Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-24 @ 4:37 PM
Study NCT ID:
NCT03782766
Status:
COMPLETED
Last Update Posted:
2018-12-20
First Post:
2018-12-15
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Mandibular Second Molar Protraction Assisted by Piezocision
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Three models:-\n\n* Split mouth design where piezocision will be performed on the right of left side of the patient in bilateral first molar extraction space subjects.\n* comparison between 2 groups of subjects; one group where protraction is done with piezocision and the other group where protraction was done with no piezocision.\n* third part where the same side of space receives the 2 interventions. Molar protraction started with no piezocision for 3 months followed by piezocision and protraction for another 3 months,'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-09-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-12', 'completionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-12-19', 'studyFirstSubmitDate': '2018-12-15', 'studyFirstSubmitQcDate': '2018-12-19', 'lastUpdatePostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of second molar protraction', 'timeFrame': 'up to 3 months', 'description': 'measured in mm/month from onscreen dental cast'}, {'measure': 'Changes in the level of of Interleukin1-β', 'timeFrame': 'Immediately before protraction/piezocision, 1 day, 1 week and 4 weeks after protraction/piezocision', 'description': 'detected in Gingival crevicular fluid (GCF)'}], 'secondaryOutcomes': [{'measure': 'Anchorage loss', 'timeFrame': 'Each month up to 3 months', 'description': 'Distal movement of second premolar in mm per month'}, {'measure': 'Pain Perception: Visual analogue scale (VAS)', 'timeFrame': 'Every day up to 7 days', 'description': 'Assessed using visual analog scale (VAS) where 0 = no pain and 10 = worst pain. The participants filled out questionnaire to assess the pain intensity and interference after second molar protraction with or without piezocision on 1, 2, 3, 4, 5, 6 and 7 days of intervention.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Piezocision', 'Temporary anchorage device', 'molar protraction'], 'conditions': ['Acceleration of Tooth Movement', 'Piezocision']}, 'descriptionModule': {'briefSummary': 'This study was conducted to compare the rate of second molar protraction, level of Interleukin1-β in gingival crevicular fluid, periodontal health (gingival index, plaque index, and periodontal pocket depth) and perception of pain in patients treated by molar protraction with piezocision vs control (no piezocision).', 'detailedDescription': 'Twenty-six subjects (39 Molars) who presented with at least one extracted mandibular first molar were selected to participate in the study. The subjects were subdivided into one of 3 groups as follows: group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocision was performed immediately before molar protraction; group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocision; group 3 consisted of 21 molars (group 2 subjects where piezocision was carried on after 3 months of molar protraction with no piezocision. After reaching 0.019X0.025" SS arch wire, NiTi coil spring was used for space closure (protraction force was 150g) attached from the lower second molar hook to the head of the mini-screw. Piezocision was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.\n\nGingival crevicular fluid (GCF) sample was obtained from the mesiogingival side of the lower second permanent molar with use of Periopaper. GCF sample was repeated 1 day, 1 week and 4 weeks after molar protraction with piezocision or with no piezocision. Pain was assessed using visual analog scale (VAS). Patients were requested to report the level of pain for 7 consecutive days.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '27 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age range from 20 to 27 years\n* at least one extracted mandibular first molar (first molar extracted more than one year ago and residual extraction space more than 5 mm)\n* Class 1 malocclusion where molar protraction is indicated\n* all permanent teeth are present except for the extracted mandibular first molar/molars.\n\nExclusion Criteria:-\n\n* Ggingival index score \\> 2\n* Plaque index score \\> 2\n* Probing depth \\> 4mm\n* Previous orthodontic treatment\n* Systemic disease and\n* Smoker.'}, 'identificationModule': {'nctId': 'NCT03782766', 'briefTitle': 'Mandibular Second Molar Protraction Assisted by Piezocision', 'organization': {'class': 'OTHER', 'fullName': 'Jordan University of Science and Technology'}, 'officialTitle': 'Mandibular Second Molar Protraction Assisted by and Piezocision', 'orgStudyIdInfo': {'id': '416/2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'piezosurgery', 'description': 'group 1 consisted of 18 molars (13 molars from patients with bilateral first molar extraction space and 5 molars from patients with unilateral first molar extraction space) where piezocesion was performed immediately before molar protraction', 'interventionNames': ['Procedure: Piezocision']}, {'type': 'NO_INTERVENTION', 'label': 'No piezocision', 'description': 'group 2 consisted of 21 molars (13 from patients with bilateral first molar extraction space and 8 molars from patients with unilateral first molar extraction space) where molar protraction was performed with no piezocesion'}, {'type': 'OTHER', 'label': 'Late piezocision', 'description': 'group 3 consisted of 21 molars (group 2 subjects where piezocession was carried on after 3 months of molar protraction with no piezocesion.', 'interventionNames': ['Procedure: Piezocision']}], 'interventions': [{'name': 'Piezocision', 'type': 'PROCEDURE', 'description': 'Piezocesion was performed by making 2 vertical incisions mesial and distal to the extraction space. Piezotome was inserted in the incisions previously made and bone cuts were done with a length up to mucogingival line and depth of 3 mm.', 'armGroupLabels': ['Late piezocision', 'piezosurgery']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Elham S A Alhaija', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Prof.- Main thesis supervisor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jordan University of Science and Technology', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator - Main thesis supervisor', 'investigatorFullName': 'Elham Abu Alhaija', 'investigatorAffiliation': 'Jordan University of Science and Technology'}}}}