Skeletal Malocclusion Clinical Trial
Official title:
Cephalometric Evaluation of a Clear Mandibular Advancement Appliance Based on the Twin-block Design
Verified date | January 2019 |
Source | Ain Shams University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 20 |
Est. completion date | March 4, 2018 |
Est. primary completion date | December 15, 2017 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 8 Years to 12 Years |
Eligibility |
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: |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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Ain Shams University |
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* Note: There are 17 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Effective Mandibular Length | Condylion-Gnathion | 12 months | |
Primary | Mandible to cranial base | Sella-Nasion-B point | 12 months | |
Primary | Effective maxillary length | Condylion-A point | 12 months | |
Primary | Maxilla to cranial base | Sella-Nasion-A point | 12 months | |
Secondary | Lower incisor inclination | Lower incisor to mandibular plane | 12 months | |
Secondary | Lower incisor AP position | Lower incisor Anteroposterior position | 12 months | |
Secondary | Upper incisor inclination | Upper incisor to palatal plane | 12 months | |
Secondary | Upper incisor AP position | Upper incisor Anteroposterior position | 12 months | |
Secondary | Profile convexity | N'Sn/Sn-Pog' | 12 months | |
Secondary | Lip protrusion | Ls-E plane | 12 months | |
Secondary | Chin position | Soft tissue Pogonion position | 12 months |
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