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

January 30, 2012 updated by: University of Aarhus
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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark, DK-8000
        • Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years to 15 years (Child)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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 Names:
  • 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 Names:
  • Atmospheric air first

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Dental pain (pulp) threshold
Time Frame: During and after inhalation
During and after inhalation

Secondary Outcome Measures

Outcome Measure
Time Frame
Muscle sensitivity to pressure
Time Frame: During and after inhalation
During and after inhalation
Skin sensitivity ot electric stimulation
Time Frame: During and after inhalation
During and after inhalation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Investigators

  • Study Chair: Sven Poulsen, dr.odont., Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Actual)

December 1, 2011

Study Completion (Actual)

December 1, 2011

Study Registration Dates

First Submitted

November 27, 2009

First Submitted That Met QC Criteria

November 27, 2009

First Posted (Estimate)

December 1, 2009

Study Record Updates

Last Update Posted (Estimate)

January 31, 2012

Last Update Submitted That Met QC Criteria

January 30, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M-20070261

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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