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

Not Applicable

Completed

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

• Registration Number: NCT01022294
• Lead Sponsor: University of Aarhus

Brief 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

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 Timeline

• Study Start: 2009-01
• Study First Submitted: 2009-11-27
• Study First Submitted QC: 2009-11-27
• Study First Posted: 2009-12-01
• Primary Completion: 2011-12
• Study Completion: 2011-12
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-30
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Arm 1	Nitrousoxide-oxygen and atmospheric air	Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session
Arm 2	Atmospheric air; nitrousoxide-oxygen	Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session

Primary Outcome Measures

Name	Time	Method
Dental pain (pulp) threshold	During and after inhalation

Secondary Outcome Measures

Name	Time	Method
Muscle sensitivity to pressure	During and after inhalation
Skin sensitivity ot electric stimulation	During and after inhalation

Trial Locations

Locations (1)

Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University; 🇩🇰 Aarhus, Denmark