Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency
NCT ID: NCT05993156
Last Updated: 2023-08-15
Study Results
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Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2022-12-01
2023-10-30
Brief Summary
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A Randomized Clinical Trial
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Detailed Description
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Research 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?
PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block
O :
Primary outcome:
Overjet
Secondary outcome:
Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance
Hypothesis:
There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception.
8\. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Removable twin block group
participants would receive conventional removable twin block for correction of class II malocclusion for 9 months
removable twin block
Conventional Removable Clark twin block myofunctional appliance
Fixed twin block group
participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months
modified Fixed twinblock
modified fixed twin block functional appliance, with cemented bands on the first molars
Interventions
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modified Fixed twinblock
modified fixed twin block functional appliance, with cemented bands on the first molars
removable twin block
Conventional Removable Clark twin block myofunctional appliance
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Overjet ≥ 5 mm
* Growing patients (CVMS 3 or 4)
Exclusion Criteria
* Patients with normal mandible and only protruded upper incisors.
* Syndromic, cleft patients and patients with dental anomalies
* Previous orthopaedic or orthodontic treatment
* No sex predilection.
9 Years
15 Years
FEMALE
No
Sponsors
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Cairo University
OTHER
Responsible Party
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Omar yousry mahmoud mostafa
primary investigator, assistant lecturer
Locations
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Faculty of Dentistry
Cairo, , Egypt
Countries
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Facility Contacts
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References
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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.
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.
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.
Clark William J., Mahony Derek, 2018. heal talk A journal of clinical dentistry 11.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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3-3-23
Identifier Type: -
Identifier Source: org_study_id
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