Ignite Creation Date:
2025-12-24 @ 11:37 PM
Ignite Modification Date:
2025-12-25 @ 9:27 PM
Study NCT ID:
NCT05993156
Status:
UNKNOWN
Last Update Posted:
2023-08-15
First Post:
2023-07-06
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008310', 'term': 'Malocclusion'}, {'id': 'D008312', 'term': 'Malocclusion, Angle Class II'}, {'id': 'D008844', 'term': 'Micrognathism'}], 'ancestors': [{'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': 'D018640', 'term': 'Stomatognathic System Abnormalities'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 24}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-13', 'studyFirstSubmitDate': '2023-07-06', 'studyFirstSubmitQcDate': '2023-08-13', 'lastUpdatePostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Over jet reduction', 'timeFrame': '9 months', 'description': 'the horizontal distance between upper and lower incisors'}], 'secondaryOutcomes': [{'measure': 'Effective mandibular length', 'timeFrame': '9 months', 'description': 'distance from condylon to the Pogonion points'}, {'measure': 'lower incisor inclination', 'timeFrame': '9 months', 'description': 'inclination of lower incisors on the mandibular plane'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['orthodontics', 'orthopedics', 'myofunctional appliance', 'Twinblock'], 'conditions': ['Malocclusion', 'Angle Class II', 'Mandible Small']}, 'referencesModule': {'references': [{'pmid': '30672991', 'type': 'BACKGROUND', 'citation': 'Alhammadi MS, Halboub E, Fayed MS, Labib A, El-Saaidi C. Global distribution of malocclusion traits: A systematic review. Dental Press J Orthod. 2018 Nov-Dec;23(6):40.e1-40.e10. doi: 10.1590/2177-6709.23.6.40.e1-10.onl.'}, {'pmid': '25296729', 'type': 'BACKGROUND', 'citation': 'Burhan AS, Nawaya FR. Dentoskeletal effects of the Bite-Jumping Appliance and the Twin-Block Appliance in the treatment of skeletal Class II malocclusion: a randomized controlled trial. Eur J Orthod. 2015 Jun;37(3):330-7. doi: 10.1093/ejo/cju052. Epub 2014 Oct 8.'}, {'pmid': '10565094', 'type': 'BACKGROUND', 'citation': 'Caldwell S, Cook P. Predicting the outcome of twin block functional appliance treatment: a prospective study. Eur J Orthod. 1999 Oct;21(5):533-9. doi: 10.1093/ejo/21.5.533.'}, {'type': 'BACKGROUND', 'citation': 'Clark William J., Mahony Derek, 2018. heal talk A journal of clinical dentistry 11.'}, {'pmid': '3422118', 'type': 'BACKGROUND', 'citation': 'Clark WJ. The twin block technique. A functional orthopedic appliance system. Am J Orthod Dentofacial Orthop. 1988 Jan;93(1):1-18. doi: 10.1016/0889-5406(88)90188-6. No abstract available.'}, {'pmid': '16679196', 'type': 'BACKGROUND', 'citation': 'Cozza P, Baccetti T, Franchi L, De Toffol L, McNamara JA Jr. Mandibular changes produced by functional appliances in Class II malocclusion: a systematic review. Am J Orthod Dentofacial Orthop. 2006 May;129(5):599.e1-12; discussion e1-6. doi: 10.1016/j.ajodo.2005.11.010.'}, {'pmid': '25052373', 'type': 'BACKGROUND', 'citation': 'Ehsani S, Nebbe B, Normando D, Lagravere MO, Flores-Mir C. Short-term treatment effects produced by the Twin-block appliance: a systematic review and meta-analysis. Eur J Orthod. 2015 Apr;37(2):170-6. doi: 10.1093/ejo/cju030. Epub 2014 Jul 22.'}, {'pmid': '29663034', 'type': 'BACKGROUND', 'citation': 'Elfeky HY, Fayed MS, Alhammadi MS, Soliman SAZ, El Boghdadi DM. Three-dimensional skeletal, dentoalveolar and temporomandibular joint changes produced by Twin Block functional appliance. J Orofac Orthop. 2018 Jul;79(4):245-258. doi: 10.1007/s00056-018-0137-1. Epub 2018 Apr 16.'}, {'pmid': '29765917', 'type': 'BACKGROUND', 'citation': 'Linjawi AI, Abbassy MA. Dentoskeletal effects of the forsus fatigue resistance device in the treatment of class II malocclusion: A systematic review and meta-analysis. J Orthod Sci. 2018 Feb 15;7:5. doi: 10.4103/jos.JOS_80_17. eCollection 2018.'