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

Marmara University

Status: Completed

Conditions: Orthodontic Appliance; Myofunctional Therapy; Malocclusion Class II

Treatments: Device: LM-Activator™; Device: Twin Block Appliance

Study type: Interventional

Funder types: Other

Identifiers

NCT07382011

MarmaraLM

Details and patient eligibility

About

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.

Enrollment: 26 patients

Sex: All

Ages: 8 to 13 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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26 participants in 2 patient groups

LM-Activator™ Therapy Group

Experimental group

Description:

Children aged 8-13 years with Class II malocclusion received LM-Activator™ treatment. Skeletal, dentoalveolar, and cervical posture changes were evaluated prospectively.

Treatment:

Device: LM-Activator™

Twin Block Appliance Group

Active Comparator group

Description:

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.

Treatment:

Device: Twin Block Appliance