Text Size

Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Aarhus
ClinicalTrials.gov Identifier:
NCT01022294
First received: November 27, 2009
Last updated: January 30, 2012
Last verified: January 2012
History of Changes
  Purpose

To assess the analgetic effect of nitrousoxide-oxygen inhalation on pain perception in 12-15 years old children from 1) the dental pulp; 2) the masseter muscle; 3) the skin on the upper lip


Condition Intervention
Dental Pain
Muscle Sensitivity to Pressure
Skin Sensitivity to Electric Stimulation
 Drug: Nitrousoxide-oxygen and atmospheric air
Drug: Atmospheric air; nitrousoxide-oxygen

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Aarhus:

Primary Outcome Measures:
  • Dental pain (pulp) threshold [ Time Frame: During and after inhalation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Muscle sensitivity to pressure [ Time Frame: During and after inhalation ] [ Designated as safety issue: No ]
  • Skin sensitivity ot electric stimulation [ Time Frame: During and after inhalation ] [ Designated as safety issue: No ]

Enrollment: 56
Study Start Date: January 2009
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1
Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session
 Drug: Nitrousoxide-oxygen and atmospheric air
Nitrousoxide-oxygen and atmospheric air
Other Name: Nitrousoxide-oxygen first
Experimental: Arm 2
Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session
 Drug: Atmospheric air; nitrousoxide-oxygen
Atmospheric air; nitrousoxide-oxygen
Other Name: Atmospheric air first

Detailed Description:

The present study is a randomized, cross-over blinded study on the analgetic effect of nitrousoxide-oxygen on sensitivity of the dental pulp, the skin and muscles.

It is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark

  Eligibility

Ages Eligible for Study:   12 Years to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • ASA-groups I or II
  • 12-15 year of age
  • sound upper central incisors

Exclusion Criteria:

  • difficulties breathing through the nose
  • pregnancy
  • trauma to test teeth
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01022294

Locations
Denmark
Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Sven Poulsen, dr.odont. Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark
  More Information

No publications provided

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01022294     History of Changes
Other Study ID Numbers: M-20070261
Study First Received: November 27, 2009
Last Updated: January 30, 2012
Health Authority: Denmark: Danish Dataprotection Agency
Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by University of Aarhus:
children
analgesia
dental treatment
inhalation

Additional relevant MeSH terms:
Respiratory Aspiration
Toothache
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
 Signs and Symptoms
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain

ClinicalTrials.gov processed this record on May 16, 2013