Hyperdivergent Facial PatternOB-MUSCLENCT06949527
Effects of Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle
A study testing Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics in people with Hyperdivergent Facial Pattern and Skeletal Open Bite, run by Murat Kaan Erdem at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Hyperdivergent Facial Pattern, Skeletal Open Bite, Hyperdivergent Growth Pattern
- What is being tested?
- Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Jan 2024to 15 Jan 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 12 to 14 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- GoGn/SN angle ≥ 36°
- Decreased overbite (dental open bite)
- In active growth phase (confirmed by hand-wrist radiograph)
- Good oral hygiene
- No prior orthodontic or orthognathic treatment
Who cannot join
- Presence of systemic disease or craniofacial deformity
- Poor oral hygiene
- Non-compliance with appliance wear
- Previous use of skeletal anchorage devices
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ankara University Faculty of Dentistry
Ankara, Çankaya, 06500
About this study
Official title: Ultrasonographic and Sonoelastographic Evaluation of the Effects of Open Bite Activator and Anterior Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle in Skeletal Open Bite Cases
This clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. A total of 24 growing individuals with increased vertical skeletal pattern were treated with a functional appliance and intermaxillary vertical elastics supported by miniscrews placed in the anterior region. Ultrasonographic and sonoelastographic assessments were performed at baseline, 6 months, and 12 months to measure changes in masseter muscle thickness and stiffness. Cephalometric radiographs were also used to evaluate dentofacial structural changes. This study aims to provide insight into the soft tissue changes associated with functional orthopedic treatment in hyperdivergent patients.
Read the detailed description
This prospective clinical study investigates the dentofacial and muscular effects of a combined orthopedic treatment method in patients with skeletal open bite. The intervention includes the use of an open bite activator appliance along with anterior skeletal anchorage-supported vertical elastics. The study was conducted at Ankara University Faculty of Dentistry, Orthodontics Department, and received ethical approval (Approval No: 36290600/78).
A total of 24 growing individuals (14 females, 10 males) with increased vertical facial pattern (GoGn/SN ≥ 36°) were treated over a 12-month period. Patients received custom-made open bite activators designed to eliminate occlusal contact in the anterior region and redirect functional forces posteriorly. Miniscrews were placed between the lateral and canine teeth in both the maxilla and mandible, and vertical elastics were applied between these skeletal anchorage points with a force of 150 grams on each side, worn for 20-22 hours daily.
Masseter muscle changes were assessed using ultrasonography and sonoelastography at three time points: baseline (T0), interim (6 months, T1), and end of treatment (12 months, T2). Muscle thickness and stiffness (elasticity) were measured bilaterally during rest and maximal clenching. Cephalometric radiographs were obtained at T0 and T2 to evaluate skeletal and dentoalveolar changes, including SNA, SNB, ANB angles, overbite, U1-PP, L1-MP, and other relevant vertical and angular measurements.
Statistical analysis revealed significant increases in masseter muscle thickness during the treatment period, especially between T0 and T1. Stiffness values peaked at T1 and slightly decreased at T2, but remained higher than baseline. Cephalometric findings showed improvements in overbite and reductions in vertical growth tendencies, including significant changes in GoGn/SN and PP-MP angles.
This study demonstrates that combined functional appliance and skeletal anchorage-based vertical control therapy can positively influence muscle structure and dentofacial morphology in hyperdivergent skeletal open bite cases. Ultrasonography and sonoelastography proved to be reliable, non-invasive methods for assessing soft tissue changes in orthodontic treatment.
- Conditions
- Hyperdivergent Facial Pattern, Skeletal Open Bite, Hyperdivergent Growth Pattern, Anterior Open Bite
- Being tested
- Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
- Keywords
- Open Bite Treatment, Masseter Muscle, Ultrasound Imaging, Sonoelastography, Skeletal Anchorage, Vertical Elastics, Functional Orthodontic Appliance, Cephalometric Analysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Open Bite Activator with Skeletal Anchorage-Supported Vertical ElasticsDevice
Also called Functional Appliance, Vertical Elastics, Mini-Implants
A custom-made acrylic open bite activator was fabricated for each participant, with the bite registered 3-4 mm above freeway space. Miniscrews were placed between the lateral and canine teeth in both jaws. Vertical elastics (150g force) were applied bilaterally between miniscrews and the appliance. The intervention aimed to reduce vertical growth in posterior regions and stimulate anterior dentoalveolar development while improving masseter muscle morphology.
