In-House Clear Aligners
DeviceThermoplastic clear aligners (PETG 0.75-0.8 mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.
Other names: PETG Aligners
NCT Number: NCT07778108
Dental anterior open bite is a challenging orthodontic condition with a high risk of relapse in adults. This randomized controlled clinical trial aims to compare the effectiveness and post-treatment stability of in-house clear aligners versus fixed orthodontic appliances in treating adult patients aged 18-30 years with dental anterior open bite (0 to -4 mm).
A total of 46 eligible participants will be randomly allocated into two equal groups (23 treated with clear aligners and 23 with fixed appliances). Treatment outcomes, vertical dentoalveolar changes, and skeletal changes will be evaluated using digital intraoral scans, virtual model superimposition, and lateral cephalometric analysis. Following active treatment, an 8-month retention phase (bonded lingual retainer combined with a vacuum-formed retainer) and an 8-month post-retention follow-up phase will be implemented to comprehensively evaluate treatment stability and relapse tendency over a total observation period of 16 months.
Trial opening soon.
Get Notified18 year–30 year
All sexes
Interventional
Not applicable
Anterior open bite (AOB) in adults presents significant treatment challenges due to the absence of remaining growth and a high relapse tendency. While fixed orthodontic appliances remain the standard approach for vertical control, clear aligner therapy has gained popularity despite limited randomized controlled evidence regarding its long-term predictability and stability.
This study is designed as a single-center, parallel-group, randomized controlled clinical trial conducted at the Faculty of Dentistry, Sana'a University. Enrolled participants meet strict inclusion criteria: adult age (18-30 years), dental anterior open bite (0 to -4 mm), Class I malocclusion with normal molar relationships, non-extraction treatment requirements (crowding/spacing \\le 4\\text{ mm}), and good oral hygiene.
Participants in the Clear Aligner group receive fully digital in-house aligners fabricated using Zahndent intraoral scans, 3D Maestro setup software, Elegoo Saturn 4 Ultra 16K printing, and PETG thermoforming sheets (0.75-0.8 mm). Aligner mechanics include optimized attachments and medium power intermaxillary elastics (3-4.5 oz) worn 20-22 hours per day. Participants in the Fixed Appliance group are treated using 0.022-inch MBT prescription brackets with a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and vertical elastics.
Primary and secondary outcomes-including overbite increase, cephalometric vertical changes, treatment efficiency, patient compliance, and satisfaction-will be recorded at baseline, post-treatment, after 8 months of retention, and after 8 months of post-retention follow-up.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Adult patients aged 18 to 30 years with fully erupted permanent dentition. Anterior open bite equal to or greater than 2 mm. Angle Class I malocclusion. Good oral hygiene and healthy periodontal status.
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Exclusion criteria
Thermoplastic clear aligners (PETG 0.75-0.8 mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.
Other names: PETG Aligners
Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.
Time frame: Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.
Time frame: Baseline and through study completion, an average of 18 months
Changes in vertical and sagittal skeletal relationships (SN-GoGn angle, measured in degrees) evaluated on lateral cephalometric radiographs.
Time frame: Baseline and through study completion, an average of 18 months
Changes in upper and lower incisor inclinations (U1-SN and L1-MP angles, measured in degrees) evaluated on lateral cephalometric radiographs.
Contact information is provided by the study sponsor or research team.
Sana'a University
Other
Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical Trial
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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