Effect of Direct Printed Aligners on Root TorqueCBCTNCT07273552
Root Torque Control in Cases Treated With Direct Printed Aligners
A study testing Direct printed aligners in people with Effect of Direct Printed Aligners on Root Torque, run by Suez Canal University at 3 sites in Egypt.
Trial summary
This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Effect of Direct Printed Aligners on Root Torque
- What is being tested?
- Direct printed aligners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 3 sitesEgypt
- Study dates
- 1 Jun 2025to 1 Jul 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18- 45 years old.
- Non- extraction treatment.
- Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
- Normal probing depth.
Who cannot join
- Active periodontal disease.
- Crowding cases.
- Systemic diseases or medications that alter bone metabolism or tooth movement.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt3 sites, 3 recruiting
- Recruiting
Beni-Suef University
Banī Suwayf
Rehab M Khalil, PhD of Orthodontics, 00201005230069, rehababdelrazek@dent.bsu.edu.eg
Rehab M Khalil, PhD of Orthodontics
- Recruiting
British University in Egypt
Cairo
Ahmad Elshennawy, Master of Orthodontics, 00201003615662, elshennawy.ahmad@gmail.com
Ahmad Elshennawy, Master of Orthodontics
- Recruiting
Suez Canal University
Ismailia
Rim M Fathalla, PhD of Orthodontics, 00201222726567, rim_fathalla@dent.suez.edu.eg
Rim M Fathalla, PhD of Orthodontics
About this study
Official title: Efficacy of Root Torque Control in Adult Non-extraction Spacing Cases Treated With Directly 3D Printed Clear Aligners: a Cone Beam Computed Tomography Study
This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption.
Read the detailed description
Participants will be recruited from the Faculty of Dentistry, Beni Suef, Suez Canal, and British Universities. All subjects will be informed of the treatment procedures and will sign a consent form.
the minimum total required sample size (n) was found to be (14) cases. The sample size was calculated using R statistical analysis software version 4.5.0 for Windows[11].
Methodology:
- Cone beam computed tomography scans will be done before treatment (T0).
- Intraoral scanning of the patients will be performed by using an intraoral scanner to obtain pre-treatment digital models of the upper and lower arches. The treatment plan will be set up, and the aligners will be 3D printed.
- The patient will be instructed to immerse the aligners in warm water before inserting them into the mouth to soften them and improve their fit. The patient will be instructed to change the aligners every week.
- At the end of orthodontic treatment (within 9 months - 2 years after the beginning of the treatment), a post-treatment CBCT scan will be obtained (T1)
- The achieved torque movement of the upper and lower incisors will be calculated by evaluated the pre and post CBCT scans taking the difference between T0 and T1.
- The difference between achieved and predicted torque movement (DAPM) will be obtained, and the efficiency will be calculated by dividing the achieved movement / predicted movement X 100 %
- The labial and palatal bone thickness and root length of the upper and lower incisors will be measured at T0 and T1 by using the pre and post cone-beam computed tomography, and the difference will be calculated.
The results will be obtained and statistically analyzed.
- Being tested
- Direct printed aligners
- Keywords
- Direct printed aligners torque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Direct printed alignersOther
After intraoral scanning and CBCT taking, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post-CBCT scan will be taken from each patient.
| Study group | Role | What they receive |
|---|---|---|
| Patients with spacing | Experimental | Patients will receive direct printed aligners to treat the spacing Receives: Other: Direct printed aligners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .
Measured: 9-12 months
Secondary outcomes (2)
Change in the bone thickness (measured in mm) around the upper and lower incisors associated with the achieved root torque.
Measured: 9-12 months
Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.