| Study group | Role | What they receive |
|---|---|---|
| Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics | Experimental | Patients were treated using a custom-made open bite activator combined with vertical elastics supported by anterior miniscrews placed between lateral and canine teeth in both jaws. The elastics applied 150g of force bilaterally and were worn for 20-22 hours per day over a 12-month period. The goal was to manage vertical skeletal development and evaluate changes in masseter muscle morphology via ultrasound and sonoelastography. Receives: Device: Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in masseter muscle thickness measured by ultrasonography
Masseter muscle thickness (in millimeters) will be measured at rest and during maximal clenching using ultrasonography at three time points: baseline (T0), 6 months (T1), and 12 months (T2).
Measured: Baseline, 6 months, and 12 months
Secondary outcomes (1)
Change in masseter muscle stiffness assessed by sonoelastography
The ratio of stiff (red) areas to total cross-sectional area of the masseter muscle will be evaluated using shear wave sonoelastography at T0, T1, and T2.
Measured: Baseline, 6 months, and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2025
- Study start15 Jan 2024
- Primary completion15 Jan 2025
- Study completion15 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hyperdivergent Facial PatternStudies of the same condition, open and under way.
- 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
- Not applicable
- Intervention model
- Single group
- Model description
- Participants received treatment with an open bite activator combined with vertical elastics supported by anterior skeletal anchorage in a single group.
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Murat Kaan Erdem
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Murat Kaan Erdem, Ankara University
- Investigators
- Murat K Erdem, PhD, DDS, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06949527
- Sponsor's protocol ID
- ANK-DHF-OBM-2025
- Other IDs
- 36290600/78
- Acronym
- OB-MUSCLE
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 29 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: De-identified individual participant data (IPD) may be shared upon reasonable request. No personal or identifiable information will be included in the shared data.
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasonographic and Sonoelastographic Evaluation of the Effects of Open Bite Activator and Anterior Skeletal Anchorage-Supported Vertical Elastics on the Masseter Muscle in Skeletal Open Bite Cases
- ClinicalTrials.gov ID
- NCT06949527
- Acronym / sponsor ID
- OB-MUSCLE / ANK-DHF-OBM-2025
- Conditions
- Hyperdivergent Facial Pattern, Skeletal Open Bite, Hyperdivergent Growth Pattern, Anterior Open Bite
- Keywords
- Open Bite Treatment, Masseter Muscle, Ultrasound Imaging, Sonoelastography, Skeletal Anchorage, Vertical Elastics, Functional Orthodontic Appliance, Cephalometric Analysis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Murat Kaan ErdemUniversity, hospital or other
- Study start
- 15 Jan 2024 (actual)
- Primary completion
- 15 Jan 2025 (actual)
- Study completion
- 15 Jan 2025 (actual)
- First posted
- 29 Apr 2025 (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 clinical trial aims to evaluate the effects of a combined treatment involving an open bite activator and anterior skeletal anchorage-supported vertical elastics on the masseter muscle in children with skeletal open bite. A total of 24 growing individuals with increased vertical skeletal pattern were treated with a functional appliance and intermaxillary vertical elastics supported by miniscrews placed in the anterior region. Ultrasonographic and sonoelastographic assessments were performed at baseline, 6 months, and 12 months to measure changes in masseter muscle thickness and stiffness. Cephalometric radiographs were also used to evaluate dentofacial structural changes. This study aims to provide insight into the soft tissue changes associated with functional orthopedic treatment in hyperdivergent patients.
Detailed description
This prospective clinical study investigates the dentofacial and muscular effects of a combined orthopedic treatment method in patients with skeletal open bite. The intervention includes the use of an open bite activator appliance along with anterior skeletal anchorage-supported vertical elastics. The study was conducted at Ankara University Faculty of Dentistry, Orthodontics Department, and received ethical approval (Approval No: 36290600/78).
