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Completed

NCT Number: NCT07382011

Assessment of Craniofacial and Postural Changes Induced by LM-Activator Therapy in Growing Children

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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Key information

Conditions

Myofunctional Therapy Malocclusion Class II Orthodontic Appliance

Age range

8 year–13 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL

Istanbul, 34854, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Twin block appliance

Device

Twin Block is a removable functional appliance commonly used in the management of Class II malocclusion in children.

Primary outcomes

  1. Change in Overjet (mm) Assessed by Cephalometric Analysis

    Time frame: 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 outcomes

  1. Change in ANB Angle (degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  2. Change in Overbite (mm) Assessed by Cephalometric Analysis

    Time frame: 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.

  3. Change in SNA Angle (degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  4. Change in SNB Angle (degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  5. Change in Upper Incisor Inclination (U1-SN, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  6. Change in Lower Incisor Inclination (IMPA, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  7. Change in Mandibular Plane Angle (Go-Me to SN, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  8. Change in Frankfort-Mandibular Plane Angle (FMA, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  9. Change in Jarabak Ratio (%) Assessed by Cephalometric Analysis

    Time frame: 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.

  10. Change in Cranio-Cervical Angle (NSL-CVT, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  11. Change in Cranio-Cervical Angle (NSL-OPT, degrees) Assessed by Cephalometric Analysis

    Time frame: 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.

  12. Change in Inner Angle (degrees) Measured on Digital Dental Models

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Marmara University

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Feb 2, 2026
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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