Ignite Creation Date:
2025-12-24 @ 9:10 PM
Ignite Modification Date:
2025-12-29 @ 10:44 PM
Study NCT ID:
NCT04863404
Status:
UNKNOWN
Last Update Posted:
2021-04-28
First Post:
2021-04-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008313', 'term': 'Malocclusion, Angle Class III'}, {'id': 'D063173', 'term': 'Retrognathia'}, {'id': 'C536919', 'term': 'Tietz syndrome'}], 'ancestors': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D014076', 'term': 'Tooth Diseases'}, {'id': 'D009057', 'term': 'Stomatognathic Diseases'}, {'id': 'D007569', 'term': 'Jaw Abnormalities'}, {'id': 'D007571', 'term': 'Jaw Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D019767', 'term': 'Maxillofacial Abnormalities'}, {'id': 'D019465', 'term': 'Craniofacial Abnormalities'}, {'id': 'D009139', 'term': 'Musculoskeletal Abnormalities'}, {'id': 'D008336', 'term': 'Mandibular Diseases'}, {'id': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008397', 'term': 'Masks'}], 'ancestors': [{'id': 'D058257', 'term': 'Surgical Attire'}, {'id': 'D004865', 'term': 'Equipment and Supplies, Hospital'}, {'id': 'D004864', 'term': 'Equipment and Supplies'}, {'id': 'D011482', 'term': 'Protective Devices'}, {'id': 'D000067393', 'term': 'Personal Protective Equipment'}, {'id': 'D013523', 'term': 'Surgical Equipment'}, {'id': 'D008420', 'term': 'Manufactured Materials'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': '3 arm parallel clinical trial'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 42}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2020-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-10-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-04-27', 'studyFirstSubmitDate': '2021-04-21', 'studyFirstSubmitQcDate': '2021-04-27', 'lastUpdatePostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-05-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pre-treatment (T0) cephalometric analysis measures', 'timeFrame': '0 month', 'description': 'A cephalometric analysis of skeletal maxillary (SNA) and mandibular (SNB) positions'}, {'measure': 'Pre-treatment (T0) soft tissues measurements', 'timeFrame': '0 month', 'description': 'Maxillary and mandibular (Soft tissue convexity angle) soft tissue analysis using 3D stereophotogrammetry'}], 'secondaryOutcomes': [{'measure': 'Post-treatment (T1) cephalometric analysis measurements', 'timeFrame': 'An average of 6 month', 'description': 'Evaluation of pos-treatment cephalometric changes of skeletal maxillary (SNA) and mandibular (SNB) positions'}, {'measure': 'Post-treatment (T1) soft tissues measurements', 'timeFrame': 'An average of 6 month', 'description': 'Evaluation of maxillary and mandibular soft tissue changes (Soft tissue convexity angle) using 3D stereophotogrammetry'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['maxillary protraction', 'tooth-borne vs bone-anchored', 'face mask', 'AltRamec', 'rme', 'Temporary anchorage devices (TADs) in the anterior palate', 'hybrid hyrax'], 'conditions': ['Anterior Crossbite', 'Class III Malocclusion', 'Maxillary Deficiency']}, 'descriptionModule': {'briefSummary': 'The aim of this prospective randomized controlled clinical study is to compare the effects of bone-anchored and tooth borne maxillary protraction on dentofacial structures in skeletal Class III patients.', 'detailedDescription': 'Today, the treatment of class III malocclusion is becoming more important due to the increased awareness of people about their appearance and the impact of appearance on the psychosocial state.\n\nVarious studies have shown that 40% of class III malocclusions are clinically caused by maxillary deficiency, 42% by mandibular excess, and 18% by a combination of maxillary deficiency and mandibular excess.\n\nThe face mask is the most effective treatment modality for class III malocclusions caused by a maxillary deficiency. The rationale for using a face mask is to apply heavy forces to the midface to advance the maxilla forward. These forces cause disarticulation by initiating resorption and apposition in the sutural articulations. However, undesirable dental effects arise from the use of tooth-borne rapid maxillary expansion (RME) during these treatments. These include loss of anchorage and incisor proclination during the mesialization of the maxillary dentition, extrusion of the upper molars and posterior mandibular rotation, and insufficient anterior displacement of the maxilla (1-3 mm).