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Status unknownNCT04562545Updated Sep 24, 2020

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

An interventional study of Modified Twin Block and Twin Block Appliance set to maximum bite in Mandibular Retrognathism and Mandibular Hypoplasia, sponsored by Cairo University. Status unknown at 1 site in Egypt. Open to female participants aged 9 Years to 13 Years. Per ClinicalTrials.gov, last updated 2020-09-24.

Sponsored by Cairo University · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
24
Allocation
Randomized
Ages
9 Years to 13 Years
Sex
Female
01

Study 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

Read the 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.
02

Conditions studied

  • Mandibular Retrognathism
  • Mandibular Hypoplasia

Keywords

  • Twin Block
  • Bite Advancement
  • Growth Modification
03

Who can participate

Ages eligible
9 Years to 13 Years
Sexes eligible
Female
Accepts healthy volunteers
No

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

Exclusion Criteria:

  • Syndromes or Chronic Illness
  • Skeletal Class II Malocclusion due to excessive maxilla
  • Vertical skeletal growth pattern
  • Habits
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
24 participants (estimated)

Study arms

  • Active comparator
    Maximum Bite Advancement

    Device: Twin Block Appliance set to maximum bite

  • Experimental
    Incremental Bite Advancement

    Device: Modified Twin Block

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

05

What researchers measure

Primary outcomes

  1. 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)

    Time frame: 8 Months

  2. To asses patient compliance

    patient will answer a questionnaire at end of treatment

    Time frame: 8 months

Secondary outcomes

  1. 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)

    Time frame: 8 months

06

Study locations

1 site
07

References and documents

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. PubMed 2773861 ↗
  • 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. PubMed 15520691 ↗

Individual participant data

Plan to share: No — no plan to share data

08

Registry details

Key details

Study ID
NCT04562545
Lead sponsor
Cairo University
Responsible party
Khaled Mohamed Ali Hussein (Post Graduate Student, Department of Orthodontics, Cairo University, Cairo University) — Principal investigator
First posted
Sep 24, 2020
Start date
Sep 15, 2020 (estimated)
Primary completion
Sep 15, 2021 (estimated)
Completion
Sep 15, 2021 (estimated)
Last update
Sep 24, 2020

Study contacts

Khaled M. Hussein, B.D.S
Contact
Khaled.ali@dentistry.edu.eg
+201558332038
Sahar Taher, PhD
Contact
Staher@yahoo.com

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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