The Use of an Esthetic Twin Block for Patients With Mandibular Retrusion

Damascus University

Status: Completed

Conditions: Class II Malocclusion

Treatments: Device: ETB; Device: CTB

Study type: Interventional

Funder types: Other

Identifiers

NCT05418413

UDDS-Ortho-12-2022

Details and patient eligibility

About

This experimental study will evaluate the effect of an esthetic Twin-block appliance on the correction of class II malocclusion compared with the traditional Twin-block appliance.

The study sample will consist of 50 patients with class II malocclusion. The sample will be allocated randomly into two groups: the control group and the experimental group.

The traditional Twin-block appliance will be applied for the control group patients, while the esthetic Twin-block appliance will be applied for the experimental group patients. The dentoskeletal, soft tissue changes and esthetic and functional efficacy occurring after functional treatment will be assessed using cephalometric radiographs and profile photographs, pre and post-treatment, and a questionnaire. Changes for each group will be evaluated individually, and the two groups will be compared.

Full description

Class II malocclusion is one of the most frequent orthodontic problems, and most class II malocclusion cases are the result of mandibular deficiency. Twin block (TB) is one of the most popular functional appliances to treat this condition. Despite excellent treatment results with TB, its acceptance and compliance may be hampered by its wiry structure and appearance. Furthermore, it has a side effect of causing the proclination of lower incisors, which reduces skeletal change. Various modifications were proposed to reduce lower incisors proclination but had no significant effect. Patient cooperation is one of the most important factors for successful functional appliance treatment, and it depends upon comfort and esthetic acceptability, which ensures good patient compliance. so, in order to enhance the esthetic appearance and overcome the disadvantages of a conventional Twin-Block (CTB), a novel esthetic Twin-Block (ETB) was fabricated from a specific material using a pressure molding device and acrylic bite blocks. There is only one study that evaluated this appliance which is a pilot study that compared the treatment effects of the (ETB) and (CTB) in the treatment of Class II malocclusions. However, this study has a lot of limitations, making it difficult to evaluate this appliance's efficiency accurately. The aim of this study is to study the dento-skeletal, soft tissue changes, and esthetic and functional efficacy that result from treatment by this appliance (ETB) and to compare them to the changes in the matched group will be treated with (CTB), by studying the cephalometric radiographs, profile photographs, and a questionnaire.

Enrollment: 50 patients

Sex: All

Ages: 11 to 14 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Angle class II malocclusion because of mandibular retrognathia
• O.J > 5 , SNB < 78
• Patient during growth spurt
• Normal or horizontal growth pattern Björk > 402

Exclusion criteria

• TMJ disorders
• Poor oral hygiene
• Previous orthodontic treatment.
• Patients with syndromes, clefts, or craniofacial abnormalities.
• Reason of contraindication of functional treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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50 participants in 2 patient groups

Conventional Twin-block appliance

Active Comparator group

Description:

The patients in this control group will be treated using the conventional Twin-block appliance (CTB).

Treatment:

Device: CTB

Esthetic Twin-block appliance

Experimental group

Description:

the patients in this experimental group will be treated using the esthetic Twin-block appliance (ETB).

Treatment:

Device: ETB