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

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ClinicalTrials.gov Identifier: NCT01022294
Recruitment Status : Completed
First Posted : December 1, 2009
Last Update Posted : January 31, 2012
Sponsor:
Information provided by (Responsible Party):
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

Condition or disease Intervention/treatment Phase
Dental Pain Muscle Sensitivity to Pressure Skin Sensitivity to Electric Stimulation Drug: Nitrousoxide-oxygen and atmospheric air Drug: Atmospheric air; nitrousoxide-oxygen Not Applicable

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Study Start Date : January 2009
Actual Primary Completion Date : December 2011
Actual Study Completion Date : December 2011

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Arm Intervention/treatment
Experimental: Arm 1
Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session
Drug: Nitrousoxide-oxygen and atmospheric air
Nitrousoxide-oxygen and atmospheric air
Other Name: Nitrousoxide-oxygen first

Experimental: Arm 2
Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session
Drug: Atmospheric air; nitrousoxide-oxygen
Atmospheric air; nitrousoxide-oxygen
Other Name: Atmospheric air first




Primary Outcome Measures :
  1. Dental pain (pulp) threshold [ Time Frame: During and after inhalation ]

Secondary Outcome Measures :
  1. Muscle sensitivity to pressure [ Time Frame: During and after inhalation ]
  2. Skin sensitivity ot electric stimulation [ Time Frame: During and after inhalation ]


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Ages Eligible for Study:   12 Years to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022294


Locations
Denmark
Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University
Aarhus, Denmark, DK-8000
Sponsors and Collaborators
University of Aarhus
Investigators
Study Chair: Sven Poulsen, dr.odont. Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark

Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT01022294     History of Changes
Other Study ID Numbers: M-20070261
First Posted: December 1, 2009    Key Record Dates
Last Update Posted: January 31, 2012
Last Verified: January 2012

Keywords provided by University of Aarhus:
children
analgesia
dental treatment
inhalation

Additional relevant MeSH terms:
Hypersensitivity
Respiratory Aspiration
Toothache
Immune System Diseases
Respiration Disorders
Respiratory Tract Diseases
Pathologic Processes
Tooth Diseases
Stomatognathic Diseases
Facial Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms