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

Evaluation of the Apical Root Resorption in Young Adults Caused by Orthodontic Treatment of Class I Severe Crowding Cases Using Clear Aligners Versus Traditional Fixed Appliances: A Randomized Controlled Clinical Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07236775
Enrollment
40
Registered
2025-11-19
Start date
2019-11-10
Completion date
2022-02-23
Last updated
2025-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Malocclusion, Class I/II, Crowding, Tooth

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.

Detailed description

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.

Interventions

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

DEVICETraditional fixed appliances

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

Sponsors

Damascus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 25 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Change in root lengthFirst 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).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.

Countries

Syria

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026