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This prospective study will compare the effects of LM-Activator™ and Twin Block appliances in 26 children (aged 8-13 years) with Class II malocclusion. Skeletal, dentoalveolar, and cervical posture parameters will be assessed using lateral cephalometric radiographs and digital dental models.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LM-Activator™ Therapy Group | Experimental | Children aged 8-13 years with Class II malocclusion received LM-Activator™ treatment. Skeletal, dentoalveolar, and cervical posture changes were evaluated prospectively. |
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| Twin Block Appliance Group | Active Comparator | Children aged 8-13 years with Class II malocclusion treated with Twin Block appliances (archived records). Outcomes were analyzed for comparison with the experimental group. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| LM-Activator™ | Device | The LM-Activator™ is a prefabricated myofunctional orthodontic appliance designed for early treatment of Class II malocclusion in growing children. In this study, children aged 8-13 years received LM-Activator™ therapy, and changes in skeletal, dentoalveolar, and cervical posture parameters were evaluated using cephalometric analysis and digital dental models. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Overjet (mm) Assessed by Cephalometric Analysis | Overjet defined as the horizontal distance (in millimeters) between the incisal edge of the maxillary and mandibular central incisors, measured on standardized lateral cephalometric radiographs. The outcome is calculated as the change from baseline to post-treatment. | Up to 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in ANB Angle (degrees) Assessed by Cephalometric Analysis | ANB angle measured in degrees on standardized lateral cephalometric radiographs to evaluate the sagittal skeletal relationship between the maxilla and mandible. The outcome is calculated as the change from baseline to post-treatment. | Up to 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL | Istanbul | 34854 | Turkey (Türkiye) |
De-identified individual participant data (including intraoral photographs and clinical evaluation scores) may be shared in scientific publications or presentations. Data will be limited to information relevant for scientific analysis and will not include any personal identifiers.
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| Twin Block Appliance | Device | Twin Block is a removable functional appliance commonly used in the management of Class II malocclusion in children. |
|
| Change in Overbite (mm) Assessed by Cephalometric Analysis |
Overbite defined as the vertical overlap (in millimeters) between the maxillary and mandibular central incisors, measured on standardized lateral cephalometric radiographs. Change calculated from baseline to post-treatment. |
| Up to 12 months |
| Change in SNA Angle (degrees) Assessed by Cephalometric Analysis | SNA (Sella-Nasion-A point) angle measured in degrees on standardized lateral cephalometric radiographs to evaluate sagittal position of the maxilla relative to the cranial base. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in SNB Angle (degrees) Assessed by Cephalometric Analysis | SNB (Sella-Nasion-B point) angle measured in degrees on standardized lateral cephalometric radiographs to evaluate sagittal position of the mandible relative to the cranial base. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Upper Incisor Inclination (U1-SN, degrees) Assessed by Cephalometric Analysis | U1-SN angle measured in degrees on standardized lateral cephalometric radiographs to assess maxillary incisor inclination relative to the SN plane. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Lower Incisor Inclination (IMPA, degrees) Assessed by Cephalometric Analysis | IMPA (Incisor Mandibular Plane Angle) measured in degrees on standardized lateral cephalometric radiographs to assess mandibular incisor inclination relative to the mandibular plane. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Mandibular Plane Angle (Go-Me to SN, degrees) Assessed by Cephalometric Analysis | Mandibular plane angle measured in degrees as the angle between the Go-Me line and the SN plane on standardized lateral cephalometric radiographs (vertical skeletal pattern). Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Frankfort-Mandibular Plane Angle (FMA, degrees) Assessed by Cephalometric Analysis | FMA measured in degrees on standardized lateral cephalometric radiographs to assess vertical skeletal pattern. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Jarabak Ratio (%) Assessed by Cephalometric Analysis | Jarabak ratio calculated as a percentage from standardized lateral cephalometric radiographs to assess vertical facial proportions. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Cranio-Cervical Angle (NSL-CVT, degrees) Assessed by Cephalometric Analysis | NSL-CVT angle measured in degrees on standardized lateral cephalometric radiographs to assess head and cervical posture (cranial base to cervical vertebra tangent). Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Cranio-Cervical Angle (NSL-OPT, degrees) Assessed by Cephalometric Analysis | NSL-OPT angle measured in degrees on standardized lateral cephalometric radiographs to assess head posture relative to the odontoid process tangent. Change calculated from baseline to post-treatment. | Up to 12 months |
| Change in Inner Angle (degrees) Measured on Digital Dental Models | Inner angle measured in degrees on digital dental models as defined in the study protocol. Change calculated from baseline to post-treatment. | Up to 12 months |