 2008
Last Update Posted: January 12, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Air Liquide Santé International
  Purpose
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.

Condition Intervention Phase
Dental Cares Drug: Kalinox 170 bar Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Sedation Faisability by Inhalation of Kalinox 170 Bar During Therapeutic Cares in Primary Care Dental Centers

Resource links provided by NLM:


Further study details as provided by Air Liquide Santé International:

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

Secondary Outcome Measures:
  • Patient's acceptance and doctor's satisfaction [ Time Frame: At the end of dental care ]

Estimated Enrollment: 480
Study Start Date: December 2007
Study Completion Date: July 2008
Primary Completion Date: July 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Year and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00643838


Locations
France
Primary dental care centers
France, France
Sponsors and Collaborators
Air Liquide Santé International
  More Information

Responsible Party: Peter ONODY, MD, Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT00643838     History of Changes
Other Study ID Numbers: EudraCT : 2006-005691-40
First Submitted: March 20, 2008
First Posted: March 26, 2008
Last Update Posted: January 12, 2009
Last Verified: January 2009

Additional relevant MeSH terms:
Nitrous Oxide
Anesthetics, Inhalation
Anesthetics, General
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents