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

N/ACompletedNCT07382011

Marmara University26 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Myofunctional Therapy Orthodontic Appliance Malocclusion Class II

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.

Twin Block ApplianceDEVICE

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

Eligibility

Sex: ALLMin age: 8 YearsMax age: 13 Years

Medical Language ↔ Plain English

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

Locations (1)

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

Istanbul, Turkey (Türkiye)

Outcomes

Primary Outcomes

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.

Time frame: Up to 12 months

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: Up to 12 months

Data from ClinicalTrials.gov

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