Health TrialsbyHealthPanel

Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite

ConditionsOpen BiteMalocclusion Class I
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-30
SponsorSana'a University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

Previous orthodontic treatment. Presence of craniofacial anomalies or cleft lip/palate. Active periodontal disease or severe bone loss. History of temporomandibular joint disorders (TMD). Systemic conditions or medications affecting bone metabolism and tooth movement.

Trial design

Design model

Parallel

Treatments tested in this trial

  • In-House Clear Aligners

    Device

    Thermoplastic clear aligners (PETG 0.75-0.8 mm) manufactured in-house for vertical open bite closure, combined with composite attachments and intermaxillary elastics.

  • Fixed Orthodontic Appliances

    Device

    Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.

Treatment groups

46 Participants
are divided into 2 treatment groups
Group A: Clear Aligner GroupExperimental treatment 1 intervention
Group B: Fixed Appliance GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Overbite Change

Changes in anterior vertical overlap measured in millimeters on 3D digital dental models from baseline to the end of active treatment.

Time frame
Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)

Secondary outcomes

1

Cephalometric Skeletal Changes

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
2

Cephalometric Dental Changes

Changes in upper and lower incisor inclinations (U1-SN and L1-MP angles, measured in degrees) evaluated on lateral cephalometric radiographs.

Time frame
Baseline and through study completion, an average of 18 months

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Sana'a University

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: