CLASS II DIVISION 1 MALOCCLUSIONNCT07744685
Root Shortening With Three Methods of Upper Front Teeth Retraction
A study testing Bidimensional Bracket System, Hybrid Dual-Section Archwire and Conventional Sliding Mechanics in people with CLASS II DIVISION 1 MALOCCLUSION, run by Damascus University at 1 site in Syria.
Trial summary
External apical root resorption is a possible side effect of fixed orthodontic treatment, particularly in the upper front teeth. This randomized clinical trial was conducted to compare the amount and timing of root resorption associated with three different methods of retracting the upper anterior teeth using… Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- Bidimensional Bracket System, Hybrid Dual-Section Archwire and Conventional Sliding Mechanics
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSyria
- Study dates
- 2 Jul 2025to 28 Jun 2026
- 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 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-30 years.
- Class II Division 1 dental malocclusion according to Angle classification
- Mild-to-moderate skeletal Class II discrepancy, with an ANB angle greater than 4° and not exceeding 7°.
- Overjet ranging from 5 to 9 mm.
- Presence of all six maxillary anterior teeth.
- Maxillary anterior teeth fully erupted and with complete root formation.
Who cannot join
- Patients with previous orthodontic treatment.
- Missing permanent maxillary teeth.
- Active periodontal disease.
- History of trauma to any maxillary anterior tooth.
- Previous endodontic treatment of any maxillary anterior tooth.
- Periapical pathology involving any maxillary anterior tooth.
- Extensive coronal restorations that could interfere with crown-length measurement.
- Radiographic evidence of pre-existing root resorption before orthodontic treatment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Apical Root Resorption in Three Miniscrew-Supported Maxillary En-Masse Retraction Mechanics: A Randomized Controlled Trial
External apical root resorption is a possible side effect of fixed orthodontic treatment, particularly in the upper front teeth. This randomized clinical trial was conducted to compare the amount and timing of root resorption associated with three different methods of retracting the upper anterior teeth using miniscrew anchorage. Sixty adult patients with Class II Division 1 malocclusion who required extraction of the upper first premolars were randomly allocated to one of three groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group. In all groups, the six upper anterior teeth were retracted together with the support of orthodontic miniscrews. Panoramic radiographs were obtained before treatment, after completion of leveling and alignment, and after completion of en-masse retraction. Root and crown lengths were measured on these radiographs to estimate external apical root resorption during the leveling and alignment phase, during the retraction phase, and over the complete observation period. The study also compared the pattern of resorption among the upper canines, lateral incisors, and central incisors.
Read the detailed description
Orthodontic camouflage treatment of adult patients with Class II Division 1 malocclusion frequently involves extraction of the maxillary first premolars followed by retraction of the upper anterior teeth. Temporary orthodontic miniscrews can provide skeletal anchorage during this stage and allow the six maxillary anterior teeth to be retracted together as one unit. Although these mechanics are widely used, the anterior teeth remain exposed to orthodontic forces during both the initial leveling and alignment phase and the subsequent retraction phase. External apical root resorption is therefore an important biological safety outcome that should be evaluated throughout treatment rather than only after space closure has been completed.
This single-center, three-arm, parallel-group randomized clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Sixty adult patients with Class II Division 1 malocclusion who required extraction-based orthodontic camouflage treatment were allocated equally to one of three treatment groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group.
The three approaches differed in the relationship between the anterior brackets and the working archwire. The bidimensional approach used smaller anterior bracket slots with larger posterior slots. The hybrid dual-section approach used a customized archwire with different anterior and posterior cross-sections, while the conventional group used a continuous archwire with a uniform cross-section. These mechanical differences may influence archwire engagement, force expression, and the distribution of forces applied to the roots of the maxillary anterior teeth. Their possible effect on external apical root resorption therefore required direct clinical comparison.
All participants underwent bilateral extraction of the maxillary first premolars, fixed-appliance leveling and alignment, and miniscrew-supported en-masse retraction of the six maxillary anterior teeth. The same general treatment stages and skeletal anchorage concept were used in all groups, while the bracket-slot and archwire configurations varied according to group allocation. Retraction continued until an acceptable overjet and a Class I canine relationship were achieved. Participants were reviewed regularly throughout treatment, and miniscrew-related or other treatment-associated adverse events were recorded.
