Malocclusion Class IINCT07664215
A Novel Bi-dimensional Archwire for Miniscrew-supported En-masse Retraction
A study testing Bi-dimensional archwire in people with Malocclusion Class II and CLASS II DIVISION 1 MALOCCLUSION, run by Damascus University at 1 site in Syria.
Trial summary
This study aims to provide a preliminary clinical evaluation of a novel bi-dimensional archwire used during miniscrew-supported en-masse retraction of the maxillary anterior teeth. Read more about this study
- Who is it for?
- Ages 18 to 28 years
- Conditions the study is for
- Malocclusion Class II, CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- Bi-dimensional archwire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteSyria
- Study dates
- 1 Jul 2025to 1 May 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 28 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18-28 years with skeletal Class II malocclusion (ANB angle 5°-7°)
- Class II Division 1 dental malocclusion according to Angle classification
- An average or vertical facial growth pattern
- A treatment plan requiring extraction of the maxillary first premolars
- A need for maxillary anterior en-masse retraction
- The presence of all permanent maxillary teeth except the third molars
Who cannot join
- Patients with previous orthodontic treatment,
- Craniofacial anomalies, systemic diseases affecting bone metabolism
- Active periodontal disease
- Poor oral hygiene
- Missing maxillary permanent teeth, or were using
- The use of medications known to influence bone metabolism
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, DM20AM19
About this study
Official title: Preliminary Clinical Evaluation of a Novel Bi-dimensional Archwire During Miniscrew-Supported En-masse Retraction of the Maxillary Anterior Teeth
This study aims to provide a preliminary clinical evaluation of a novel bi-dimensional archwire used during miniscrew-supported en-masse retraction of the maxillary anterior teeth. Adult patients with Class II Division 1 malocclusion requiring extraction of the maxillary first premolars will be screened at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible participants will receive fixed orthodontic treatment followed by en-masse retraction using a custom-made laser-welded bi-dimensional stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments. Retraction will be supported by orthodontic miniscrews and nickel-titanium closed-coil springs. The main outcome will be the monthly rate of maxillary anterior retraction assessed on three-dimensional digital dental models. A secondary outcome will be the change in maxillary incisor torque assessed on lateral cephalometric radiographs. This pilot study is intended to generate preliminary clinical data regarding the feasibility and performance of this novel archwire design.
Read the detailed description
This study was designed as a prospective single-arm pilot clinical trial to provide an initial clinical evaluation of a novel bi-dimensional archwire specifically developed for miniscrew-supported en-masse retraction of the maxillary anterior teeth. In adult orthodontic patients requiring extraction-based treatment, effective space closure depends not only on anchorage control, but also on the ability of the active retraction system to maintain acceptable control of the maxillary incisors during sliding mechanics. Conventional continuous rectangular stainless-steel archwires provide rigidity, but they may still be associated with frictional resistance, wire deformation, and incomplete torque control during retraction.
The archwire investigated in this study was newly developed as a single continuous stainless-steel assembly composed of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments joined by laser welding. The design was intended to combine greater anterior stiffness, to support better torque control of the maxillary incisors, with reduced posterior friction and binding during sliding mechanics. The intervention was applied under direct skeletal anchorage using self-drilling orthodontic miniscrews inserted bilaterally between the maxillary second premolars and first molars. Retraction was performed using nickel-titanium closed-coil springs delivering approximately 250 g of force per side.
Eligible participants were adult patients with skeletal Class II malocclusion and Class II Division 1 dental malocclusion who required extraction of the maxillary first premolars and en-masse retraction of the maxillary anterior teeth as part of their treatment plan. After leveling and alignment, the novel bi-dimensional archwire was inserted and the retraction phase was initiated. Participants were followed prospectively until completion of the en-masse retraction phase.
The primary outcome of the study was the monthly rate of maxillary anterior en-masse retraction assessed on three-dimensional digital dental models. The secondary outcome was the change in maxillary incisor torque measured on standardized lateral cephalometric radiographs using the bracket-archwire angle. This pilot trial was undertaken to determine whether this newly developed archwire could function as a clinically feasible biomechanical option and to generate preliminary outcome estimates for future randomized controlled trials.
- Being tested
- Bi-dimensional archwire
- Keywords
- Class II division 1, protrusion, Bi-dimensional archwire, retraction, upper anterior teeth retraction, en masse retraction
- 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.
Bi-dimensional archwireProcedure or surgery
The retraction procedure is going to be conducted using a bi-dimensional archwire which is a single continuous stainless-steel assembly composed of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments joined by laser welding.
| Study group | Role | What they receive |
|---|---|---|
| Bi-dimensional archwire | Experimental | Participants will be treated using a novel bi-dimensional stainless-steel archwire during miniscrew-supported en-masse retraction of the maxillary anterior teeth Receives: Procedure: Bi-dimensional archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the monthly rate of maxillary anterior en-masse retraction
The amount of maxillary anterior retraction is assessed on three-dimensional digital dental models using the distance between the incisal edge of the maxillary central incisors and the medial point of the third palatal rugae as a stable intraoral reference. The monthly retraction rate is calculated in millimeters per month by dividing the amount of anterior retraction by the corresponding duration of the retraction interval.
