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
  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:


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
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: 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
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 31, 2014