Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II

NCT04562545 — Not applicable, Unknown, 24 participants, Cairo University

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Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials

Registry	NCT04562545
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	24 (Estimated)
Sponsor	Cairo University (Other)
Conditions	Mandibular Retrognathism, Mandibular Hypoplasia
Interventions	Modified Twin Block, Twin Block Appliance set to maximum bite (Device)
Dates	start 2020-09-15 (estimated), primary completion 2021-09-15 (estimated), completion 2021-09-15 (estimated), first posted 2020-09-24, last updated 2020-09-24
Locations	1 site in Egypt

-Summary

The aim of this study is to compare to different protocols to treat Class II malocclusion in growing subjects using the twin block appliance

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+Detailed description

* Patients will be clinically and radio-graphically examined for eligibility
* Eligible patients will be randomly assigned to one of two groups:

* Control Group: Twin Block Appliance fabricated to Maximum Bite Advancement group
* Intervention Group: Twin Block Appliance fabricated for Incremental Bite Advancement group
* Records will be taken and impressions will be made and poured. In the control group, bite registration will be made with maximum mandibular advancement. In the intervention group, bite registration is made to habitual bite to make a modified twin block.
* Patients will be recalled every 6 weeks for 8 months for monitoring and reactivation of the appliance.

+Arms and interventions

Arm	Type	Interventions	Description
Maximum Bite Advancement	Active comparator	Device: Twin Block Appliance set to maximum bite
Incremental Bite Advancement	Experimental	Device: Modified Twin Block

Modified Twin Block (Device): a modified twin block design including jack screws to facilitate incemental advancement
Twin Block Appliance set to maximum bite (Device): a traditional twin block set to maximum bite advancement at start of treatment

+Outcome measures

Primary outcomes

To asses Skeletal and dentoalveolar changes in Mandible [8 Months]: Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in mandible. \- changes that will be assesed include ( mandibular base length / mandibular antero posterior position in relation to cranial base/ Condylar position / lower incisor inclination to mandibular plane)
To asses patient compliance [8 months]: patient will answer a questionnaire at end of treatment

Secondary outcomes

To asses Skeletal and dentoalveolar changes in Maxilla [8 months]: * Cone Beam CT will be taken before and after active treatment, 3D Cephalometric analysis will be conducted on the Cone Beam to asses Skeletal and Dentoalvoelar changes in maxilla * Changes that will be assesed include ( maxillary base length / maxillary base antero posterior position in relation to cranial base / incisor inclination to palatial plane)

+Eligibility

Sex: Female, ages: 9 Years to 13 Years

Inclusion Criteria:

* Growing Female Patient
* Skeletal Class II Malocclusion due to deficient mandible
* Overjet of 7 to 10 mm
* Short or normal vertical facial pattern
* No previous orthodontic nor orthopedic treatment

Exclusion Criteria:

* Syndromes or Chronic Illness
* Skeletal Class II Malocclusion due to excessive maxilla
* Vertical skeletal growth pattern
* Habits

+Locations (1)

Facility	City	Country	Status
Faculty of Dentistry, Cairo University	Cairo	Egypt

+Publications

DeVincenzo JP, Winn MW. Orthopedic and orthodontic effects resulting from the use of a functional appliance with different amounts of protrusive activation. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):181-90. doi: 10.1016/0889-5406(89)90454-x. PMID 2773861
Banks P, Wright J, O'Brien K. Incremental versus maximum bite advancement during twin-block therapy: a randomized controlled clinical trial. Am J Orthod Dentofacial Orthop. 2004 Nov;126(5):583-8. doi: 10.1016/j.ajodo.2004.03.024. PMID 15520691