Skeletal Open BiteSOBTNCT06936371
Treatment of Skeletal Open Bite With Open Bite Activator and Skeletal Anchorage-Supported Vertical Elastics
A study testing Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics in people with Skeletal Open Bite and Vertical Maxillary Excess, run by Ankara University at 1 site in Turkey (Türkiye).
Trial summary
This study evaluated a new treatment approach for skeletal open bite in growing individuals using an open bite activator combined with anterior skeletal anchorage-supported vertical elastics. An open bite is a condition where the front teeth don't touch when the back teeth are closed together, creating a gap. Read more about this study
- Who is it for?
- Ages 12 to 14 years
- Conditions the study is for
- Skeletal Open Bite, Vertical Maxillary Excess, 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
- 1 Mar 2024to 1 Mar 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
- Growing individuals aged 12-14 years
- Diagnosis of skeletal open bite with GoGn/SN angle ≥36°
- Dentally reduced or negative overbite
- Ongoing growth and development (confirmed with hand-wrist radiographs)
- Good oral hygiene
- No prior orthodontic treatment or orthognathic surgery
- No systemic disease or craniofacial deformity
- Informed consent obtained from participant and parent/guardian
Who cannot join
- Presence of any craniofacial anomaly or systemic condition affecting craniofacial growth
- History of prior orthodontic treatment or jaw surgery
- Poor oral hygiene
- Non-compliance with appliance wear protocol
- Outside the age range of 12-14 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effects of Open Bite Activator and Anterior Skeletal Anchorage-Supported Vertical Elastics on Dentofacial Structures in Skeletal Open Bite Cases
This study evaluated a new treatment approach for skeletal open bite in growing individuals using an open bite activator combined with anterior skeletal anchorage-supported vertical elastics. An open bite is a condition where the front teeth don't touch when the back teeth are closed together, creating a gap. Traditional treatments often use extraoral appliances (devices worn outside the mouth), which can be uncomfortable and aesthetically unappealing, leading to poor patient compliance.
We included 24 growing patients (14 females, 10 males) aged 12-14 years with skeletal open bite. All participants received an open bite activator (a removable functional appliance) and mini-screws placed between the upper and lower lateral and canine teeth. Vertical elastics were connected between these mini-screws, applying 150g of force for 20-22 hours daily over 12 months.
Read more
Lateral cephalometric radiographs (specialized X-rays) were taken before treatment and after 12 months to evaluate changes in facial bone structure and tooth positions. Our results showed successful correction of open bite with an average increase in overbite of 3.35mm. We observed favorable skeletal changes including clockwise rotation of the maxilla (upper jaw), counterclockwise rotation of the mandible (lower jaw), and decreased vertical facial dimensions.
This treatment approach offers a viable alternative to conventional methods that rely on extraoral appliances, potentially improving patient comfort and compliance. The protocol successfully addresses both skeletal and dental components of open bite malocclusion in growing patients.
Read the detailed description
Detailed Description This prospective interventional study aimed to develop and evaluate a novel treatment protocol for skeletal open bite that eliminates the need for extraoral appliances while achieving comparable therapeutic outcomes. Skeletal open bite represents a challenging orthodontic condition characterized by increased vertical facial dimensions, divergent skeletal planes, and negative overbite.
Our treatment protocol combined two therapeutic approaches: (1) a modified open bite activator constructed with 3-4mm addition to the freeway space and relief in the anterior region, and (2) skeletal anchorage using mini-screws placed in the anterior region between lateral and canine teeth in both arches, connected by vertical intermaxillary elastics.
The open bite activator component functioned through multiple mechanisms: acting as a posterior bite block to inhibit posterior dentoalveolar eruption, serving as a tongue barrier to prevent tongue thrust between anterior teeth, and directing masticatory forces to the posterior segments. The anterior relief in the appliance allowed for uninhibited eruption of incisors. The vertical elastics between mini-screws provided controlled force (150g) to facilitate favorable rotational movements of the maxilla and mandible.
Cephalometric analyses included comprehensive skeletal angular measurements (SNA, SNB, ANB, Y Axis, SN/PP, GoGn/SN, PP/MP, gonial angle), skeletal linear measurements (N-Me, ANS-Me, Co-Go, S-Go), skeletal proportional measurements (Jarabak ratio), dentoalveolar angular measurements (U1-PP, interincisal angle, IMPA), and dentoalveolar linear measurements (overjet, overbite, U1-PP, U6-PP, L1-MP, L6-MP).
This treatment protocol demonstrates the potential to achieve effects similar to traditional approaches using posterior high-pull headgear and vertical chin cup, without compromising treatment outcomes. The significance of this approach lies in its ability to address a primary challenge in orthodontic treatment of growing patients with skeletal open bite: patient compliance and comfort, which often determines treatment success.
