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

This study has been completed.
Sponsor:
Information provided by:
Air Liquide Santé International
ClinicalTrials.gov Identifier:
NCT00643838
First received: March 20, 2008
Last updated: January 9, 2009
Last verified: January 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient's acceptance and doctor's satisfaction [ Time Frame: At the end of dental care ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   1 Year and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00643838

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

No publications provided

Responsible Party: Peter ONODY, MD, Air Liquide Santé International
ClinicalTrials.gov Identifier: NCT00643838     History of Changes
Other Study ID Numbers: EudraCT : 2006-005691-40
Study First Received: March 20, 2008
Last Updated: January 9, 2009
Health Authority: France : Agence Française de Sécurité Sanitaire des Produits de Santé (AFSSAPS)

ClinicalTrials.gov processed this record on September 18, 2014