Digital panoramic radiographs were obtained before orthodontic treatment, at the end of leveling and alignment immediately before retraction, and after completion of en-masse retraction. The maxillary central incisors, lateral incisors, and canines on both sides were assessed individually. Crown length was used as a stable reference to correct for differences in radiographic magnification between time points.
The study was designed to determine whether the three treatment approaches were associated with different amounts of external apical root resorption and to identify the treatment phase during which root shortening occurred. Resorption was therefore evaluated separately during leveling and alignment, during en-masse retraction, and across the complete observation period. This phase-specific design was intended to avoid attributing all root changes detected at the end of retraction to the retraction mechanics alone.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- Bidimensional Bracket System, Hybrid Dual-Section Archwire, Conventional Sliding Mechanics
- Medical subject headings
- Malocclusion, Angle Class II
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bidimensional Bracket SystemProcedure or surgery
Fixed orthodontic treatment will be performed using 0.018-inch slot brackets from canine to canine and 0.022-inch slot brackets on the posterior teeth. After leveling and alignment, en-masse retraction will be performed on a 0.018 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.
Hybrid Dual-Section ArchwireProcedure or surgery
Fixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out using a customized stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior section and 0.016 × 0.022-inch posterior sections, with the transitions located distal to the maxillary canines. Bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g per side will be used.
Conventional Sliding MechanicsProcedure or surgery
Fixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out on a continuous 0.019 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side.
| Study group | Role | What they receive |
|---|---|---|
| Bidimensional Bracket Group | Experimental | Participants will be treated using a bidimensional fixed orthodontic appliance during leveling, alignment, and en-masse retraction. Receives: Procedure: Bidimensional Bracket System |
| Hybrid Dual-Section Archwire Group | Experimental | Participants will be treated using a hybrid dual-section archwire during miniscrew-supported en-masse retraction. Receives: Procedure: Hybrid Dual-Section Archwire |
| Conventional Sliding Mechanics Group | Active comparator | Participants will be treated using conventional fixed orthodontic sliding mechanics during miniscrew-supported en-masse retraction Receives: Procedure: Conventional Sliding Mechanics |
What is being measured
The primary outcome is the main question the study is designed to answer.
External Apical Root Resorption of the Maxillary Anterior Teeth
External apical root resorption was assessed separately for the six maxillary anterior teeth by measuring changes in corrected root length on digital panoramic radiographs using ImageJ software. Crown length was used as a stable reference to correct for differences in radiographic magnification. Root resorption was expressed in millimeters, and the total amount was calculated directly from the initial and final radiographs rather than by adding the interval measurements.
Measured: Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start2 Jul 2025
- Primary completion23 Jun 2026
- Study completion28 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for CLASS II DIVISION 1 MALOCCLUSIONStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad Younis Hajeer, Study director, Department of Orthodontics, Faculty of Dentistry, University of DamascusAbdulmalek M. H. Almasri, Principal investigator, Department of Orthodontics, Faculty of Dentistry, University of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07744685
- Sponsor's protocol ID
- UDDS-2026-Ortho-03
- Status last verified
- Jul 2026
- First submitted
- 23 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Linge BO, Linge L. Apical root resorption in upper anterior teeth. Eur J Orthod. 1983 Aug;5(3):173-83. doi: 10.1093/ejo/5.3.173. No abstract available.
PubMed 6578039Levander E, Malmgren O. Evaluation of the risk of root resorption during orthodontic treatment: a study of upper incisors. Eur J Orthod. 1988 Feb;10(1):30-8. doi: 10.1093/ejo/10.1.30. No abstract available.
PubMed 3162877Futyma-Gabka K, Rozylo-Kalinowska I, Piskorz M, Bis E, Borek W. Evaluation of root resorption in maxillary anterior teeth during orthodontic treatment with a fixed appliance based on panoramic radiographs. Pol J Radiol. 2022 Oct 5;87:e545-e548. doi: 10.5114/pjr.2022.120512. eCollection 2022.
PubMed 36420127Dudic A, Giannopoulou C, Leuzinger M, Kiliaridis S. Detection of apical root resorption after orthodontic treatment by using panoramic radiography and cone-beam computed tomography of super-high resolution. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):434-7. doi: 10.1016/j.ajodo.2008.10.014.
PubMed 19361727Artun J, Smale I, Behbehani F, Doppel D, Van't Hof M, Kuijpers-Jagtman AM. Apical root resorption six and 12 months after initiation of fixed orthodontic appliance therapy. Angle Orthod. 2005 Nov;75(6):919-26. doi: 10.1043/0003-3219(2005)75[919:ARRSAM]2.0.CO;2.