- Conditions
- Skeletal Open Bite, Vertical Maxillary Excess, Hyperdivergent Growth Pattern, Long Face Syndrome
- Being tested
- Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
- Keywords
- Open Bite Activator, Skeletal Anchorage, Mini-screws, Vertical Elastics, Orthodontic Treatment, Anterior Open Bite, Bite Correction, Dentofacial Effects, Cephalometric Analysis, Growing Patients, Non-extraction Treatment, Functional Appliance, Vertical Dimension Control
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 with Mini-screw-Supported Elastics, Anterior Skeletal Anchorage
Participants received a removable open bite activator constructed with the mandible opened beyond the freeway space and combined with vertical intermaxillary elastics applying 150g of force, supported by mini-screws placed between the lateral and canine teeth in both the maxilla and mandible. The appliance was worn 20-22 hours daily for 12 months. This approach aimed to treat skeletal open bite without using extraoral appliances by promoting anterior mandibular rotation and inhibiting posterior vertical dentoalveolar development.
| Study group | Role | What they receive |
|---|---|---|
| Functional Appliance and Skeletal Anchorage Group | Experimental | This arm includes growing individuals with skeletal open bite treated using a combination of an open bite activator (functional appliance) and vertical intermaxillary elastics supported by anterior skeletal anchorage (mini-screws placed between lateral and canine teeth in both jaws). The appliance was worn full-time for 12 months. Cephalometric changes were evaluated before and after treatment to assess skeletal and dentoalveolar effects without the use of extraoral appliances. 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 GoGn/SN Angle (Mandibular Plane Angle) from Baseline to 12 Months
This outcome assesses the change in the mandibular plane angle (GoGn/SN) using lateral cephalometric radiographs taken at the beginning of treatment (T0) and after 12 months of therapy (T1). A decrease in the GoGn/SN angle indicates counterclockwise rotation of the mandible, which is a favorable skeletal change in the treatment of skeletal open bite. Measurements were performed using standardized digital cephalometric analysis software (Dolphin Imaging 11.95).
Measured: Baseline to 12 months post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2025
- Study start1 Mar 2024
- Primary completion1 Mar 2025
- Study completion1 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skeletal Open BiteStudies of the same condition, open and under way.
- More trials run by Ankara 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
- Not applicable
- Intervention model
- Single group
- Model description
- This prospective interventional study employed a single-group design where all participants received the same treatment protocol: open bite activator combined with skeletal anchorage-supported vertical elastics. Participants were evaluated at baseline (T0) and after 12 months of treatment (T1).
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ankara University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Murat Kaan Erdem, Ankara University
- Investigators
- Elif Değirmenci, DDS, PhD, Principal investigator, Ankara University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06936371
- Sponsor's protocol ID
- AUFDT-ORT-2021-22
- Other IDs
- 36290600/22
- Acronym
- SOBT
- Status last verified
- Apr 2025
- First submitted
- 13 Apr 2025
- Last updated
- 20 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), including cephalometric measurements, will be made available upon reasonable request to qualified researchers following publication. Requests should be directed to the corresponding author and will require a data use agreement.
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effects of Open Bite Activator and Anterior Skeletal Anchorage-Supported Vertical Elastics on Dentofacial Structures in Skeletal Open Bite Cases
- ClinicalTrials.gov ID
- NCT06936371
- Acronym / sponsor ID
- SOBT / AUFDT-ORT-2021-22
- Conditions
- Skeletal Open Bite, Vertical Maxillary Excess, Hyperdivergent Growth Pattern, Long Face Syndrome
- Keywords
- Open Bite Activator, Skeletal Anchorage, Mini-screws, Vertical Elastics, Orthodontic Treatment, Anterior Open Bite, Bite Correction, Dentofacial Effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Ankara UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Mar 2025 (actual)
- Study completion
- 1 Mar 2025 (actual)
- First posted
- 20 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 study evaluated a new treatment approach for skeletal open bite in growing individuals using an open bite activator combined with anterior skeletal anchorage-supported vertical elastics. An open bite is a condition where the front teeth don't touch when the back teeth are closed together, creating a gap. Traditional treatments often use extraoral appliances (devices worn outside the mouth), which can be uncomfortable and aesthetically unappealing, leading to poor patient compliance.
We included 24 growing patients (14 females, 10 males) aged 12-14 years with skeletal open bite. All participants received an open bite activator (a removable functional appliance) and mini-screws placed between the upper and lower lateral and canine teeth. Vertical elastics were connected between these mini-screws, applying 150g of force for 20-22 hours daily over 12 months.
Lateral cephalometric radiographs (specialized X-rays) were taken before treatment and after 12 months to evaluate changes in facial bone structure and tooth positions. Our results showed successful correction of open bite with an average increase in overbite of 3.35mm. We observed favorable skeletal changes including clockwise rotation of the maxilla (upper jaw), counterclockwise rotation of the mandible (lower jaw), and decreased vertical facial dimensions.
This treatment approach offers a viable alternative to conventional methods that rely on extraoral appliances, potentially improving patient comfort and compliance. The protocol successfully addresses both skeletal and dental components of open bite malocclusion in growing patients.
Detailed description
Detailed Description This prospective interventional study aimed to develop and evaluate a novel treatment protocol for skeletal open bite that eliminates the need for extraoral appliances while achieving comparable therapeutic outcomes. Skeletal open bite represents a challenging orthodontic condition characterized by increased vertical facial dimensions, divergent skeletal planes, and negative overbite.
