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

NCT07382011 | Completed

• 1 other identifier: MarmaraLM
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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.

Conditions

Myofunctional Therapy; Orthodontic Appliance; Malocclusion Class II

Keywords

Myofunctional therapy; LM-Activator™; Cervical posture; Twin block appliance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (12)

• Change in ANB Angle (degrees) Assessed by Cephalometric Analysis

  Up to 12 months

• Change in Overbite (mm) Assessed by Cephalometric Analysis

  Up to 12 months

• Change in SNA Angle (degrees) Assessed by Cephalometric Analysis

  Up to 12 months

• Change in SNB Angle (degrees) Assessed by Cephalometric Analysis

  Up to 12 months

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

  Up to 12 months

Study Arms (2)

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.

Device: LM-Activator™

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.

Device: Twin Block Appliance

Interventions

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.

LM-Activator™ Therapy Group

Twin Block Appliance DEVICE

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

Twin Block Appliance Group

Eligibility Criteria

• Age: 8 Years - 13 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marmara University: lead

Study Sites (1)

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

Istanbul, 34854, Turkey (Türkiye)

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: December 6, 2025
• First Posted: February 2, 2026
• Study Start: December 23, 2023
• Primary Completion: September 30, 2025
• Study Completion: September 30, 2025
• Last Updated: February 2, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will share

Locations

TU (1)