NCT04562545

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 8, 2020

Completed
7 days until next milestone

Study Start

First participant enrolled

September 15, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

September 24, 2020

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 15, 2021

Completed
Last Updated

September 24, 2020

Status Verified

September 1, 2020

Enrollment Period

1 year

First QC Date

September 8, 2020

Last Update Submit

September 18, 2020

Conditions

Mandibular RetrognathismMandibular Hypoplasia

Keywords

Twin BlockBite AdvancementGrowth Modification

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (1)

  • To asses Skeletal and dentoalveolar changes in Maxilla

    8 months

Study Arms (2)

Maximum Bite Advancement

ACTIVE COMPARATOR
Device: Twin Block Appliance set to maximum bite

Incremental Bite Advancement

EXPERIMENTAL
Device: Modified Twin Block

Interventions

Modified Twin BlockDEVICE

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

Incremental Bite Advancement
Twin Block Appliance set to maximum biteDEVICE

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

Maximum Bite Advancement

Eligibility Criteria

Age9 Years - 13 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsbiological growing female
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Cairo University

Cairo, Egypt

Location

Related Publications (2)

  • 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: 2773861BACKGROUND

  • 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: 15520691BACKGROUND

MeSH Terms

Conditions

Micrognathism

Condition Hierarchy (Ancestors)

Jaw AbnormalitiesJaw DiseasesMusculoskeletal DiseasesMaxillofacial AbnormalitiesCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesStomatognathic DiseasesStomatognathic System AbnormalitiesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Central Study Contacts

Khaled M. Hussein, B.D.S

CONTACT

+201558332038Khaled.ali@dentistry.edu.eg

Sahar Taher, PhD

CONTACT

Staher@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Assessor will carry out measurements blindly on pre-operative and post-operative radio-graphs
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Type: Two arm, parallel, randomized clinical trial. allocation ratio 1:1 framework: superiority
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Post Graduate Student, Department of Orthodontics, Cairo University

Study Record Dates

First Submitted

September 8, 2020

First Posted

September 24, 2020

Study Start

September 15, 2020

Primary Completion

September 15, 2021

Study Completion

September 15, 2021

Last Updated

September 24, 2020

Record last verified: 2020-09

Data Sharing

IPD Sharing
Will not share

no plan to share data

Locations

EG(1)