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

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

Study Overview

• Status: Unknown
• Conditions: Mandibular Hypoplasia; Mandibular Retrognathism
• Intervention / Treatment: Device: Twin Block Appliance set to maximum bite; Device: Modified Twin Block

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Khaled M. Hussein, B.D.S; Phone Number: +201558332038; Email: Khaled.ali@dentistry.edu.eg
• Study Contact Backup: Name: Sahar Taher, PhD; Email: Staher@yahoo.com

Study Locations

• Egypt
  • Cairo, Egypt
    • Faculty of Dentistry, Cairo University
    • Contact: Sahar Taher, PhD; Email: Staher@yahoo.com
    • Contact: Khaled M. Hussein, B.D.S; Phone Number: +201558332038; Email: Khaled.ali@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years to 13 years (CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
ACTIVE_COMPARATOR: Maximum Bite Advancement	Device: Twin Block Appliance set to maximum bite; a traditional twin block set to maximum bite advancement at start of treatment
EXPERIMENTAL: Incremental Bite Advancement	Device: Modified Twin Block; a modified twin block design including jack screws to facilitate incemental advancement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To asses Skeletal and dentoalveolar changes in Mandible	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)	8 Months
To asses patient compliance	patient will answer a questionnaire at end of treatment	8 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To asses Skeletal and dentoalveolar changes in Maxilla	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)	8 months

Collaborators and Investigators

• Sponsor: Cairo University

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 15, 2020
• Primary Completion (ANTICIPATED): September 15, 2021
• Study Completion (ANTICIPATED): September 15, 2021

Study Registration Dates

• First Submitted: September 8, 2020
• First Submitted That Met QC Criteria: September 18, 2020
• First Posted (ACTUAL): September 24, 2020

Study Record Updates

• Last Update Posted (ACTUAL): September 24, 2020
• Last Update Submitted That Met QC Criteria: September 18, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Twin Block; Bite Advancement; Growth Modification
• Additional Relevant MeSH Terms: Congenital Abnormalities; Musculoskeletal Diseases; Stomatognathic Diseases; Stomatognathic System Abnormalities; Jaw Abnormalities; Jaw Diseases; Maxillofacial Abnormalities; Craniofacial Abnormalities; Musculoskeletal Abnormalities; Mandibular Diseases; Retrognathia; Micrognathism
• Other Study ID Numbers: CEBD-CU-2020-09-08

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no plan to share data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No