\n\nStudies have shown that increasing the skeletal effects can reduce post-treatment relapse, one of the most important problems in orthodontics.\n\nTo increase the amount of maxillary skeletal advancement and to minimize the side effects of tooth-borne maxillary expansion and protraction, a new bone-anchored hybrid hyrax appliance has been proposed. Hybrid hyrax treatment has the following advantages over tooth-borne mechanics:\n\n* Since the force is applied close to the center of resistance of the maxilla, counterclockwise rotation of the maxilla and related posterior mandibular rotation are not observed.\n* Transversal forces are applied to premolars or deciduous molars and mini implants without the risk of periodontal damage, fenestration, and dehiscence that may occur with tooth-borne appliances are avoided.\n* Mesial migration of the dentition, proclination of the upper incisors, and occupation of the necessary place for the canines to erupt are avoided.\n* Treatment is minimally invasive.\n* Upper and lower arches remain completely accessible for orthodontic interventions.\n* Only skeletal maxillary advancement is achieved. In our study, additionally, the Alternate Rapid Maxillary Expansion and Constriction (AltRamec) protocol, which increases the skeletal effects during maxillary protraction by providing more effective disarticulation of circummaxillary sutures than conventional rapid maxillary expansion was used.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '13 Years', 'minimumAge': '10 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Late mixed or early permanent dentition\n* C3 or C4 period according to the cervical vertebral maturation method\n* Presence of skeletal class III malocclusion (ANB \\<0 °).\n* Retrusive nasomaxillary complex (Nperp-A \\<1 mm).\n* Presence of dental class III malocclusion\n* Normal or horizontal growth pattern (SNGoGn \\<40 °).\n* Negative overjet (overjet \\<0)\n* Good cooperation\n* Absence of any systemic disease\n* Periodontal health\n* No previous orthodontic treatment\n* No craniofacial deformity\n* No neuromuscular deformity\n* The absence of a congenital anomaly\n\nExclusion Criteria:\n\n* Poor cooperation\n* Early mixed dentition\n* Individuals who have passed the C4 period\n* Craniofacial deformity\n* Congenital anomaly\n* A history of facial trauma Syndromes such as cleft lip and palate'}, 'identificationModule': {'nctId': 'NCT04863404', 'briefTitle': 'Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Izmir Katip Celebi University'}, 'officialTitle': 'Evaluation of the Treatment Effects of Tooth Borne Versus Bone-anchored Protraction Procedures in Class III Patients With Maxillary Deficiency', 'orgStudyIdInfo': {'id': '2021-TDU-DİŞF-0003'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Bone-anchored maxillary protraction group', 'description': 'Face mask with hybrid-hyrax', 'interventionNames': ['Other: Face mask with hybrid-hyrax']}, {'type': 'EXPERIMENTAL', 'label': 'Tooth-borne maxillary protraction group', 'description': 'Face mask with conventional bonded RME', 'interventionNames': ['Other: Face mask with conventional bonded RME']}, {'type': 'NO_INTERVENTION', 'label': 'Control group', 'description': 'Control group consisting of 14 non-treated Class III malocclusion subjects'}], 'interventions': [{'name': 'Face mask with hybrid-hyrax', 'type': 'OTHER', 'description': 'Face mask with hybrid-hyrax', 'armGroupLabels': ['Bone-anchored maxillary protraction group']}, {'name': 'Face mask with conventional bonded RME', 'type': 'OTHER', 'description': 'Face mask with conventional bonded RME', 'armGroupLabels': ['Tooth-borne maxillary protraction group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35640', 'city': 'Izmir', 'state': 'Çiğli', 'status': 'RECRUITING', 'country': 'Turkey (Türkiye)', 'contacts': [{'name': 'Burcin Akan, Phd', 'role': 'CONTACT'}], 'facility': 'Izmir Katip Celebi University,Faculty of Dentistry, Department of Orthodontics', 'geoPoint': {'lat': 38.41273, 'lon': 27.13838}}], 'centralContacts': [{'name': 'Burcin AKAN, Phd', 'role': 'CONTACT', 'email': 'Burcin.yksel@gmail.com', 'phone': '+90 5367103040'}], 'overallOfficials': [{'name': 'Burcin AKAN, Phd', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Academician'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Izmir Katip Celebi University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Burçin Akan', 'investigatorAffiliation': 'Izmir Katip Celebi University'}}}}