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NCT01022294 Clinical Trial

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

Dental Pain Clinical Trial

Official title:
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01022294
Other study ID # M-20070261
Secondary ID
Status Completed
Phase N/A
First received November 27, 2009
Last updated January 30, 2012
Start date January 2009
Est. completion date December 2011

Study information
Verified date January 2012
Source University of Aarhus
Contact n/a
Is FDA regulated No
Health authority Denmark: Danish Dataprotection AgencyDenmark: The Regional Committee on Biomedical Research Ethics
Study type Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility
Status Completed
Enrollment 56
Est. completion date December 2011
Est. primary completion date December 2011
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 12 Years to 15 Years
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Nitrousoxide-oxygen and atmospheric air
Nitrousoxide-oxygen and atmospheric air
• Atmospheric air; nitrousoxide-oxygen
Atmospheric air; nitrousoxide-oxygen

Locations
Country Name City State
Denmark Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University Aarhus

Sponsors (1)
Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome
Type Measure Description Time frame Safety issue
Primary Dental pain (pulp) threshold During and after inhalation No
Secondary Muscle sensitivity to pressure During and after inhalation No
Secondary Skin sensitivity ot electric stimulation During and after inhalation No
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