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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03824574
Enrollment
20
Registered
2019-01-31
Start date
2016-09-20
Completion date
2018-03-04
Last updated
2019-01-31

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

Conditions

Skeletal Malocclusion

Keywords

Functional appliance, skeletal class II, mandibular deficiency, twin-block, Growing patients, Clear appliance, Aligner

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.

Interventions

DEVICEClear Mandibular Advancement Appliance

Clear Mandibular Advancement Appliance for treatment of skeletal class II patients with retrognathic mandible

Sponsors

Ain Shams University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
8 Years to 12 Years
Healthy volunteers
No

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. -

Exclusion criteria

\-

Design outcomes

Primary

MeasureTime frameDescription
Effective Mandibular Length12 monthsCondylion-Gnathion
Mandible to cranial base12 monthsSella-Nasion-B point
Effective maxillary length12 monthsCondylion-A point
Maxilla to cranial base12 monthsSella-Nasion-A point

Secondary

MeasureTime frameDescription
Profile convexity12 monthsN'Sn/Sn-Pog'
Lower incisor inclination12 monthsLower incisor to mandibular plane
Chin position12 monthsSoft tissue Pogonion position
Lip protrusion12 monthsLs-E plane
Lower incisor AP position12 monthsLower incisor Anteroposterior position
Upper incisor inclination12 monthsUpper incisor to palatal plane
Upper incisor AP position12 monthsUpper incisor Anteroposterior position

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026