Ignite Creation Date:
2025-12-25 @ 1:39 AM
Ignite Modification Date:
2025-12-26 @ 1:06 AM
Study NCT ID:
NCT01022294
Status:
COMPLETED
Last Update Posted:
2012-01-31
First Post:
2009-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014098', 'term': 'Toothache'}, {'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D053120', 'term': 'Respiratory Aspiration'}], 'ancestors': [{'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D005157', 'term': 'Facial Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 56}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-01', 'completionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-01-30', 'studyFirstSubmitDate': '2009-11-27', 'studyFirstSubmitQcDate': '2009-11-27', 'lastUpdatePostDateStruct': {'date': '2012-01-31', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Dental pain (pulp) threshold', 'timeFrame': 'During and after inhalation'}], 'secondaryOutcomes': [{'measure': 'Muscle sensitivity to pressure', 'timeFrame': 'During and after inhalation'}, {'measure': 'Skin sensitivity ot electric stimulation', 'timeFrame': 'During and after inhalation'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['children', 'analgesia', 'dental treatment', 'inhalation'], 'conditions': ['Dental Pain', 'Muscle Sensitivity to Pressure', 'Skin Sensitivity to Electric Stimulation']}, 'descriptionModule': {'briefSummary': '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', 'detailedDescription': '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.\n\nIt is conducted in healthy 12-15 year old Danish children attending public schools in the municipality of Aarhus, Denmark'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '12 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* ASA-groups I or II\n* 12-15 year of age\n* sound upper central incisors\n\nExclusion Criteria:\n\n* difficulties breathing through the nose\n* pregnancy\n* trauma to test teeth'}, 'identificationModule': {'nctId': 'NCT01022294', 'briefTitle': 'Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Analgetic Effect of Nitrousoxide-oxygen Inhalation for Dental Treatment of Children', 'orgStudyIdInfo': {'id': 'M-20070261'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Arm 1', 'description': 'Inhalation of nitrousoxide-oxygen during the first experimental session; inhalation of atmospheric air during the second session', 'interventionNames': ['Drug: Nitrousoxide-oxygen and atmospheric air']}, {'type': 'EXPERIMENTAL', 'label': 'Arm 2', 'description': 'Inhalation of atmospheric air during the first experimental session; inhalation of nitrousoxide-oxygen during the second session', 'interventionNames': ['Drug: Atmospheric air; nitrousoxide-oxygen']}], 'interventions': [{'name': 'Nitrousoxide-oxygen and atmospheric air', 'type': 'DRUG', 'otherNames': ['Nitrousoxide-oxygen first'], 'description': 'Nitrousoxide-oxygen and atmospheric air', 'armGroupLabels': ['Arm 1']}, {'name': 'Atmospheric air; nitrousoxide-oxygen', 'type': 'DRUG', 'otherNames': ['Atmospheric air first'], 'description': 'Atmospheric air; nitrousoxide-oxygen', 'armGroupLabels': ['Arm 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'DK-8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Dept. of Pediatric Dentistry, School of Dentistry, Faculty of Health Sciences, Aarhus University', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Sven Poulsen, dr.odont.', 'role': 'STUDY_CHAIR', 'affiliation': 'Dept. of Pediatric Dentsitry, School of Dentistry, Faculty of Health Sciences, Aarhus University, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}