Clinical trial NCT05993156: Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency
Official title: Effects of Modified Fixed Twin Block Versus Removable Twin Block on Skeletal Class 2 Growing Patients With Mandibular Deficiency
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Malocclusion
Angle Class II
Mandible Small
Keywords: orthodontics
orthopedics
myofunctional appliance
Twinblock
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2023-08-15
Enrollment: 24
Sex: FEMALE
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Clinical Trial Parallel group, two arm, equivalent trial with 1:1 allocation ratio.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Over jet reduction
timeFrame: 9 months
Secondary outcomes:
measure: Effective mandibular length
timeFrame: 9 months
measure: lower incisor inclination
timeFrame: 9 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Faculty of Dentistry
Study officials:
References:
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