Clinical Comparison of Clear Aligners and Fixed Appliances in Dental Anterior Open Bite
Clinical Comparison of Clear Aligners and Fixed Orthodontic Appliances in the Treatment of Dental Anterior Open Bite in Adults: A Randomized Controlled Clinical 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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Othman Ahmed Othman Ali, BDS, MSc
- Phone Number: 00967738718234
- Email: othman.othman@su.edu.ye
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
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.
-
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Clear Aligner Group
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.
|
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:
|
|
Active Comparator: Fixed Appliance Group
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.
|
Conventional 0.022-inch MBT prescription fixed brackets utilizing two-segment arch mechanics and intermaxillary vertical elastics.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overbite Change
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.
|
Baseline (T0) and completion of active treatment (T1, approximately 12-18 months)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cephalometric Skeletal Changes
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.
|
Baseline and through study completion, an average of 18 months
|
|
Cephalometric Dental Changes
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.
|
Baseline and through study completion, an average of 18 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Ghamdan Al-Harazi, PhD, Sana'a University
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- SU-FD-ORTHO-2026-01
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.