Ignite Creation Date:
2025-12-25 @ 1:06 AM
Ignite Modification Date:
2026-01-24 @ 1:50 PM
Study NCT ID:
NCT01642693
Status:
COMPLETED
Last Update Posted:
2012-07-17
First Post:
2012-07-13
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Histological Change of The Dentinal-Pulp Complex and Root Resorption
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012391', 'term': 'Root Resorption'}], 'ancestors': [{'id': 'D014091', 'term': 'Tooth Resorption'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-07', 'completionDateStruct': {'date': '2009-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-07-16', 'studyFirstSubmitDate': '2012-07-13', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Teeth with intrusive movement and low power laser', 'timeFrame': '12 weeks', 'description': 'Histological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application'}], 'secondaryOutcomes': [{'measure': 'Teeth with intrusive movements with no laser exposition', 'timeFrame': '12 weeks', 'description': 'Histological changes and root resorption were assesed in Teeth with intrusive movement with no laser exposition'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['root resorption', 'low-power laser', 'orthodontic tooth movement', 'pulp changes'], 'conditions': ['Laser', 'Intrusion', 'Histology', 'Resorption']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.udea.edu.co', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The purpose of the study is evaluate the histological changes of the dentinal-pulp complex and root resorption in maxillary premolars with intrusive orthodontic movement under a low power laser effects.', 'detailedDescription': 'Orthodontics movements can cause inflamatory changes in the pulp and external inflamatory root resorption, different methods have been suggested to control that changes as the use of the low power laser. The objective of this study is to evaluate the low power laser effect on the inflamatory pulpar change and inflamatory external root resorption in maxillary premolars with intrusive orthodontic movements of 4 ounces during 12 weeks. Total sample were 34 healthy teeth, 16 were used to evaluate the normal standar and 18 were divided in two groups, the experimental group with the low power laser effect had a dose of 18 joules after activations of the orthodontic intrusion and the control group had a simulated effect in the same orthodontic movement. Teeth were extacted after 12 weeks and histological changes were evaluated in the dentinal-pulp complex and the pesence of external inflamatory root resorption. Findins suggest that low power. Laser decreased the inflamatory changes of the dentinal - pulp complex and the severity of the external inflamatory root resorption.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '23 Years', 'minimumAge': '13 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with first premolar extraction indicated\n* Patients with no sistemic diseases\n* Healthy premolars with completed root and no trauma or restoration\n\nExclusion Criteria:\n\n* Sistemics diseased\n* Restoration, trauma in first premolars\n* root uncompleted'}, 'identificationModule': {'nctId': 'NCT01642693', 'briefTitle': 'Histological Change of The Dentinal-Pulp Complex and Root Resorption', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Antioquia'}, 'officialTitle': 'Histological Changes of The Dentinal-Pulp Complex and Root Resorption in Maxillary Premolars With Intrusive Orthodontic Movements Under a Low Power Laser Effect', 'orgStudyIdInfo': {'id': '2006-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Teeth with intrusive movement and low power laser', 'description': 'Histological changes and root resorption were assesed in Teeth with intrusive movement after a low power laser application', 'interventionNames': ['Radiation: Low power laser in teeth after intrusive movement']}, {'type': 'EXPERIMENTAL', 'label': 'Teeth with intrusive movements with no laser', 'description': 'Histological changes and root resorption in Teeth with intrusive movements with no laser', 'interventionNames': ['Other: Simulated laser in teeth with intrusive movements']}], 'interventions': [{'name': 'Low power laser in teeth after intrusive movement', 'type': 'RADIATION', 'description': 'Low power laser was aplied to premolar teeth under an intrusive movement to study histological changes and root resorption', 'armGroupLabels': ['Teeth with intrusive movement and low power laser']}, {'name': 'Simulated laser in teeth with intrusive movements', 'type': 'OTHER', 'description': 'Simulated laser in teeth with intrusive movements for histological and root resorption changes', 'armGroupLabels': ['Teeth with intrusive movements with no laser']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Medellín', 'state': 'Antioquia', 'country': 'Colombia', 'facility': 'Paula Villa M', 'geoPoint': {'lat': 6.245, 'lon': -75.57151}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Antioquia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Partial time proffesor in Endodontics', 'investigatorFullName': 'Paula Villa M', 'investigatorAffiliation': 'Universidad de Antioquia'}}}}