Measured: 9-12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jun 2025
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Effect of Direct Printed Aligners on Root TorqueStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Suez Canal University
- Sponsor type
- University, hospital or other
- Collaborators
- British University In Egypt, Beni-Suef University
- Responsible party
- Principal investigator, rim fathalla, Suez Canal University
- Investigators
- Rim M Fathalla, PhD of Orthodontics, Principal investigator, Suez Canal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07273552
- Sponsor's protocol ID
- #REC-FDBSU/08052025-01/AR
- Acronym
- CBCT
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Iglesias-Linares A, Sonnenberg B, Solano B, Yanez-Vico RM, Solano E, Lindauer SJ, Flores-Mir C. Orthodontically induced external apical root resorption in patients treated with fixed appliances vs removable aligners. Angle Orthod. 2017 Jan;87(1):3-10. doi: 10.2319/02016-101.1. Epub 2016 Aug 9.
PubMed 27504821Li Y, Deng S, Mei L, Li Z, Zhang X, Yang C, Li Y. Prevalence and severity of apical root resorption during orthodontic treatment with clear aligners and fixed appliances: a cone beam computed tomography study. Prog Orthod. 2020 Jan 6;21(1):1. doi: 10.1186/s40510-019-0301-1.
PubMed 31903505Lacruz RS, de Castro JM, Martinon-Torres M, O'Higgins P, Paine ML, Carbonell E, Arsuaga JL, Bromage TG. Facial morphogenesis of the earliest europeans. PLoS One. 2013 Jun 6;8(6):e65199. doi: 10.1371/journal.pone.0065199. Print 2013.
PubMed 23762314Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.
PubMed 26629473Sfondrini MF, Gandini P, Castroflorio T, Garino F, Mergati L, D'Anca K, Trovati F, Scribante A. Buccolingual Inclination Control of Upper Central Incisors of Aligners: A Comparison with Conventional and Self-Ligating Brackets. Biomed Res Int. 2018 Nov 29;2018:9341821. doi: 10.1155/2018/9341821. eCollection 2018.
PubMed 30627583Tartaglia GM, Mapelli A, Maspero C, Santaniello T, Serafin M, Farronato M, Caprioglio A. Direct 3D Printing of Clear Orthodontic Aligners: Current State and Future Possibilities. Materials (Basel). 2021 Apr 5;14(7):1799. doi: 10.3390/ma14071799.
PubMed 33916462
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Root Torque Control in Adult Non-extraction Spacing Cases Treated With Directly 3D Printed Clear Aligners: a Cone Beam Computed Tomography Study
- ClinicalTrials.gov ID
- NCT07273552
- Acronym / sponsor ID
- CBCT / #REC-FDBSU/08052025-01/AR
- Keywords
- Direct printed aligners torque
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- Suez Canal UniversityUniversity, hospital or other
- Collaborators
- British University In Egypt, Beni-Suef University
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Jul 2026 (estimated)
- First posted
- 9 Dec 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.
This study aims to three-dimensionally evaluate the efficiency of direct 3D printed aligners in achieving the planned root torque by using CBCT and to assess the associated bone thickness changes and root resorption.
Detailed description
Participants will be recruited from the Faculty of Dentistry, Beni Suef, Suez Canal, and British Universities. All subjects will be informed of the treatment procedures and will sign a consent form.
the minimum total required sample size (n) was found to be (14) cases. The sample size was calculated using R statistical analysis software version 4.5.0 for Windows[11].
Methodology:
- Cone beam computed tomography scans will be done before treatment (T0).
- Intraoral scanning of the patients will be performed by using an intraoral scanner to obtain pre-treatment digital models of the upper and lower arches. The treatment plan will be set up, and the aligners will be 3D printed.
- The patient will be instructed to immerse the aligners in warm water before inserting them into the mouth to soften them and improve their fit. The patient will be instructed to change the aligners every week.
- At the end of orthodontic treatment (within 9 months - 2 years after the beginning of the treatment), a post-treatment CBCT scan will be obtained (T1)
- The achieved torque movement of the upper and lower incisors will be calculated by evaluated the pre and post CBCT scans taking the difference between T0 and T1.
- The difference between achieved and predicted torque movement (DAPM) will be obtained, and the efficiency will be calculated by dividing the achieved movement / predicted movement X 100 %
- The labial and palatal bone thickness and root length of the upper and lower incisors will be measured at T0 and T1 by using the pre and post cone-beam computed tomography, and the difference will be calculated.
