Malocclusion Class II, Myofunctional Therapy, Orthodontic Appliance
Conditions
Keywords
Myofunctional therapy, LM-Activator™, Cervical posture, Twin block appliance
Brief summary
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.
Interventions
DEVICELM-Activator™
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.
DEVICETwin Block Appliance
Twin Block is a removable functional appliance commonly used in the management of Class II malocclusion in children.
Sponsors
Marmara University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
8 Years to 13 Years
Healthy volunteers
No
Inclusion criteria
* Healthy children aged 8-13 years * Cooperative behavior rated as "positive" or "definitely positive" according to the Frankl Behavior Rating Scale * Presence of Class II malocclusion * Patient-reported complaint of protruding anterior teeth * Provision of written informed consent by both the child and their parent/legal guardian
Exclusion criteria
* Inability to continue treatment in the dental chair due to lack of cooperation * Failure to attend scheduled follow-up appointments or withdrawal of consent during the study * Occurrence of treatment-related complications preventing continuation of therapy (e.g., inability to maintain cooperation between patient and clinician) * Inability to attend regular follow-up sessions or repeated absence from scheduled visits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Overjet (mm) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in ANB Angle (degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Overbite (mm) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in SNA Angle (degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in SNB Angle (degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Upper Incisor Inclination (U1-SN, degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Lower Incisor Inclination (IMPA, degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Mandibular Plane Angle (Go-Me to SN, degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Frankfort-Mandibular Plane Angle (FMA, degrees) Assessed by Cephalometric Analysis | Up to 12 months | FMA measured in degrees on standardized lateral cephalometric radiographs to assess vertical skeletal pattern. Change calculated from baseline to post-treatment. |
| Change in Jarabak Ratio (%) Assessed by Cephalometric Analysis | Up to 12 months | Jarabak ratio calculated as a percentage from standardized lateral cephalometric radiographs to assess vertical facial proportions. Change calculated from baseline to post-treatment. |
| Change in Cranio-Cervical Angle (NSL-CVT, degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Cranio-Cervical Angle (NSL-OPT, degrees) Assessed by Cephalometric Analysis | Up to 12 months | 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. |
| Change in Inner Angle (degrees) Measured on Digital Dental Models | Up to 12 months | Inner angle measured in degrees on digital dental models as defined in the study protocol. Change calculated from baseline to post-treatment. |
Countries
Turkey (Türkiye)
Outcome results
None listed