}, {'pmid': '36498570', 'type': 'BACKGROUND', 'citation': 'Matthaios S, Tsolakis AI, Haidich AB, Galanis I, Tsolakis IA. Dental and Skeletal Effects of Herbst Appliance, Forsus Fatigue Resistance Device, and Class II Elastics-A Systematic Review and Meta-Analysis. J Clin Med. 2022 Nov 26;11(23):6995. doi: 10.3390/jcm11236995.'}, {'pmid': '12970656', 'type': 'BACKGROUND', 'citation': "O'Brien K, Wright J, Conboy F, Sanjie Y, Mandall N, Chadwick S, Connolly I, Cook P, Birnie D, Hammond M, Harradine N, Lewis D, McDade C, Mitchell L, Murray A, O'Neill J, Read M, Robinson S, Roberts-Harry D, Sandler J, Shaw I. Effectiveness of early orthodontic treatment with the Twin-block appliance: a multicenter, randomized, controlled trial. Part 1: Dental and skeletal effects. Am J Orthod Dentofacial Orthop. 2003 Sep;124(3):234-43; quiz 339. doi: 10.1016/S0889540603003524."}, {'pmid': '24226169', 'type': 'BACKGROUND', 'citation': "Thiruvenkatachari B, Harrison JE, Worthington HV, O'Brien KD. Orthodontic treatment for prominent upper front teeth (Class II malocclusion) in children. Cochrane Database Syst Rev. 2013 Nov 13;(11):CD003452. doi: 10.1002/14651858.CD003452.pub3."}]}, 'descriptionModule': {'briefSummary': 'Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency:\n\nA Randomized Clinical Trial', 'detailedDescription': 'The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB\n\nResearch question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency?\n\nPICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block\n\nO :\n\nPrimary outcome:\n\nOverjet\n\nSecondary outcome:\n\nSoft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance\n\nHypothesis:\n\nThere is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception.\n\n8\\. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '9 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees)\n* Overjet ≥ 5 mm\n* Growing patients (CVMS 3 or 4)\n\nExclusion Criteria:\n\n* Skeletally mature patients 15 years old or above\n* Patients with normal mandible and only protruded upper incisors.\n* Syndromic, cleft patients and patients with dental anomalies\n* Previous orthopaedic or orthodontic treatment\n* No sex predilection.'}, 'identificationModule': {'nctId': 'NCT05993156', 'briefTitle': 'Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency', 'orgStudyIdInfo': {'id': '3-3-23'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Removable twin block group', 'description': 'participants would receive conventional removable twin block for correction of class II malocclusion for 9 months', 'interventionNames': ['Device: removable twin block']}, {'type': 'EXPERIMENTAL', 'label': 'Fixed twin block group', 'description': 'participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months', 'interventionNames': ['Device: modified Fixed twinblock']}], 'interventions': [{'name': 'modified Fixed twinblock', 'type': 'DEVICE', 'otherNames': ['F.T.B.'], 'description': 'modified fixed twin block functional appliance, with cemented bands on the first molars', 'armGroupLabels': ['Fixed twin block group']}, {'name': 'removable twin block', 'type': 'DEVICE', 'otherNames': ['R.T.B.'], 'description': 'Conventional Removable Clark twin block myofunctional appliance', 'armGroupLabels': ['Removable twin block group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'ezat ahmed', 'role': 'CONTACT', 'email': 'rec@dentistry.cu.edu.eg', 'phone': '0020223642705'}], 'facility': 'Faculty of Dentistry', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'results and statistical data would be published and IPD would be available upon request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'primary investigator, assistant lecturer', 'investigatorFullName': 'Omar yousry mahmoud mostafa', 'investigatorAffiliation': 'Cairo University'}}}}