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Completed

NCT Number: NCT01022294

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

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

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Key information

Conditions

Dental Pain Agnosia Facial Pain Muscle Sensitivity to Pressure Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Signs and Symptoms Skin Sensitivity to Electric Stimulation Stomatognathic Diseases Tooth Diseases Toothache

Age range

12 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Aarhus, DK-8000, Denmark

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nitrousoxide-oxygen and atmospheric air

Drug

Nitrousoxide-oxygen and atmospheric air

Other names: Nitrousoxide-oxygen first

Atmospheric air; nitrousoxide-oxygen

Drug

Atmospheric air; nitrousoxide-oxygen

Other names: Atmospheric air first

Primary outcomes

  1. Dental pain (pulp) threshold

    Time frame: During and after inhalation

Secondary outcomes

  1. Muscle sensitivity to pressure

    Time frame: During and after inhalation

  2. Skin sensitivity ot electric stimulation

    Time frame: During and after inhalation

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Dec 1, 2009
Registry last updated
Jan 31, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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