PubMed 16448232
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Apical Root Resorption in Three Miniscrew-Supported Maxillary En-Masse Retraction Mechanics: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07744685
- Acronym / sponsor ID
- UDDS-2026-Ortho-03
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 2 Jul 2025 (actual)
- Primary completion
- 23 Jun 2026 (actual)
- Study completion
- 28 Jun 2026 (actual)
- First posted
- 4 Aug 2026 (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.
External apical root resorption is a possible side effect of fixed orthodontic treatment, particularly in the upper front teeth. This randomized clinical trial was conducted to compare the amount and timing of root resorption associated with three different methods of retracting the upper anterior teeth using miniscrew anchorage. Sixty adult patients with Class II Division 1 malocclusion who required extraction of the upper first premolars were randomly allocated to one of three groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group. In all groups, the six upper anterior teeth were retracted together with the support of orthodontic miniscrews. Panoramic radiographs were obtained before treatment, after completion of leveling and alignment, and after completion of en-masse retraction. Root and crown lengths were measured on these radiographs to estimate external apical root resorption during the leveling and alignment phase, during the retraction phase, and over the complete observation period. The study also compared the pattern of resorption among the upper canines, lateral incisors, and central incisors.
Detailed description
Orthodontic camouflage treatment of adult patients with Class II Division 1 malocclusion frequently involves extraction of the maxillary first premolars followed by retraction of the upper anterior teeth. Temporary orthodontic miniscrews can provide skeletal anchorage during this stage and allow the six maxillary anterior teeth to be retracted together as one unit. Although these mechanics are widely used, the anterior teeth remain exposed to orthodontic forces during both the initial leveling and alignment phase and the subsequent retraction phase. External apical root resorption is therefore an important biological safety outcome that should be evaluated throughout treatment rather than only after space closure has been completed.
This single-center, three-arm, parallel-group randomized clinical trial was conducted at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Sixty adult patients with Class II Division 1 malocclusion who required extraction-based orthodontic camouflage treatment were allocated equally to one of three treatment groups: a bidimensional bracket group, a hybrid dual-section archwire group, or a conventional sliding mechanics group.
The three approaches differed in the relationship between the anterior brackets and the working archwire. The bidimensional approach used smaller anterior bracket slots with larger posterior slots. The hybrid dual-section approach used a customized archwire with different anterior and posterior cross-sections, while the conventional group used a continuous archwire with a uniform cross-section. These mechanical differences may influence archwire engagement, force expression, and the distribution of forces applied to the roots of the maxillary anterior teeth. Their possible effect on external apical root resorption therefore required direct clinical comparison.
All participants underwent bilateral extraction of the maxillary first premolars, fixed-appliance leveling and alignment, and miniscrew-supported en-masse retraction of the six maxillary anterior teeth. The same general treatment stages and skeletal anchorage concept were used in all groups, while the bracket-slot and archwire configurations varied according to group allocation. Retraction continued until an acceptable overjet and a Class I canine relationship were achieved. Participants were reviewed regularly throughout treatment, and miniscrew-related or other treatment-associated adverse events were recorded.
Digital panoramic radiographs were obtained before orthodontic treatment, at the end of leveling and alignment immediately before retraction, and after completion of en-masse retraction. The maxillary central incisors, lateral incisors, and canines on both sides were assessed individually. Crown length was used as a stable reference to correct for differences in radiographic magnification between time points.
The study was designed to determine whether the three treatment approaches were associated with different amounts of external apical root resorption and to identify the treatment phase during which root shortening occurred. Resorption was therefore evaluated separately during leveling and alignment, during en-masse retraction, and across the complete observation period. This phase-specific design was intended to avoid attributing all root changes detected at the end of retraction to the retraction mechanics alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Bidimensional Bracket Group | Experimental | Procedure: Bidimensional Bracket SystemParticipants will be treated using a bidimensional fixed orthodontic appliance during leveling, alignment, and en-masse retraction. |
| Hybrid Dual-Section Archwire Group | Experimental | Procedure: Hybrid Dual-Section ArchwireParticipants will be treated using a hybrid dual-section archwire during miniscrew-supported en-masse retraction. |
| Conventional Sliding Mechanics Group | Active comparator | Procedure: Conventional Sliding MechanicsParticipants will be treated using conventional fixed orthodontic sliding mechanics during miniscrew-supported en-masse retraction |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-30 years.
