Myofunctional TherapyNCT07382011
Assessment of Craniofacial and Postural Changes Induced by LM-Activator Therapy in Growing Children
A study testing LM-Activator™ and Twin Block Appliance in people with Myofunctional Therapy and Orthodontic Appliance, run by Marmara University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 8 to 13 years
- Conditions the study is for
- Myofunctional Therapy, Orthodontic Appliance, Malocclusion Class II
- What is being tested?
- LM-Activator™ and Twin Block Appliance
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2023to 30 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 13 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Marmara Üniversitesi Recep Tayyip Erdoğan Külliyesi Sağlık Yerleşkesi, Diş Hekimliği Fakültesi, Başıbüyük Yolu 9/3 34854 Başıbüyük / Maltepe / İSTANBUL
Istanbul, 34854
About this study
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.
- Being tested
- LM-Activator™, Twin Block Appliance
- Keywords
- Myofunctional therapy, LM-Activator™, Cervical posture, Twin block appliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Twin Block Appliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 12 months
Secondary outcomes (12)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Up to 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start23 Dec 2023
- Primary completion30 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myofunctional TherapyStudies of the same condition, open and under way.
- More trials run by Marmara UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Marmara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haner Direskeneli, Marmara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07382011
- Sponsor's protocol ID
- MarmaraLM
- Status last verified
- Jan 2026
- First submitted
- 6 Dec 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Craniofacial and Postural Changes Induced by LM-Activator Therapy in Growing Children
- ClinicalTrials.gov ID
- NCT07382011
- Acronym / sponsor ID
- MarmaraLM
- Keywords
- Myofunctional therapy, LM-Activator™, Cervical posture, Twin block appliance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Marmara UniversityUniversity, hospital or other
- Study start
- 23 Dec 2023 (actual)
- Primary completion
- 30 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 2 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| LM-Activator™ Therapy Group | Experimental | Device: LM-Activator™Children aged 8-13 years with Class II malocclusion received LM-Activator™ treatment. Skeletal, dentoalveolar, and cervical posture changes were evaluated prospectively. |
| Twin Block Appliance Group | Active comparator | Device: Twin Block ApplianceChildren aged 8-13 years with Class II malocclusion treated with Twin Block appliances (archived records). Outcomes were analyzed for comparison with the experimental group. |
Who may qualify
- Ages
- 8 to 13 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | LM-Activator™ Therapy Group |
| Twin Block ApplianceTwin Block is a removable functional appliance commonly used in the management of Class II malocclusion in children. | Device | Twin Block Appliance Group |
Primary outcome
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.
12 secondary outcomes
Change in ANB Angle (degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Overbite (mm) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in SNA Angle (degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in SNB Angle (degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Upper Incisor Inclination (U1-SN, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Lower Incisor Inclination (IMPA, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Mandibular Plane Angle (Go-Me to SN, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Frankfort-Mandibular Plane Angle (FMA, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Jarabak Ratio (%) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Cranio-Cervical Angle (NSL-CVT, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Cranio-Cervical Angle (NSL-OPT, degrees) Assessed by Cephalometric Analysis
Time frame: Up to 12 months
Change in Inner Angle (degrees) Measured on Digital Dental Models
Time frame: Up to 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes. 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.
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Myofunctional Therapy for Children With OSA
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Not yet recruiting
Effects of Orofacial Myofunctional Therapy and Cervical Stabilization Exercises in Patients With Axis-i Group Iia Temporomandibular Dysfunction
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LM-Activator™ and Twin Block Appliance in people with Myofunctional Therapy and Orthodontic Appliance, run by Marmara University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Overjet (mm) Assessed by Cephalometric Analysis (time frame: Up to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.