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Clinical Trials/NCT03635463
NCT03635463
Unknown
Not Applicable

Effect of Modified Twin Block in Skeletal Class II Growing Females With Mandibular Deficiency: A Randomized Controlled Trial

Cairo University0 sites30 target enrollmentDecember 2018

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Class II Division 1 Malocclusion
Sponsor
Cairo University
Enrollment
30
Primary Endpoint
enhancing mandibular skeletal growth
Last Updated
7 years ago

Overview

Brief Summary

The aim of this study is to evaluate the treatment effects of conventional twin block appliance versus modified twin block appliance in the treatment of patients in growing stage having skeletal class II division 1 with mandibular deficiency.

Detailed Description

in this randomized controlled trail there are 2 groups , the first group will receive modified twin block appliance ,in the second group will receive conventional twin block appliance . the follow up period will be 9 months till mandibular growth occur . the assessment will be through a questionnaire on the number of hours the appliance is worn each day , and another questionnaire assessing the difficulty of speech and aesthetics . Also by, photographs, x-rays and study models preoperative and post operative.

Registry
clinicaltrials.gov
Start Date
December 2018
End Date
December 2019
Last Updated
7 years ago
Study Type
Interventional
Study Design
Parallel
Sex
Female

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Heba Yehia

assistant lecturer

Cairo University

Eligibility Criteria

Inclusion Criteria

  • Skeletal Class II relationship (ANB \> 4°).
  • Mandibular retrognathy (SNB \< 78°).
  • Overjet ≥ 5 mm.
  • Minimal crowding in dental arches (≤4 mm).
  • Class II molar relation.
  • Growing female patients.
  • Patients with CMV3 maturation stage of the cervical verbrae.

Exclusion Criteria

  • No history of orthodontic treatment either prior to or during functional Appliance therapy.
  • Posterior cross bites or severe maxillary transverse deficiency.
  • Severe facial asymmetry determined by clinical or radiographical examination.
  • Poor oral hygiene.
  • Systemic diseases that may affect the orthodontic treatment results.
  • Patients past their peak growth spurt.

Outcomes

Primary Outcomes

enhancing mandibular skeletal growth

Time Frame: 9 months

it will be assessed by measuring the incremental growth by quick ceph (mm)

Secondary Outcomes

  • Improvement of soft tissue profile(9 months)
  • Patient's compliance(9 months)
  • dentoalveolar changes(9 months)

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