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

NCT ID: NCT07236775

Last Updated: 2025-11-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-10

Study Completion Date

2022-02-23

Brief Summary

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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.

Detailed Description

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With the increasing number of young adults requesting esthetic orthodontic treatment, clear aligners have continued to gain widespread use, driven by greater consideration of esthetic aspects and oral health-related quality of life compared to traditional fixed orthodontic appliances. Recently, clear aligners have been used in more complex malocclusion cases that require premolar extraction. Teeth root resorption occurs due to physiological or pathological causes that lead to loss of tooth structure. Apical root resorption (ARR) is a common side effect of orthodontic treatment that requires careful investigation of its location and frequency.

Conditions

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Malocclusion, Class I/II Crowding, Tooth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Clear Aligners

Patients in this group will be treated using clear aligners.

Group Type EXPERIMENTAL

Clear Aligners

Intervention Type DEVICE

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

Fixed appliances

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

Group Type ACTIVE_COMPARATOR

Traditional fixed appliances

Intervention Type DEVICE

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

Interventions

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Clear Aligners

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

Intervention Type DEVICE

Traditional fixed appliances

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

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

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Damascus University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mohammad Younis Hajeer

Role: STUDY_DIRECTOR

Faculty of Dentistry, University of Damascus

Samer T. Jaber

Role: PRINCIPAL_INVESTIGATOR

Faculty of Dentistry, University of Damascus

Locations

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Department of Orthodontics, Faculty of Dentistry, University of Damascus

Damascus, , Syria

Site Status

Countries

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Syria

References

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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.

Reference Type BACKGROUND
PMID: 37837842 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 37128600 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 36246088 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 35663697 (View on PubMed)

Other Identifiers

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UDDS-Ortho-6-2025

Identifier Type: -

Identifier Source: org_study_id

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