Malocclusion, Class I/IINCT07236775
Treatment Outcome of Clear Aligner and Traditional Fixed Appliances in Four Premolar Extraction Cases
A study testing Clear Aligners and Traditional fixed appliances in people with Malocclusion, Class I/II and Crowding, Tooth, run by Damascus University at 1 site in Syria.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Malocclusion, Class I/II, Crowding, Tooth
- What is being tested?
- Clear Aligners and Traditional fixed appliances
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteSyria
- Study dates
- 10 Nov 2019to 23 Feb 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- Previous orthodontic treatment.
- Presence of previously occurred ARR.
- Patients with psychological abnormalities or systemic diseases.
- Patients with known allergies to latex or plastic materials.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus
About this study
Official title: 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
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.
Read the 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.
- Conditions
- Malocclusion, Class I/II, Crowding, Tooth
- Being tested
- Clear Aligners, Traditional fixed appliances
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clear AlignersDevice
In-house 3D-fabricated clear aligners will be used.
Traditional fixed appliancesDevice
The ordinary metallic braces will be used in a conventional manner.
| Study group | Role | What they receive |
|---|---|---|
| Clear Aligners | Experimental | Patients in this group will be treated using clear aligners. Receives: Device: Clear Aligners |
| Fixed appliances | Active comparator | Patients in this group will be treated using ordinary fixed appliances. Receives: Device: Traditional fixed appliances |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2025
- Study start10 Nov 2019
- Primary completion15 Feb 2021
- Study completion23 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Malocclusion, Class I/IIStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Younis Hajeer, Study director, Faculty of Dentistry, University of DamascusSamer T. Jaber, Principal investigator, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07236775
- Sponsor's protocol ID
- UDDS-Ortho-6-2025
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 37837842Jaber 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.
PubMed 37128600Jaber 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.
PubMed 36246088Jaber 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.
PubMed 35663697
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07236775
- Acronym / sponsor ID
- UDDS-Ortho-6-2025
- Conditions
- Malocclusion, Class I/II, Crowding, Tooth
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 10 Nov 2019 (actual)
- Primary completion
- 15 Feb 2021 (actual)
- Study completion
- 23 Feb 2022 (actual)
- First posted
- 19 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Clear Aligners | Experimental | Device: Clear AlignersPatients in this group will be treated using clear aligners. |
| Fixed appliances | Active comparator | Device: Traditional fixed appliancesPatients in this group will be treated using ordinary fixed appliances. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (4 listed)
- Previous orthodontic treatment.
- Presence of previously occurred ARR.
- Patients with psychological abnormalities or systemic diseases.
- Patients with known allergies to latex or plastic materials.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clear AlignersIn-house 3D-fabricated clear aligners will be used. | Device | Clear Aligners |
| Traditional fixed appliancesThe ordinary metallic braces will be used in a conventional manner. | Device | Fixed appliances |
Primary outcome
Change in root length
Time frame: 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).
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Background: PubMed 37837842Jaber 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.
- Background: PubMed 37128600Jaber 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.
- Background: PubMed 36246088Jaber 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.
- Background: PubMed 35663697Jaber 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mohammad Younis Hajeer study director
Faculty of Dentistry, University of Damascus
Samer T. Jaber principal investigator
Faculty of Dentistry, University of Damascus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clear Aligners and Traditional fixed appliances in people with Malocclusion, Class I/II and Crowding, Tooth, run by Damascus University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in root length (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07236775, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Nov 2025.