NCT07778108|Not Yet Recruiting
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Sponsor study identifier
interventional
46
0 countries
N/A
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 17, 2026
Actual (reported)August 21, 2026
Actual (reported)November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
March 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Overbite Change
Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.
Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
Cephalometric Skeletal Changes
Baseline and through study completion, an average of 18 months
Cephalometric Dental Changes
Baseline and through study completion, an average of 18 months
Participants receive in-house manufactured PETG clear aligners (0.75-0.8 mm) designed with 3D Maestro setup software and printed using Elegoo Saturn 4 Ultra 16K. Aligners are changed every 10-14 days, combined with optimized composite attachments and medium power intermaxillary vertical elastics (3-4.5 oz) worn 20-22 hours daily.
Participants receive conventional fixed orthodontic appliances with 0.022-inch MBT prescription brackets. Treatment utilizes a two-segment arch mechanics approach (canine-to-canine anterior segment and premolar/molar posterior segment) combined with progressive wire sequencing and intermaxillary vertical elastics.
Thermoplastic clear aligners (PETG 0.75-0.8 mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.
Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.
Ghamdan Al-Harazi, PhD
Sana'a University
First Submitted
August 17, 2026
First Posted
August 21, 2026
Study Start
November 2026
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Primary Completion
March 2028
Early Treatment of Skeletal Anterior Open Bite by Two Appliances
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 21, 2026
Record last verified: 2026-08
Individual participant data will not be shared to protect participant privacy and confidentiality.
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Source: ClinicalTrials.gov.
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