An interventional study of Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics in Skeletal Open Bite, Vertical Maxillary Excess and Hyperdivergent Growth Pattern, sponsored by Ankara University. Completed at 1 site in Turkey. Open to participants aged 12 Years to 14 Years. Per ClinicalTrials.gov, last updated 2025-04-20.
Sponsored by Ankara University · Not applicable, Interventional, and Treatment
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 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.
34 studies on the registry are indexed under Open Bite; 8 are open to participants now.
This study's enrollment of 24 is below the median of 30 across 28 interventional studies indexed under Open Bite.
Browse Open Bite studies →Ankara University is the lead sponsor of 320 studies on the registry; 64 are open to participants now.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: Open Bite Activator with Skeletal Anchorage-Supported Vertical Elastics
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.
Also known as: Functional Appliance with Mini-screw-Supported Elastics, Anterior Skeletal Anchorage
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).
Time frame: Baseline to 12 months post-treatment
Plan to share: 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.
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This study is completed, as verified in Apr 2025. You cannot join it, but the record below documents what was studied.
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