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

NCT07778108 | Not Yet Recruiting

• 1 other identifier: SU-FD-ORTHO-2026-01
• Study Type: interventional
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Open Bite; Malocclusion Class I

Keywords

Anterior Open Bite; Clear Aligners; Fixed Orthodontic Appliances; Randomized Controlled Clinical Trial; Orthodontic Stability

Outcome Measures

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.

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

Secondary Outcomes (2)

• 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

Study Arms (2)

Clear Aligner Group

EXPERIMENTAL

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.

Device: In-House Clear Aligners

Fixed Appliance Group

ACTIVE COMPARATOR

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.

Device: Fixed Orthodontic Appliances

Interventions

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.

Also known as: PETG Aligners

Clear Aligner Group

Fixed Orthodontic Appliances DEVICE

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

Fixed Appliance Group

Eligibility Criteria

• Age: 18 Years - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sana'a University: lead

MeSH Terms

Conditions

Open Bite

Interventions

Orthodontic Appliances, Fixed

Condition Hierarchy (Ancestors)

Malocclusion; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Orthodontic Appliances; Orthodontics; Dentistry

Study Officials

• Ghamdan Al-Harazi, PhD

  Sana'a University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Othman Ahmed Othman Ali, BDS, MSc

CONTACT

00967738718234; othman.othman@su.edu.ye

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Researcher

Study Record Dates

• First Submitted: August 17, 2026
• First Posted: August 21, 2026
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): July 1, 2029
• Last Updated: August 21, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share