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

NCT ID: NCT01022294

Last Updated: 2012-01-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-01-31

Study Completion Date

2011-12-31

Brief Summary

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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

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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

Conditions

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Dental Pain Muscle Sensitivity to Pressure Skin Sensitivity to Electric Stimulation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Arm 1

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

Group Type EXPERIMENTAL

Nitrousoxide-oxygen and atmospheric air

Intervention Type DRUG

Nitrousoxide-oxygen and atmospheric air

Arm 2

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

Group Type EXPERIMENTAL

Atmospheric air; nitrousoxide-oxygen

Intervention Type DRUG

Atmospheric air; nitrousoxide-oxygen

Interventions

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Nitrousoxide-oxygen and atmospheric air

Nitrousoxide-oxygen and atmospheric air

Intervention Type DRUG

Atmospheric air; nitrousoxide-oxygen

Atmospheric air; nitrousoxide-oxygen

Intervention Type DRUG

Other Intervention Names

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Nitrousoxide-oxygen first Atmospheric air first

Eligibility Criteria

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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
Minimum Eligible Age

12 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sven Poulsen, dr.odont.

Role: STUDY_CHAIR

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

Locations

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

Aarhus, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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M-20070261

Identifier Type: -

Identifier Source: org_study_id

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