Our treatment protocol combined two therapeutic approaches: (1) a modified open bite activator constructed with 3-4mm addition to the freeway space and relief in the anterior region, and (2) skeletal anchorage using mini-screws placed in the anterior region between lateral and canine teeth in both arches, connected by vertical intermaxillary elastics.
The open bite activator component functioned through multiple mechanisms: acting as a posterior bite block to inhibit posterior dentoalveolar eruption, serving as a tongue barrier to prevent tongue thrust between anterior teeth, and directing masticatory forces to the posterior segments. The anterior relief in the appliance allowed for uninhibited eruption of incisors. The vertical elastics between mini-screws provided controlled force (150g) to facilitate favorable rotational movements of the maxilla and mandible.
Cephalometric analyses included comprehensive skeletal angular measurements (SNA, SNB, ANB, Y Axis, SN/PP, GoGn/SN, PP/MP, gonial angle), skeletal linear measurements (N-Me, ANS-Me, Co-Go, S-Go), skeletal proportional measurements (Jarabak ratio), dentoalveolar angular measurements (U1-PP, interincisal angle, IMPA), and dentoalveolar linear measurements (overjet, overbite, U1-PP, U6-PP, L1-MP, L6-MP).
This treatment protocol demonstrates the potential to achieve effects similar to traditional approaches using posterior high-pull headgear and vertical chin cup, without compromising treatment outcomes. The significance of this approach lies in its ability to address a primary challenge in orthodontic treatment of growing patients with skeletal open bite: patient compliance and comfort, which often determines treatment success.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This prospective interventional study employed a single-group design where all participants received the same treatment protocol: open bite activator combined with skeletal anchorage-supported vertical elastics. Participants were evaluated at baseline (T0) and after 12 months of treatment (T1).
| Arm | Type | Receives |
|---|---|---|
| Functional Appliance and Skeletal Anchorage Group | Experimental | Device: Open Bite Activator with Skeletal Anchorage-Supported Vertical ElasticsThis arm includes growing individuals with skeletal open bite treated using a combination of an open bite activator (functional appliance) and vertical intermaxillary elastics supported by anterior skeletal anchorage (mini-screws placed between lateral and canine teeth in both jaws). The appliance was worn full-time for 12 months. Cephalometric changes were evaluated before and after treatment to assess skeletal and dentoalveolar effects without the use of extraoral appliances. |
Who may qualify
- Ages
- 12 to 14 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (8 listed)
- Growing individuals aged 12-14 years
- Diagnosis of skeletal open bite with GoGn/SN angle ≥36°
- Dentally reduced or negative overbite
- Ongoing growth and development (confirmed with hand-wrist radiographs)
- Good oral hygiene
Key exclusion criteria (5 listed)
- Presence of any craniofacial anomaly or systemic condition affecting craniofacial growth
- History of prior orthodontic treatment or jaw surgery
- Poor oral hygiene
- Non-compliance with appliance wear protocol
- Outside the age range of 12-14 years
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 with Mini-screw-Supported Elastics, Anterior Skeletal AnchorageParticipants received a removable open bite activator constructed with the mandible opened beyond the freeway space and combined with vertical intermaxillary elastics applying 150g of force, supported by mini-screws placed between the lateral and canine teeth in both the maxilla and mandible. The appliance was worn 20-22 hours daily for 12 months. This approach aimed to treat skeletal open bite without using extraoral appliances by promoting anterior mandibular rotation and inhibiting posterior vertical dentoalveolar development. | Device | Functional Appliance and Skeletal Anchorage Group |
Primary outcome
Change in GoGn/SN Angle (Mandibular Plane Angle) from Baseline to 12 Months
Time frame: Baseline to 12 months post-treatment
This outcome assesses the change in the mandibular plane angle (GoGn/SN) using lateral cephalometric radiographs taken at the beginning of treatment (T0) and after 12 months of therapy (T1). A decrease in the GoGn/SN angle indicates counterclockwise rotation of the mandible, which is a favorable skeletal change in the treatment of skeletal open bite. Measurements were performed using standardized digital cephalometric analysis software (Dolphin Imaging 11.95).
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 20 Apr 2025.
- Individual participant dataSharing planned: Undecided. De-identified individual participant data (IPD), including cephalometric measurements, will be made available upon reasonable request to qualified researchers following publication. Requests should be directed to the corresponding author and will require a data use agreement.
Related trials for Skeletal Open Bite
Active, not recruiting
Anterior Open Bite Closure by Clear Aligners Versus Fixed Appliances in Adult Patients With Skeletal Open Bite: A Randomized Clinical Trial.
Skeletal Open Bite, Open Bite
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.
Elif Değirmenci, DDS, PhD 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 Skeletal Open Bite and Vertical Maxillary Excess, run by Ankara 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 8 inclusion and 5 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 20 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 GoGn/SN Angle (Mandibular Plane Angle) from Baseline to 12 Months (time frame: Baseline to 12 months post-treatment). 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 20 Apr 2025.