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

Primary Purpose

Dental Pain, Muscle Sensitivity to Pressure, Skin Sensitivity to Electric Stimulation

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Nitrousoxide-oxygen and atmospheric air
Atmospheric air; nitrousoxide-oxygen
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Pain focused on measuring children, analgesia, dental treatment, inhalation

Eligibility Criteria

12 Years - 15 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Arm 1

Arm 2

Arm Description

Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session

Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session

Outcomes

Primary Outcome Measures

Dental pain (pulp) threshold

Secondary Outcome Measures

Muscle sensitivity to pressure
Skin sensitivity ot electric stimulation

Full Information

First Posted
November 27, 2009
Last Updated
January 30, 2012
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT01022294
Brief Title
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Official Title
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Study Type
Interventional

2. Study Status

Record Verification Date
January 2012
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
December 2011 (Actual)
Study Completion Date
December 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Pain, Muscle Sensitivity to Pressure, Skin Sensitivity to Electric Stimulation
Keywords
children, analgesia, dental treatment, inhalation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Arm 1
Arm Type
Experimental
Arm Description
Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session
Arm Title
Arm 2
Arm Type
Experimental
Arm Description
Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session
Intervention Type
Drug
Intervention Name(s)
Nitrousoxide-oxygen and atmospheric air
Other Intervention Name(s)
Nitrousoxide-oxygen first
Intervention Description
Nitrousoxide-oxygen and atmospheric air
Intervention Type
Drug
Intervention Name(s)
Atmospheric air; nitrousoxide-oxygen
Other Intervention Name(s)
Atmospheric air first
Intervention Description
Atmospheric air; nitrousoxide-oxygen
Primary Outcome Measure Information:
Title
Dental pain (pulp) threshold
Time Frame
During and after inhalation
Secondary Outcome Measure Information:
Title
Muscle sensitivity to pressure
Time Frame
During and after inhalation
Title
Skin sensitivity ot electric stimulation
Time Frame
During and after inhalation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
12 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sven Poulsen, dr.odont.
Organizational Affiliation
Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark
Official's Role
Study Chair
Facility Information:
Facility Name
Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University
City
Aarhus
ZIP/Postal Code
DK-8000
Country
Denmark

12. IPD Sharing Statement

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

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