Treatment Outcome of Clear Aligner and Traditional Fixed Appliances in Four Premolar Extraction Cases

NCT07236775 | Completed DMC

• 1 other identifier: UDDS-Ortho-6-2025
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with severe crowding requiring the extraction of four premolars will be enrolled in this study. The degree of apical root resorption associated with using the clear aligner technique compared with vestibular fixed appliances in the treatment of severe crowding malocclusion cases requiring the extraction of first premolars will be evaluated using cone beam computed tomography (CBCT) volumes. There are two groups: First group (Experimental): the patients in this group will be treated using clear aligners. Second group (Control): the patients in this group will be treated using fixed appliances.

Conditions

Malocclusion, Class I/II; Crowding, Tooth

Outcome Measures

Primary Outcomes (1)

• Change in root length

  The maximum linear lengths between the root apex and incisal edges (for the anterior teeth) or the cusp tips (for the posterior teeth) will be measured on the cone-beam computed tomography (CBCT) images. Differences between the measurements of each tooth before and after treatment provided the amount of apical root resorption in mm. The variable will be measured for each tooth (from the central incisors to the first molars) and on both jaws.

  First assessment: one day before the commencement of treatment (i.e., initiating orthodontic tooth movement). Second assessment: one day following the end of treatment (which is expected to occur within 12 to 18 months).

Study Arms (2)

Clear Aligners

EXPERIMENTAL

Patients in this group will be treated using clear aligners.

Device: Clear Aligners

Fixed appliances

ACTIVE COMPARATOR

Patients in this group will be treated using ordinary fixed appliances.

Device: Traditional fixed appliances

Interventions

Clear Aligners DEVICE

In-house 3D-fabricated clear aligners will be used.

Clear Aligners

Traditional fixed appliances DEVICE

The ordinary metallic braces will be used in a conventional manner.

Fixed appliances

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Adult patients aged 18-25 years.
• Class I malocclusion with severe dental crowding.
• Tooth size-arch discrepancy more than 6 mm.
• No congenitally missing or extracted teeth (except for the wisdom teeth).
• No history of previous trauma to the maxillofacial region or surgical interventions.

You may not qualify if:

• Previous orthodontic treatment.
• Presence of previously occurred ARR.
• Patients with psychological abnormalities or systemic diseases.
• Patients with known allergies to latex or plastic materials.

Sponsors & Collaborators

• Damascus University: lead

Study Sites (1)

Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, Syria

Location

Related Publications (4)

• Jaber ST, Hajeer MY, Burhan AS, Alam MK, Al-Ibrahim HM. Treatment effectiveness of young adults using clear aligners versus buccal fixed appliances in class I malocclusion with first premolar extraction using the ABO-Objective Grading System: A randomized controlled clinical trial. Int Orthod. 2023 Dec;21(4):100817. doi: 10.1016/j.ortho.2023.100817. Epub 2023 Oct 12.

  PMID: 37837842 BACKGROUND

• Jaber ST, Hajeer MY, Sultan K. Treatment Effectiveness of Clear Aligners in Correcting Complicated and Severe Malocclusion Cases Compared to Fixed Orthodontic Appliances: A Systematic Review. Cureus. 2023 Apr 29;15(4):e38311. doi: 10.7759/cureus.38311. eCollection 2023 Apr.

  PMID: 37128600 BACKGROUND

• Jaber ST, Hajeer MY, Burhan AS. The Effectiveness of In-house Clear Aligners and Traditional Fixed Appliances in Achieving Good Occlusion in Complex Orthodontic Cases: A Randomized Control Clinical Trial. Cureus. 2022 Oct 10;14(10):e30147. doi: 10.7759/cureus.30147. eCollection 2022 Oct.

  PMID: 36246088 BACKGROUND

• Jaber ST, Hajeer MY, Burhan AS, Latifeh Y. The Effect of Treatment With Clear Aligners Versus Fixed Appliances on Oral Health-Related Quality of Life in Patients With Severe Crowding: A One-Year Follow-Up Randomized Controlled Clinical Trial. Cureus. 2022 May 30;14(5):e25472. doi: 10.7759/cureus.25472. eCollection 2022 May.

  PMID: 35663697 BACKGROUND

MeSH Terms

Conditions

Malocclusion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases

Study Officials

• Mohammad Younis Hajeer

  Faculty of Dentistry, University of Damascus

  STUDY DIRECTOR

• Samer T. Jaber

  Faculty of Dentistry, University of Damascus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 14, 2025
• First Posted: November 19, 2025
• Study Start: November 10, 2019
• Primary Completion: February 15, 2021
• Study Completion: February 23, 2022
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

SY (1)