A total of 24 growing individuals (14 females, 10 males) with increased vertical facial pattern (GoGn/SN ≥ 36°) were treated over a 12-month period. Patients received custom-made open bite activators designed to eliminate occlusal contact in the anterior region and redirect functional forces posteriorly. Miniscrews were placed between the lateral and canine teeth in both the maxilla and mandible, and vertical elastics were applied between these skeletal anchorage points with a force of 150 grams on each side, worn for 20-22 hours daily.
Masseter muscle changes were assessed using ultrasonography and sonoelastography at three time points: baseline (T0), interim (6 months, T1), and end of treatment (12 months, T2). Muscle thickness and stiffness (elasticity) were measured bilaterally during rest and maximal clenching. Cephalometric radiographs were obtained at T0 and T2 to evaluate skeletal and dentoalveolar changes, including SNA, SNB, ANB angles, overbite, U1-PP, L1-MP, and other relevant vertical and angular measurements.
Statistical analysis revealed significant increases in masseter muscle thickness during the treatment period, especially between T0 and T1. Stiffness values peaked at T1 and slightly decreased at T2, but remained higher than baseline. Cephalometric findings showed improvements in overbite and reductions in vertical growth tendencies, including significant changes in GoGn/SN and PP-MP angles.
This study demonstrates that combined functional appliance and skeletal anchorage-based vertical control therapy can positively influence muscle structure and dentofacial morphology in hyperdivergent skeletal open bite cases. Ultrasonography and sonoelastography proved to be reliable, non-invasive methods for assessing soft tissue changes in orthodontic treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Participants received treatment with an open bite activator combined with vertical elastics supported by anterior skeletal anchorage in a single group.
| Arm | Type | Receives |
|---|---|---|
| Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics | Experimental | Device: Open Bite Activator with Skeletal Anchorage-Supported Vertical ElasticsPatients were treated using a custom-made open bite activator combined with vertical elastics supported by anterior miniscrews placed between lateral and canine teeth in both jaws. The elastics applied 150g of force bilaterally and were worn for 20-22 hours per day over a 12-month period. The goal was to manage vertical skeletal development and evaluate changes in masseter muscle morphology via ultrasound and sonoelastography. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- GoGn/SN angle ≥ 36°
- Decreased overbite (dental open bite)
- In active growth phase (confirmed by hand-wrist radiograph)
- Good oral hygiene
- No prior orthodontic or orthognathic treatment
Key exclusion criteria (4 listed)
- Presence of systemic disease or craniofacial deformity
- Poor oral hygiene
- Non-compliance with appliance wear
- Previous use of skeletal anchorage devices
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 |
|---|---|---|
| Open Bite Activator with Skeletal Anchorage-Supported Vertical ElasticsAlso: Functional Appliance, Vertical Elastics, Mini-ImplantsA custom-made acrylic open bite activator was fabricated for each participant, with the bite registered 3-4 mm above freeway space. Miniscrews were placed between the lateral and canine teeth in both jaws. Vertical elastics (150g force) were applied bilaterally between miniscrews and the appliance. The intervention aimed to reduce vertical growth in posterior regions and stimulate anterior dentoalveolar development while improving masseter muscle morphology. | Device | Functional Appliance with Skeletal Anchorage-Supported Vertical Elastics |
Primary outcome
Change in masseter muscle thickness measured by ultrasonography
Time frame: Baseline, 6 months, and 12 months
Masseter muscle thickness (in millimeters) will be measured at rest and during maximal clenching using ultrasonography at three time points: baseline (T0), 6 months (T1), and 12 months (T2).
1 secondary outcome
Change in masseter muscle stiffness assessed by sonoelastography
Time frame: Baseline, 6 months, and 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 29 Apr 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD) may be shared upon reasonable request. No personal or identifiable information will be included in the shared data.
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.
Murat K Erdem, PhD, DDS principal investigator
Ankara University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics in people with Hyperdivergent Facial Pattern and Skeletal Open Bite, run by Murat Kaan Erdem 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 29 Apr 2025. 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 masseter muscle thickness measured by ultrasonography (time frame: Baseline, 6 months, and 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 29 Apr 2025.