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

NCT07778108 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 46

Last updated 2026-08-21

No results posted yet for this study

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

Interventions

DEVICE

In-House Clear Aligners

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

DEVICE

Fixed Orthodontic Appliances

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

Sponsors & Collaborators

  • Sana'a University

    lead OTHER

Principal Investigators

  • Ghamdan Al-Harazi, PhD · Sana'a University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
30 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-11-30
Primary Completion
2028-03-31
Completion
2029-07-31

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07778108 on ClinicalTrials.gov