Measured: Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.
Secondary outcomes (1)
Change in maxillary incisor torque
Maxillary incisor torque is assessed on standardized lateral cephalometric radiographs using the bracket-archwire angle. A tangent is drawn along the base of the maxillary central incisor bracket, and another tangent is drawn parallel to and superimposed on the working archwire. The obtuse angle formed between the two tangents is measured, and the actual torque value is calculated by subtracting 90° from this angle. The change in torque is determined by comparing the measurements recorded at T0 and T1.
Measured: Time 0: completion of leveling and alignment stage which is expected to occur within three months, and Time Final: completion of en-masse retraction stage which occurs within 9 - 10 months following the end of the leveling and alignment stage.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start1 Jul 2025
- Primary completion27 Apr 2026
- Study completion1 May 2026
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 Malocclusion Class 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Abdulmalek M. H. Almasri, DDS, Principal investigator, Damascus University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664215
- Sponsor's protocol ID
- UDDS-2026-Ortho-4
- Status last verified
- Jun 2026
- First submitted
- 13 Jun 2026
- Last updated
- 24 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gnaneswar SM, Sridhar P. Comparison of dual-dimensional and rectangular wires in terms of space closure and anchorage loss during retraction with miniimplants: A prospective clinical study. J Dent Res Dent Clin Dent Prospects. 2020 Winter;14(1):54-60. doi: 10.34172/joddd.2020.008.
PubMed 32454959Hamanaka R, Cantarella D, Lombardo L, Karanxha L, Del Fabbro M, Siciliani G, Yoshida N. Dual-section versus conventional archwire for en-masse retraction of anterior teeth with direct skeletal anchorage: a finite element analysis. BMC Oral Health. 2021 Feb 25;21(1):87. doi: 10.1186/s12903-021-01443-0.
PubMed 33632190Li Y, Tang N, Xu Z, Feng X, Yang L, Zhao Z. Bidimensional techniques for stronger anterior torque control in extraction cases: a combined clinical and typodont study. Angle Orthod. 2012 Jul;82(4):715-22. doi: 10.2319/082811-550.1. Epub 2011 Dec 8.
PubMed 22149540Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.
PubMed 18617099Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
PubMed 23787192Almasri AMH, Hajeer MY, Burhan AS, Jaber S. Preliminary Clinical Case Series for Evaluation of a Novel Bi-Dimensional Archwire During Miniscrew-Supported En-Masse Retraction of the Maxillary Anterior Teeth. Reports (MDPI). 2026 Oct 2;9(4):334. doi: 10.3390/reports9040334.
PubMed 42924786
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preliminary Clinical Evaluation of a Novel Bi-dimensional Archwire During Miniscrew-Supported En-masse Retraction of the Maxillary Anterior Teeth
- ClinicalTrials.gov ID
- NCT07664215
- Acronym / sponsor ID
- UDDS-2026-Ortho-4
- Keywords
- Class II division 1, protrusion, Bi-dimensional archwire, retraction, upper anterior teeth retraction, en masse retraction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 6 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- 27 Apr 2026 (actual)
- Study completion
- 1 May 2026 (actual)
- First posted
- 24 Jun 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.
This study aims to provide a preliminary clinical evaluation of a novel bi-dimensional archwire used during miniscrew-supported en-masse retraction of the maxillary anterior teeth. Adult patients with Class II Division 1 malocclusion requiring extraction of the maxillary first premolars will be screened at the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible participants will receive fixed orthodontic treatment followed by en-masse retraction using a custom-made laser-welded bi-dimensional stainless-steel archwire consisting of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments. Retraction will be supported by orthodontic miniscrews and nickel-titanium closed-coil springs. The main outcome will be the monthly rate of maxillary anterior retraction assessed on three-dimensional digital dental models. A secondary outcome will be the change in maxillary incisor torque assessed on lateral cephalometric radiographs. This pilot study is intended to generate preliminary clinical data regarding the feasibility and performance of this novel archwire design.
Detailed description
This study was designed as a prospective single-arm pilot clinical trial to provide an initial clinical evaluation of a novel bi-dimensional archwire specifically developed for miniscrew-supported en-masse retraction of the maxillary anterior teeth. In adult orthodontic patients requiring extraction-based treatment, effective space closure depends not only on anchorage control, but also on the ability of the active retraction system to maintain acceptable control of the maxillary incisors during sliding mechanics. Conventional continuous rectangular stainless-steel archwires provide rigidity, but they may still be associated with frictional resistance, wire deformation, and incomplete torque control during retraction.
The archwire investigated in this study was newly developed as a single continuous stainless-steel assembly composed of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments joined by laser welding. The design was intended to combine greater anterior stiffness, to support better torque control of the maxillary incisors, with reduced posterior friction and binding during sliding mechanics. The intervention was applied under direct skeletal anchorage using self-drilling orthodontic miniscrews inserted bilaterally between the maxillary second premolars and first molars. Retraction was performed using nickel-titanium closed-coil springs delivering approximately 250 g of force per side.
