Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-01-10 @ 5:35 PM
Study NCT ID:
NCT03180151
Status:
COMPLETED
Last Update Posted:
2023-10-03
First Post:
2016-12-25
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Corticotomy in En-mass Retraction
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-09', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-10-02', 'studyFirstSubmitDate': '2016-12-25', 'studyFirstSubmitQcDate': '2017-06-06', 'lastUpdatePostDateStruct': {'date': '2023-10-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'rate of tooth movement per time', 'timeFrame': '4 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['corticotomy', 'enmass retraction', 'mini implant'], 'conditions': ['Accelerate Tooth Movement']}, 'referencesModule': {'references': [{'pmid': '33435897', 'type': 'DERIVED', 'citation': 'Hatrom AA, Howait MS, Zawawi KH, Al-Turki GA, Alansari RA, Almehayawi NF, Alammari SH, Mohammed RA, Hassan AH. Pulp volume changes after piezocision-assisted tooth movement: a randomized clinical trial. BMC Oral Health. 2021 Jan 13;21(1):28. doi: 10.1186/s12903-020-01382-2.'}]}, 'descriptionModule': {'briefSummary': '* To compare patients who will undergo orthodontics treatment involving upper premolar extraction for space of time whether with or without corticotomy by Piezotome.\n* Assess the safety of both methods of retraction in regard to the quality of the surrounding periodontium and roots of anterior teeth.\n* Monitor postoperative pain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '26 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* On the basis of the diagnosis of the malocclusion, individuals who have Class I and Class II malocclusions and requiring extraction of premolars and retraction of anterior teeth will be selected (maxillary/mandibular or both).\n* Good oral hygiene, healthy gingiva and no evidence of bone loss as seen in radiograph.\n* Healthy systemic conditions.\n* No previous orthodontic treatment.\n* Patient needs to be in permanent dentition (hence, we need to define their age range).\n\nExclusion Criteria:\n\n* Patient with systemic disease.\n* Patient having any signs of active periodontal disease.\n* Patients on long-term corticosteroid therapy.\n* Persons taking medications that slows down bone metabolism.\n* Craniofacial anomalies.'}, 'identificationModule': {'nctId': 'NCT03180151', 'briefTitle': 'The Effect of Corticotomy in En-mass Retraction', 'organization': {'class': 'OTHER', 'fullName': 'King Abdulaziz University'}, 'orgStudyIdInfo': {'id': '078-16'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Orthodontic tooth movement group', 'description': 'This is the control group in which pateints will be treated by conventional orthodontic treatment and extraction of premolars without piezotome'}, {'type': 'EXPERIMENTAL', 'label': 'Corticotomy assisted orthodontic group', 'description': 'This is the study group in which patients will be treated by conventional orthodontic treatment aided by corticotomy procedure perfumed by using a piezotome.(piezotome assisted orthodontic tooth movement)', 'interventionNames': ['Procedure: piezotome assisted orthodontic tooth movement']}], 'interventions': [{'name': 'piezotome assisted orthodontic tooth movement', 'type': 'PROCEDURE', 'otherNames': ['corticotomy assisted tooth movement'], 'description': "Surgical procedure\n\n1. After local anesthesia, vertical interproximal incisions will be done under the interdental papilla, on the labial aspect of upper arch using a blade No. 15.\n2. The incisions will be kept minimal.\n3. The incisions go though the periosteum, which permit the blade to reach to the alveolar bone.\n4. A Piezo surgical knife will be used to make the cortical alveolar incision through the gingival incisions to a depth of approximately 3mm.\n5. As we will not use bone graft so we don't need use suturing after cortication.\n6. We give patient antibiotic and analgesic cover.", 'armGroupLabels': ['Corticotomy assisted orthodontic group']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'After publication, data can be shared with others upon request via email to the corresponding author.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'King Abdulaziz University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor in orthodontic department', 'investigatorFullName': 'Ali Habiballah Hassan', 'investigatorAffiliation': 'King Abdulaziz University'}}}}