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

January 25, 2026 updated by: Haner Direskeneli, Marmara University
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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
26

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months
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.
Up to 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Marmara University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 23, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 6, 2025

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 2, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 25, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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