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

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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04562545

Enrollment

Registered

2020-09-24

Start date

2020-09-15

Completion date

2021-09-15

Last updated

2020-09-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mandibular Hypoplasia, Mandibular Retrognathism

Keywords

Twin Block, Bite Advancement, Growth Modification

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.

Interventions

DEVICEModified Twin Block

a modified twin block design including jack screws to facilitate incemental advancement

DEVICETwin Block Appliance set to maximum bite

a traditional twin block set to maximum bite advancement at start of treatment

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs

Intervention model description

Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority

Eligibility

Sex/Gender

FEMALE

Age

9 Years to 13 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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)

Countries

Egypt

Contacts

Primary ContactKhaled M. Hussein, B.D.S

Khaled.ali@dentistry.edu.eg+201558332038

Backup ContactSahar Taher, PhD

Staher@yahoo.com

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026