Ignite Creation Date:
2025-12-24 @ 5:17 PM
Ignite Modification Date:
2025-12-24 @ 5:17 PM
Study NCT ID:
NCT02549950
Status:
UNKNOWN
Last Update Posted:
2015-09-15
First Post:
2015-09-11
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008311', 'term': 'Malocclusion, Angle Class I'}, {'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-09-14', 'studyFirstSubmitDate': '2015-09-11', 'studyFirstSubmitQcDate': '2015-09-14', 'lastUpdatePostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-09-15', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of orthodontic canine movement', 'timeFrame': '4-6 months'}], 'secondaryOutcomes': [{'measure': 'Rate of orthodontic Incisor Retraction', 'timeFrame': '4-6 months'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Accelerated orthodontic tooth movement (AOTM)', 'Peizo-corticission'], 'conditions': ['Malocclusion, Angle Class I', 'Malocclusion; Angle Class II Division 1']}, 'referencesModule': {'references': [{'pmid': '23810039', 'type': 'BACKGROUND', 'citation': 'Mathews DP, Kokich VG. Accelerating tooth movement: the case against corticotomy-induced orthodontics. Am J Orthod Dentofacial Orthop. 2013 Jul;144(1):5-13. doi: 10.1016/j.ajodo.2013.04.008. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to provide evidence on the effectiveness, the efficiency and efficacy of Peizo-Corticission in accelerating orthodontic tooth movement and reducing orthodontic treatment time.', 'detailedDescription': '1 Aim of the study- Part I:\n\nThis prospective controlled clinical trial (CCT), Split Mouth Design is conducted to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of canine teeth in class II div 1 subjects.\n\nSpecific aim- Part I:\n\nA- To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved canines\n\nB- To compare length of treatment of both approaches.\n\n2- Objectives of the Study Part II:\n\nThis prospective randomized controlled clinical trial (RCT) is designed to assess the efficiency of piezo-corticision in accelerating tooth movement and in reducing treatment time during retraction of anterior teeth in class II div 1 and class 1 bi-maxillary protrusive subjects.\n\nSpecific aim Part II:\n\n1. To compare rate of tooth retraction between piezo-corticised and the conventionally orthodontically moved incisors\n2. To compare length of treatment of both approaches.\n3. To evaluate the quality of treatment outcome of both treatment approaches according to American Board of Orthodontics (ABO) standards.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '35 Years', 'minimumAge': '15 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Study Subjects for Part I and Part II:\n\nInclusion:\n\n* Voluntary participation of patients only\n* Able to follow instruction, able to understand the consent form and sign it.\n* Adult Female and Male Saudi patients 15-35 y.o\n* Subjects who are none smokers\n* Subjects with good health according to American Society of Anesthesiology ASA-I with full permanent dentition regardless of the third molars.\n* Subjects with good periodontal and gingival health: Gingival Index GI≤ 1\n* Subjects with a none gummy smile,\n* Subjects with full complement of permanent caries-free dentition; Restored teeth should be of proper sound intact fillings\n* Subjects without root anomalies\n* Subjects with mild-moderate skeletal and dental cephalometric measurements: OB ≤ 40%, OJ ≤ 6, ANB ≤ 5 °, SN-GOGN ≤ 29 °, Subjects' dentition Angle classification class II div 1, 3mm molar and canine occlussal relationship; and subjects with class 1 Bi-maxillary protrusion\n\nExclusion:\n\n* Subjects younger than 15 y.o\n* Subjects who cannot comprehend the surgical procedure and who cannot consent for themselves\n* Subjects who are medically classified as ASA-II, III\n* Subjects who are taking any systemic or local medications especially Insulin, non-steroidal anti-inflammatory drugs, bisphosphonate, corticosteroids\n* Subjects who are pregnant\n* Subjects who are smokers\n* Subjects with craniofacial syndromes: cleft lip and palate; or facial trauma\n* Subjects with unhealthy or compromised periodontium\n* Subjects with a gummy smile\n* Subjects with inadequately treated endodontic and dental fillings problems\n* Subjects with previous root resorption or dental developmental anomalies\n* Subjects who had previous orthodontic treatment\n* Subjects with TMJ signs and symptoms; Mandibular functional shift\n* Subjects with extreme skeletal and dental class II: SN-GOGN ≥ 32°, OJ ≥ 6mm\n* Subjects will be excluded if broken brackets or lost coils which have not been replaced immediately within few days from breakage or loss.\n* Subjects will be excluded if any of mini-screws failed during treatment\n* Subjects who become medically unfit during course of trial"}, 'identificationModule': {'nctId': 'NCT02549950', 'briefTitle': 'Efficiency of Piezo-Corticision in Accelerating Orthodontic Tooth Movement', 'organization': {'class': 'OTHER', 'fullName': 'King Abdullah International Medical Research Center'}, 'officialTitle': 'Efficiency and Efficacy of Peizo-Coticision in Reducing Orthodontic Treatment Time: Randomized Clinical Trial', 'orgStudyIdInfo': {'id': 'RC13/261/R'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Conventional OrthodonticTreatment', 'description': 'Conventional orthodontic mechanics: canine and incisor retraction', 'interventionNames': ['Procedure: Conventional Orthodontic Mechanics']}, {'type': 'EXPERIMENTAL', 'label': 'Accelerated Tooth Movement', 'description': 'Accelerated orthodontics: Peizo-Corticision Accelerated canine and Incisor retraction', 'interventionNames': ['Procedure: Peizocorticision']}], 'interventions': [{'name': 'Peizocorticision', 'type': 'PROCEDURE', 'otherNames': ['AOTM Accelerated Orthodontic Tooth Movement'], 'description': 'Peizocorticision a non invasive procedure used in/ to accelerate orthodontic tooth movement', 'armGroupLabels': ['Accelerated Tooth Movement']}, {'name': 'Conventional Orthodontic Mechanics', 'type': 'PROCEDURE', 'otherNames': ['Conv Orth Mech'], 'description': 'Full Fixed Orthodontic Appliance with conventional orthodontic Mechanics', 'armGroupLabels': ['Conventional OrthodonticTreatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11426', 'city': 'Riyadh', 'status': 'RECRUITING', 'country': 'Saudi Arabia', 'contacts': [{'name': 'SALLY K AL-YOUSEF', 'role': 'CONTACT', 'email': 'alyousefsa@ngha.med.sa', 'phone': '00966118011111', 'phoneExt': '14036'}], 'facility': 'National Guard Hospital', 'geoPoint': {'lat': 24.68773, 'lon': 46.72185}}], 'centralContacts': [{'name': 'Sally K Al-Yousef, Msc-Ortho', 'role': 'CONTACT', 'email': 'alyousefsa@ngha.med.sa', 'phone': '00966-11-8011111', 'phoneExt': '14036'}], 'overallOfficials': [{'name': 'Sally K Al-Yousef, MSc-Ortho', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'KAIMRC'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AL Yousef', 'class': 'OTHER'}, 'collaborators': [{'name': 'King Abdullah International Medical Research Center', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Sally K Al Yousef BDS; AEGD; GPR; MSc-Orthodontics', 'investigatorFullName': 'AL Yousef', 'investigatorAffiliation': 'King Abdullah International Medical Research Center'}}}}