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Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05993156
Enrollment
24
Registered
2023-08-15
Start date
2022-12-01
Completion date
2023-10-30
Last updated
2023-08-15

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

Conditions

Angle Class II, Malocclusion, Mandible Small

Keywords

orthodontics, orthopedics, myofunctional appliance, Twinblock

Brief summary

Effects of modified fixed twin block versus removable twin block on skeletal class 2 growing patients with mandibular deficiency: A Randomized Clinical Trial

Detailed description

The main objective of the study is to evaluate the effects of the modified fixed TB on class 2 growing cases and to compare its effect to the conventional removable TB Research question Does the modified fixed twin block have the same effects as removable twin block during treatment of skeletal class 2 growing patients with mandibular deficiency? PICO P: Growing skeletal class 2 patients with deficient mandible I : Modified Fixed Twin block C: Conventional removable Twin block O : Primary outcome: Overjet Secondary outcome: Soft tissue Profile Antro-posterior mandibular position Mandibular length Antro-posterior maxillary position Upper and lower Incisors inclinations Durability of the appliance Patient Acceptance Hypothesis: There is no difference between the modified fixed or removable Twin block appliance regarding overjet reduction, dentoskeletal effects and patient perception. 8\. Trial design: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Interventions

DEVICEmodified Fixed twinblock

modified fixed twin block functional appliance, with cemented bands on the first molars

Conventional Removable Clark twin block myofunctional appliance

Sponsors

Cairo University
Lead SponsorOTHER

Study design

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

Intervention model description

Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.

Eligibility

Sex/Gender
FEMALE
Age
9 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* Skeletal Class 2 malocclusion cases (ANB ≥ 5 degrees) * Overjet ≥ 5 mm * Growing patients (CVMS 3 or 4)

Exclusion criteria

* Skeletally mature patients 15 years old or above * Patients with normal mandible and only protruded upper incisors. * Syndromic, cleft patients and patients with dental anomalies * Previous orthopaedic or orthodontic treatment * No sex predilection.

Design outcomes

Primary

MeasureTime frameDescription
Over jet reduction9 monthsthe horizontal distance between upper and lower incisors

Secondary

MeasureTime frameDescription
Effective mandibular length9 monthsdistance from condylon to the Pogonion points
lower incisor inclination9 monthsinclination of lower incisors on the mandibular plane

Countries

Egypt

Outcome results

None listed

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