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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06589206
Enrollment
30
Registered
2024-09-19
Start date
2024-10-01
Completion date
2025-10-30
Last updated
2024-09-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Growth Modification

Keywords

twin block, esthetic twin block, clear twin block, Deficient mandible, Skeletal Class II

Brief summary

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

OTHERmodified design of twin block

Vacuum formed twin block appliance with sagittal blocks

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
10 Years to 14 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
skeletal changes9 monthschanges in SNA, SNB, and ANB angles will be measured before and after treatment
Dental changes9 monthschanges in maxillary and mandibular incisors position and inclination will be assessed before and after treatment

Secondary

MeasureTime frameDescription
soft tissue changes9 monthschanges in soft tissue A, B, Pog points will be assessed before and after treatment
JMJ changes9 monthschanges in the TMJ morphologic structure will be assessed before and after treatment
Upper airway size9 monthschanges in the Upper airway size will be assessed before and after treatment
patient satisfactionafter one and nine monthspatients acceptance of the appliance will be assessed by a questionnaire administered in one to one interview.

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026