Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design

Not Applicable

Completed

• Conditions: Skeletal Malocclusion
• Interventions: Device: Clear Mandibular Advancement Appliance

• Registration Number: NCT03824574
• Lead Sponsor: Ain Shams University

Brief Summary

This study evaluates the cephalometric effects of a clear mandibular advancement appliance for the treatment of skeletal class II growing patients suffering from mandibular deficiency.

Detailed Description

A Clear mandibular advancement appliance is constructed comprised of a clear dental splint of 1.5 mm thickness adapted on the patient's teeth. This is followed by the construction of acrylic bite ramps bonded over the splints. The bite ramps are constructed as such when the patient bites into occlusion, he/she has to advance the mandible to bring the two parts of the appliance together. Lateral cephalometric radiographs were obtained pre and post-treatment to evaluate the effects on the patient's maxilla, mandible and dentition.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-09-20
• Primary Completion: 2017-12-15
• Study Completion: 2018-03-04
• Status Verified: 2019-01
• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-01-29
• Last Update Submitted: 2019-01-29
• Study First Posted: 2019-01-31
• Last Update Posted: 2019-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 20

Inclusion Criteria

1. Gender: Female subjects.

2. Chronological age: All recruited subjects were between the ages of 8-12 years.

3. Anteroposterior skeletal relationship: Subjects with skeletal Class II malocclusion with normal maxilla and retrognathic mandible were selected. This was confirmed using lateral cephalometric radiographic analysis with the following parameters: decreased effective mandibular length (Co-Gn) according to McNamara composite , SNB<78, SNA=82+2.

4. Dental characteristics:

   • Angle Class II molar relationship ranging from edge to edge to full unit Class II.
   • Overjet ranging between 5-10 mm.
   • Absence of posterior crossbite and/or tendency for posterior crossbite.

5. Skeletal maturation stage: The growth stage for all subjects was selected to be before or at the prepubertal growth spurt. This was confirmed by cervical vertebral maturation analysis from the lateral cephalometric radiograph. The cervical vertebrae maturation stage required was Cervical Vertebrae Maturation stage 2-3 according to the cervical vertebrae maturation index by Baccetti et al. allowing sufficient time before the end of the growth spurt.

6. No previous history of orthodontic treatment.

7. Absence of systemic diseases affecting growth or craniofacial development. -

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Exclusion Criteria

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment arm	Clear Mandibular Advancement Appliance	Subjects receiving the clear mandibular advancement appliance

Primary Outcome Measures

Name	Time	Method
Effective maxillary length	12 months	Condylion-A point
Maxilla to cranial base	12 months	Sella-Nasion-A point
Effective Mandibular Length	12 months	Condylion-Gnathion
Mandible to cranial base	12 months	Sella-Nasion-B point

Secondary Outcome Measures

Name	Time	Method
Chin position	12 months	Soft tissue Pogonion position
Lower incisor AP position	12 months	Lower incisor Anteroposterior position
Profile convexity	12 months	N'Sn/Sn-Pog'
Lip protrusion	12 months	Ls-E plane
Lower incisor inclination	12 months	Lower incisor to mandibular plane
Upper incisor inclination	12 months	Upper incisor to palatal plane
Upper incisor AP position	12 months	Upper incisor Anteroposterior position