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

Cairo University (CU)

Status: Enrolling

Conditions: Mandible Small; Angle Class II; Malocclusion

Treatments: Device: modified Fixed twinblock; Device: removable twin block

Study type: Interventional

Funder types: Other

Identifiers

NCT05993156

3-3-23

Details and patient eligibility

About

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

A Randomized Clinical Trial

Full 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.

Enrollment: 24 estimated patients

Sex: Female

Ages: 9 to 15 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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24 participants in 2 patient groups

Removable twin block group

Active Comparator group

Description:

participants would receive conventional removable twin block for correction of class II malocclusion for 9 months

Treatment:

Device: removable twin block

Fixed twin block group

Experimental group

Description:

participants would receive a modified fixed twin block for correction of class II malocclusion for 9 months

Treatment:

Device: modified Fixed twinblock