Ignite Creation Date:
2025-12-24 @ 11:52 PM
Ignite Modification Date:
2026-01-02 @ 10:26 AM
Study NCT ID:
NCT04825951
Status:
COMPLETED
Last Update Posted:
2023-02-03
First Post:
2021-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008313', 'term': 'Malocclusion, Angle Class III'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Participants and statistician will be blinded (double blind) to the intervention group. After data collection is completed, the randomization code will be broken to reveal the allocation group. The operator will be blinded during recording of the measurements.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'randomized controlled clinical trial, parallel design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 33}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-02', 'completionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-02', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2023-02-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Skeletal readings angles', 'timeFrame': '6 months', 'description': 'SNA in degrees SNB in degrees ANB in degrees SN-MP in degrees'}, {'measure': 'Skeletal readings percetanges', 'timeFrame': '6 months', 'description': 'LAFH in percentage'}, {'measure': 'Skeletal readings in millimeters', 'timeFrame': '6 months', 'description': 'Wits appraisal in millimeters'}, {'measure': 'Dental readings angles', 'timeFrame': '6 months', 'description': 'U1-PP in degrees U1- NA in degrees L1-MP in degrees L1-NB in degrees'}, {'measure': 'Dental readings in millimeters', 'timeFrame': '6 months', 'description': 'U1-NA millimeters L1-NB in millimeters.'}, {'measure': 'Soft tissue readings in millimeters', 'timeFrame': '6 months', 'description': 'UL- E plane in millimeters LL- E plane in millimeters'}], 'secondaryOutcomes': [{'measure': 'Changes in airway', 'timeFrame': '6 months', 'description': 'difference in airway volume in cubic millimeters .'}, {'measure': 'Changes in TMJ', 'timeFrame': '6 months', 'description': 'anterior, posterior, superior and medial joint space in cubic milimeters.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cone beam computed tomography', 'growing skeletal Class III', 'CS 2000® appliance', 'Reversed Forsus Fatigue resistant device'], 'conditions': ['Malocclusion, Angle Class III']}, 'referencesModule': {'references': [{'pmid': '32005472', 'type': 'BACKGROUND', 'citation': 'Oliveira PM, Cheib-Vilefort PL, de Parsia Gontijo H, Melgaco CA, Franchi L, McNamara JA Jr, Souki BQ. Three-dimensional changes of the upper airway in patients with Class II malocclusion treated with the Herbst appliance: A cone-beam computed tomography study. Am J Orthod Dentofacial Orthop. 2020 Feb;157(2):205-211. doi: 10.1016/j.ajodo.2019.03.021.'}, {'pmid': '11357217', 'type': 'RESULT', 'citation': 'World Medical Association.. World Medical Association Declaration of Helsinki. Ethical principles for medical research involving human subjects. Bull World Health Organ. 2001;79(4):373-4. Epub 2003 Jul 2. No abstract available.'}]}, 'descriptionModule': {'briefSummary': 'Early orthodontic treatment of Class III malocclusions with skeletal and dentoalveolar imbalances, represents a continuous dilemma. This difficulty starts from their meticulous diagnosis and treatment planning till reaching satisfactory results and finally stability. Some appliances could be used to correct growing skeletal Class III patients, improving the skeletal and dentoalveolar relationships, creating proper conditions for final orthodontic treatment, more importantly avoiding surgery. These appliances remove patient compliance from the equation.', 'detailedDescription': 'Aim of the work: Evaluate the skeletal, dentoalveolar and soft tissue effects of two different force application systems which are the pulling force (CS 2000® appliance/ CS appliance) and the pushing force (Reversed Forsus fatigue-resistant device/ RF appliance).\n\nMaterials and methods: A randomized controlled clinical trial will be conducted to address the aim of the study. Thirty three growing skeletal Class III patients (9-11 years) will be recruited upon a lateral cephalometric x-ray. Subjects complying with the inclusion criteria will be randomly assigned using a computer-generated list to one of the three groups Group I: Eleven patients treated with CS2000 appliance, Group II: Eleven patients treated with reversed Forsus Fatigue Resistant device and Group III: control group of Eleven untreated patients with a ratio of 1:1:1 allocation. A CBCT will be made before installing the appliances. After gaining a 2 mm positive overjet or a 6 months period, alginate impressions will be poured and dental casts will be made. Photographs and CBCTs will also be performed to record the dentofacial effect of the used appliances.\n\nKeywords: Cone beam computed tomography, growing skeletal Class III, CS 2000® appliance, Reversed Forsus Fatigue resistant device.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '11 Years', 'minimumAge': '8 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age range from 8 years to 11 years.\n* Cervical vertebrae maturation index (CVMI 2 and 3) identified on the lateral cephalometric radiograph.\n* Angle Class III molar relation.\n* Skeletal class III ANB ranges between (-4) - (0).\n* Wits appraisal ranges between (0) - (-5).\n* Patients with good oral hygiene, and a healthy periodontal condition.\n* Reversed over jet (-1) - (-6).\n* Normal vertical growth pattern (SN/MP angle 28˚-38˚).\n\nExclusion Criteria:\n\n* A discrepancy between centric relation and maximum intercuspation.\n* Patients who underwent previous orthodontic treatment.\n* Patients currently receiving drug therapy that may affect orthodontic tooth movement.\n* Congenitally missing teeth or extracted teeth.\n* History of systemic disease or craniofacial syndromes or presence of cleft.'}, 'identificationModule': {'nctId': 'NCT04825951', 'briefTitle': 'Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients', 'organization': {'class': 'OTHER', 'fullName': 'Alexandria University'}, 'officialTitle': 'Three Dimensional Evaluation Of Dentofacial Effects Of Two Non-Compliance Appliances In The Treatment Of Growing Skeletal Class III Patients (A Randomized Controlled Clinical Trial)', 'orgStudyIdInfo': {'id': '070320212'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CS 2000 appliance', 'description': 'treating growing skeletal Class III patients', 'interventionNames': ['Other: CS 2000']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Reversed Forsus Fatigue resistant appliance', 'description': 'treating growing skeletal Class III patients', 'interventionNames': ['Other: CS 2000']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'A group of untreated skeletally growing class III patients will be recruited to account for the possible effects of growth in the treatment groups.\n\nThis group matches the treated groups in malocclusion, stages of skeletal maturation, and mean observation period. Those patients will be treated after the period of the study.'}], 'interventions': [{'name': 'CS 2000', 'type': 'OTHER', 'otherNames': ['Reversed Forsus Fatigue resistant appliance'], 'description': 'treating growing Skeletal growing Class III patients', 'armGroupLabels': ['CS 2000 appliance', 'Reversed Forsus Fatigue resistant appliance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03', 'city': 'Alexandria', 'country': 'Egypt', 'facility': 'Alexandria University Faculty of Dentistry', 'geoPoint': {'lat': 31.20176, 'lon': 29.91582}}], 'overallOfficials': [{'name': 'Bassant A Abbas, PHD resident', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Alexandria University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'TREATMENT OF GROWING SKELETAL CLASS III PATIENTS'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alexandria University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'principal investigator', 'investigatorFullName': 'Bassant Alaa', 'investigatorAffiliation': 'Alexandria University'}}}}