The results will be obtained and statistically analyzed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with spacing | Experimental | Other: Direct printed alignersPatients will receive direct printed aligners to treat the spacing |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age: 18- 45 years old.
- Non- extraction treatment.
- Angle Class I or Class II dental malocclusion with generalized or localized anterior spacing.
- Normal probing depth.
Key exclusion criteria (3 listed)
- Active periodontal disease.
- Crowding cases.
- Systemic diseases or medications that alter bone metabolism or tooth movement.
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 |
|---|---|---|
| Direct printed alignersAfter intraoral scanning and CBCT taking, patients will receive Direct printed aligners, each set will be changed after 10 days, till the patients finish their treatment, then a post-CBCT scan will be taken from each patient. | Other | Patients with spacing |
Primary outcome
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors .
Time frame: 9-12 months
2 secondary outcomes
Change in the bone thickness (measured in mm) around the upper and lower incisors associated with the achieved root torque.
Time frame: 9-12 months
Assessment of amount of root resorption (measured in mm) of upper and lower incisors associated with root torque.
Time frame: 9-12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publication: PubMed 27504821Iglesias-Linares A, Sonnenberg B, Solano B, Yanez-Vico RM, Solano E, Lindauer SJ, Flores-Mir C. Orthodontically induced external apical root resorption in patients treated with fixed appliances vs removable aligners. Angle Orthod. 2017 Jan;87(1):3-10. doi: 10.2319/02016-101.1. Epub 2016 Aug 9.
- Results publication: PubMed 31903505Li Y, Deng S, Mei L, Li Z, Zhang X, Yang C, Li Y. Prevalence and severity of apical root resorption during orthodontic treatment with clear aligners and fixed appliances: a cone beam computed tomography study. Prog Orthod. 2020 Jan 6;21(1):1. doi: 10.1186/s40510-019-0301-1.
- Results publication: PubMed 23762314Lacruz RS, de Castro JM, Martinon-Torres M, O'Higgins P, Paine ML, Carbonell E, Arsuaga JL, Bromage TG. Facial morphogenesis of the earliest europeans. PLoS One. 2013 Jun 6;8(6):e65199. doi: 10.1371/journal.pone.0065199. Print 2013.
- Results publication: PubMed 26629473Zhang XJ, He L, Guo HM, Tian J, Bai YX, Li S. Integrated three-dimensional digital assessment of accuracy of anterior tooth movement using clear aligners. Korean J Orthod. 2015 Nov;45(6):275-81. doi: 10.4041/kjod.2015.45.6.275. Epub 2015 Nov 20.
- Results publication: PubMed 30627583Sfondrini MF, Gandini P, Castroflorio T, Garino F, Mergati L, D'Anca K, Trovati F, Scribante A. Buccolingual Inclination Control of Upper Central Incisors of Aligners: A Comparison with Conventional and Self-Ligating Brackets. Biomed Res Int. 2018 Nov 29;2018:9341821. doi: 10.1155/2018/9341821. eCollection 2018.
- Results publication: PubMed 33916462Tartaglia GM, Mapelli A, Maspero C, Santaniello T, Serafin M, Farronato M, Caprioglio A. Direct 3D Printing of Clear Orthodontic Aligners: Current State and Future Possibilities. Materials (Basel). 2021 Apr 5;14(7):1799. doi: 10.3390/ma14071799.
- Individual participant dataSharing planned: No
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.
Rim M Fathalla, PhD of Orthodontics principal investigator
Suez Canal University
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Direct printed aligners in people with Effect of Direct Printed Aligners on Root Torque, run by Suez Canal University at 3 sites in Egypt.
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 4 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Egypt. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Rim M Fathalla, PhD of Orthodontics (00201222726567, rim_fathalla@dent.suez.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the efficacy of direct 3D printed aligners in achieving the planned root torque of upper and lower incisors . (time frame: 9-12 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 NCT07273552, which also lists 6 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 9 Dec 2025.