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.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance; Myofunctional Therapy; Malocclusion Class II
• Intervention / Treatment: Device: LM-Activator™; Device: Twin Block Appliance

• Study Type: Interventional
• Enrollment (Actual): 26
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34854
    • Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: LM-Activator™ Therapy Group; Children aged 8-13 years with Class II malocclusion received LM-Activator™ treatment. Skeletal, dentoalveolar, and cervical posture changes were evaluated prospectively.	Device: LM-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.
Active Comparator: Twin Block Appliance Group; 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.	Device: Twin Block Appliance; Twin Block is a removable functional appliance commonly used in the management of Class II malocclusion in children.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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
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

Collaborators and Investigators

• Sponsor: Marmara University

Study record dates

Study Major Dates

• Study Start (Actual): December 23, 2023
• Primary Completion (Actual): September 30, 2025
• Study Completion (Actual): September 30, 2025

Study Registration Dates

• First Submitted: December 6, 2025
• First Submitted That Met QC Criteria: January 25, 2026
• First Posted (Actual): February 2, 2026

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 25, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Twin block appliance; Myofunctional therapy; LM-Activator™; Cervical posture
• Other Study ID Numbers: MarmaraLM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No