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Not yet recruiting NCT06589206

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance

No phase Interventional Growth Modification

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: modified design of twin block.
Who it may be relevant to
Registry conditions: Growth Modification. Basic parameters: 10 years — 14 years · Male.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Three-Dimensional Assessment of Dentoskeletal Changes Associated With a Modified Twin Block Appliance for Treatment of Skeletal Class II Growing Patients With Mandibular Deficiency: A Randomized Clinical Trial

Overview

The aim of the current study is to evaluate the skeletal, dental, soft tissue, TMJ, and upper airway size changes associated with a new design of twin block compared to the conventional twin block appliance. Additionally, patients' satisfaction with the two designs will be assessed.

Detailed description

Twin block appliance is the gold standard for the treatment of skeletal class II patients with deficient mandible. Yet, it has some drawbacks as proclination of the mandibular incisors, development of posterior open bite and the unesthetic appearance. Many modifications in twin block A new design were made to overcome the previous problems, as adding incisor capping, Clasps, sagittal blocks, and esthetic twin block appliances. In the current trial A new design of esthetic twin block appliance with sagittal blocks is investigated and the post treatment skeletal, dental, and soft tissue, TMJ, and upper airway size will be assessed and compared to the changes associated with the conventional design of twin block. Moreover, patient satisfaction with the appliance will be assessed with both appliances.

Interventions

  • Other modified design of twin block
    Vacuum formed twin block appliance with sagittal blocks

Primary outcome measures

  • skeletal changes [Time frame: 9 months]
  • Dental changes [Time frame: 9 months]
Secondary outcome measures (4)
  • soft tissue changes [Time frame: 9 months]
  • JMJ changes [Time frame: 9 months]
  • Upper airway size [Time frame: 9 months]
  • patient satisfaction [Time frame: after one and nine months]

Eligibility criteria

Inclusion criteria

  • skeletal class II deficient mandible
  • Class II molar and canine relation
  • male growing patients CVM 2,3 age range 10-14
  • normal vertical growth pattern
  • ANB > 4
  • mild to moderate crowding

Exclusion criteria

  • Previous orthodontic treatment.
  • Craniofacial syndrome.
  • Periodontal disease.
  • Extracted first permanent molars.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06589206 · 3444

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