- Class II Division 1 dental malocclusion according to Angle classification
- Mild-to-moderate skeletal Class II discrepancy, with an ANB angle greater than 4° and not exceeding 7°.
- Overjet ranging from 5 to 9 mm.
- Presence of all six maxillary anterior teeth.
Key exclusion criteria (8 listed)
- Patients with previous orthodontic treatment.
- Missing permanent maxillary teeth.
- Active periodontal disease.
- History of trauma to any maxillary anterior tooth.
- Previous endodontic treatment of any maxillary anterior tooth.
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 |
|---|---|---|
| Bidimensional Bracket SystemFixed orthodontic treatment will be performed using 0.018-inch slot brackets from canine to canine and 0.022-inch slot brackets on the posterior teeth. After leveling and alignment, en-masse retraction will be performed on a 0.018 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side. | Procedure or surgery | Bidimensional Bracket Group |
| Hybrid Dual-Section ArchwireFixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out using a customized stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior section and 0.016 × 0.022-inch posterior sections, with the transitions located distal to the maxillary canines. Bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g per side will be used. | Procedure or surgery | Hybrid Dual-Section Archwire Group |
| Conventional Sliding MechanicsFixed orthodontic treatment will be performed using 0.022-inch slot brackets. En-masse retraction will be carried out on a continuous 0.019 × 0.025-inch stainless-steel archwire using bilateral orthodontic miniscrews and nickel-titanium closed-coil springs delivering 250 g of force per side. | Procedure or surgery | Conventional Sliding Mechanics Group |
Primary outcome
External Apical Root Resorption of the Maxillary Anterior Teeth
Time frame: Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 12 months.
External apical root resorption was assessed separately for the six maxillary anterior teeth by measuring changes in corrected root length on digital panoramic radiographs using ImageJ software. Crown length was used as a stable reference to correct for differences in radiographic magnification. Root resorption was expressed in millimeters, and the total amount was calculated directly from the initial and final radiographs rather than by adding the interval measurements.
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 4 Aug 2026.
- Background: PubMed 6578039Linge BO, Linge L. Apical root resorption in upper anterior teeth. Eur J Orthod. 1983 Aug;5(3):173-83. doi: 10.1093/ejo/5.3.173. No abstract available.
- Background: PubMed 3162877Levander E, Malmgren O. Evaluation of the risk of root resorption during orthodontic treatment: a study of upper incisors. Eur J Orthod. 1988 Feb;10(1):30-8. doi: 10.1093/ejo/10.1.30. No abstract available.
- Background: PubMed 36420127Futyma-Gabka K, Rozylo-Kalinowska I, Piskorz M, Bis E, Borek W. Evaluation of root resorption in maxillary anterior teeth during orthodontic treatment with a fixed appliance based on panoramic radiographs. Pol J Radiol. 2022 Oct 5;87:e545-e548. doi: 10.5114/pjr.2022.120512. eCollection 2022.
- Background: PubMed 19361727Dudic A, Giannopoulou C, Leuzinger M, Kiliaridis S. Detection of apical root resorption after orthodontic treatment by using panoramic radiography and cone-beam computed tomography of super-high resolution. Am J Orthod Dentofacial Orthop. 2009 Apr;135(4):434-7. doi: 10.1016/j.ajodo.2008.10.014.
- Background: PubMed 16448232Artun J, Smale I, Behbehani F, Doppel D, Van't Hof M, Kuijpers-Jagtman AM. Apical root resorption six and 12 months after initiation of fixed orthodontic appliance therapy. Angle Orthod. 2005 Nov;75(6):919-26. doi: 10.1043/0003-3219(2005)75[919:ARRSAM]2.0.CO;2.
- 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
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Abdulmalek M. H. Almasri principal investigator
Department of Orthodontics, 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 Bidimensional Bracket System, Hybrid Dual-Section Archwire and Conventional Sliding Mechanics in people with CLASS II DIVISION 1 MALOCCLUSION, 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 6 inclusion and 8 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 4 Aug 2026. 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?
External Apical Root Resorption of the Maxillary Anterior Teeth (time frame: Time 0: before the initiation of orthodontic treatment; Time 1: after the leveling and alignment stage, which occurs within an average of four months, Time Final: after the en-masse retraction stage, which occurs wihtin an averag 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 NCT07744685, which also lists 5 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 4 Aug 2026.