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

Primary Purpose

Mandibular Retrognathism, Mandibular Hypoplasia

Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Modified Twin Block
Twin Block Appliance set to maximum bite
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Mandibular Retrognathism focused on measuring Twin Block, Bite Advancement, Growth Modification

Eligibility Criteria

9 Years - 13 Years (Child)FemaleDoes not accept 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

Sites / Locations

  • Faculty of Dentistry, Cairo University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Maximum Bite Advancement

Incremental Bite Advancement

Arm Description

Outcomes

Primary Outcome Measures

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)
To asses patient compliance
patient will answer a questionnaire at end of treatment

Secondary Outcome Measures

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)

Full Information

First Posted
September 8, 2020
Last Updated
September 18, 2020
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04562545
Brief Title
Twin Block Appliance in Incremental Versus Maximum Bite Advancement in Skeletal Class II
Official Title
Effect of Incremental Versus Maximum Bite Advancement in Class II Subjects Using Twin Block Appliance : Randomized Clinical Trials
Study Type
Interventional

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Unknown status
Study Start Date
September 15, 2020 (Anticipated)
Primary Completion Date
September 15, 2021 (Anticipated)
Study Completion Date
September 15, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mandibular Retrognathism, Mandibular Hypoplasia
Keywords
Twin Block, Bite Advancement, Growth Modification

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
Masking
Outcomes Assessor
Masking Description
Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Maximum Bite Advancement
Arm Type
Active Comparator
Arm Title
Incremental Bite Advancement
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Modified Twin Block
Intervention Description
a modified twin block design including jack screws to facilitate incemental advancement
Intervention Type
Device
Intervention Name(s)
Twin Block Appliance set to maximum bite
Intervention Description
a traditional twin block set to maximum bite advancement at start of treatment
Primary Outcome Measure Information:
Title
To asses Skeletal and dentoalveolar changes in Mandible
Description
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)
Time Frame
8 Months
Title
To asses patient compliance
Description
patient will answer a questionnaire at end of treatment
Time Frame
8 months
Secondary Outcome Measure Information:
Title
To asses Skeletal and dentoalveolar changes in Maxilla
Description
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)
Time Frame
8 months

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
biological growing female
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Khaled M. Hussein, B.D.S
Phone
+201558332038
Email
Khaled.ali@dentistry.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Sahar Taher, PhD
Email
Staher@yahoo.com
Facility Information:
Facility Name
Faculty of Dentistry, Cairo University
City
Cairo
Country
Egypt
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Khaled M. Hussein, B.D.S
Phone
+201558332038
Email
Khaled.ali@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name & Degree
Sahar Taher, PhD
Email
Staher@yahoo.com

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
no plan to share data
Citations:
PubMed Identifier
2773861
Citation
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.
Results Reference
background
PubMed Identifier
15520691
Citation
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.
Results Reference
background

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

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