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

Not Applicable

• Conditions: Mandibular Retrognathism; Mandibular Hypoplasia
• Interventions: Device: Twin Block Appliance set to maximum bite; Device: Modified Twin Block

• Registration Number: NCT04562545
• Lead Sponsor: Cairo University

Brief 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

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.

Study Timeline

• Status Verified: 2020-09
• Study First Submitted: 2020-09-08
• Study Start: 2020-09-15
• Study First Submitted QC: 2020-09-18
• Last Update Submitted: 2020-09-18
• Study First Posted: 2020-09-24
• Last Update Posted: 2020-09-24
• Primary Completion: 2021-09-15
• Study Completion: 2021-09-15

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Maximum Bite Advancement	Twin Block Appliance set to maximum bite	-
Incremental Bite Advancement	Modified Twin Block	-

Primary Outcome Measures

Name	Time	Method
To asses patient compliance	8 months	patient will answer a questionnaire at end of treatment
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)

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

Faculty of Dentistry, Cairo University; 🇪🇬 Cairo, Egypt