Eligible participants were adult patients with skeletal Class II malocclusion and Class II Division 1 dental malocclusion who required extraction of the maxillary first premolars and en-masse retraction of the maxillary anterior teeth as part of their treatment plan. After leveling and alignment, the novel bi-dimensional archwire was inserted and the retraction phase was initiated. Participants were followed prospectively until completion of the en-masse retraction phase.
The primary outcome of the study was the monthly rate of maxillary anterior en-masse retraction assessed on three-dimensional digital dental models. The secondary outcome was the change in maxillary incisor torque measured on standardized lateral cephalometric radiographs using the bracket-archwire angle. This pilot trial was undertaken to determine whether this newly developed archwire could function as a clinically feasible biomechanical option and to generate preliminary outcome estimates for future randomized controlled trials.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Bi-dimensional archwire | Experimental | Procedure: Bi-dimensional archwireParticipants will be treated using a novel bi-dimensional stainless-steel archwire during miniscrew-supported en-masse retraction of the maxillary anterior teeth |
Who may qualify
- Ages
- 18 to 28 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults aged 18-28 years with skeletal Class II malocclusion (ANB angle 5°-7°)
- Class II Division 1 dental malocclusion according to Angle classification
- An average or vertical facial growth pattern
- A treatment plan requiring extraction of the maxillary first premolars
- A need for maxillary anterior en-masse retraction
Key exclusion criteria (6 listed)
- Patients with previous orthodontic treatment,
- Craniofacial anomalies, systemic diseases affecting bone metabolism
- Active periodontal disease
- Poor oral hygiene
- Missing maxillary permanent teeth, or were using
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 |
|---|---|---|
| Bi-dimensional archwireThe retraction procedure is going to be conducted using a bi-dimensional archwire which is a single continuous stainless-steel assembly composed of a 0.019 × 0.025-inch anterior segment and 0.016 × 0.022-inch posterior segments joined by laser welding. | Procedure or surgery | Bi-dimensional archwire |
Primary outcome
Change in the monthly rate of maxillary anterior en-masse retraction
Time frame: Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.
The amount of maxillary anterior retraction is assessed on three-dimensional digital dental models using the distance between the incisal edge of the maxillary central incisors and the medial point of the third palatal rugae as a stable intraoral reference. The monthly retraction rate is calculated in millimeters per month by dividing the amount of anterior retraction by the corresponding duration of the retraction interval.
1 secondary outcome
Change in maxillary incisor torque
Time frame: Time 0: completion of leveling and alignment stage which is expected to occur within three months, and Time Final: completion of en-masse retraction stage which occurs within 9 - 10 months following the end of the leveling and alignment stage.
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 24 Jun 2026.
- Background: PubMed 32454959Gnaneswar SM, Sridhar P. Comparison of dual-dimensional and rectangular wires in terms of space closure and anchorage loss during retraction with miniimplants: A prospective clinical study. J Dent Res Dent Clin Dent Prospects. 2020 Winter;14(1):54-60. doi: 10.34172/joddd.2020.008.
- Background: PubMed 33632190Hamanaka R, Cantarella D, Lombardo L, Karanxha L, Del Fabbro M, Siciliani G, Yoshida N. Dual-section versus conventional archwire for en-masse retraction of anterior teeth with direct skeletal anchorage: a finite element analysis. BMC Oral Health. 2021 Feb 25;21(1):87. doi: 10.1186/s12903-021-01443-0.
- Background: PubMed 22149540Li Y, Tang N, Xu Z, Feng X, Yang L, Zhao Z. Bidimensional techniques for stronger anterior torque control in extraction cases: a combined clinical and typodont study. Angle Orthod. 2012 Jul;82(4):715-22. doi: 10.2319/082811-550.1. Epub 2011 Dec 8.
- Background: PubMed 18617099Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.
- Background: PubMed 23787192Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
- Derived from this study: PubMed 42924786Almasri AMH, Hajeer MY, Burhan AS, Jaber S. Preliminary Clinical Case Series for Evaluation of a Novel Bi-Dimensional Archwire During Miniscrew-Supported En-Masse Retraction of the Maxillary Anterior Teeth. Reports (MDPI). 2026 Oct 2;9(4):334. doi: 10.3390/reports9040334.
- 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.
Abdulmalek M. H. Almasri, DDS principal investigator
Damascus University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bi-dimensional archwire in people with Malocclusion Class II and 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 6 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 24 Jun 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?
Change in the monthly rate of maxillary anterior en-masse retraction (time frame: Time 0: completion of leveling and alignment which happens within three months); Times 1, 2, 3, 4, 5 after one, two, three, four, and five months following the end of the leveling and alignment stage; Time Final: at the end of the retraction stage.). 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 NCT07664215, 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 24 Jun 2026.