CLASS II DIVISION 1 MALOCCLUSIONNCT07243509
Evaluating the Efficacy of the Sliding Mechanisms on Round-section Arch Wire
A study testing Round-cross-section archwire and Rectangular-cross-section archwire in people with CLASS II DIVISION 1 MALOCCLUSION, run by Damascus University at 1 site in Syria.
Trial summary
Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that… Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- CLASS II DIVISION 1 MALOCCLUSION
- What is being tested?
- Round-cross-section archwire and Rectangular-cross-section archwire
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteSyria
- Study dates
- 7 Jul 2023to 15 Jul 2024
- 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
- Mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°),
- A normal to slightly increased vertical growth pattern (Björk's sum > 390° and < 406°),
- An overjet of 5-10 mm.
- A further prerequisite was a camouflage treatment plan involving the extraction of the maxillary first premolars.
Who cannot join
- the presence of no systemic health issues or any systemic condition known to influence the rate of orthodontic tooth movement,
- active periodontal disease,
- absence of any permanent teeth in the upper arch (excluding third molars),
- crowding of 4 mm or greater,
- inadequate oral hygiene.
Trial locations and contacts
1 site in 1 country.
Syria1 site
Orthodontics Department, Faculty of Dentistry
Damascus, Rif-dimashq Governorate, DM20AM19
About this study
Official title: Evaluation of the Efficacy of Sliding Mechanisms on Round Versus Rectangular Archwires in Canine Retraction After First Premolar Extraction in Class II Malocclusion: A Randomized Clinical Trial
Patients at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.
This study aims to compare two groups of patients with mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°), a normal to slightly increased vertical growth pattern (Björk's sum > 390° and < 406°), and an overjet of 5-10 mm. Experimental group: the patients in this group will be treated in the canine retraction phase with a sliding on a round-section archwire of 0.020 inch Control group: the patients in this group. Maxillary canine distalization was carried out using sliding mechanics on a 0.019 × 0.025-inch stainless steel archwire.
Read the detailed description
In adult Class II camouflage treatment, the extraction of the first premolars is followed by a two-phase retraction protocol, consisting of initial canine retraction and subsequent incisor retraction, which is a standard approach. However, this process often extends treatment duration up to 36 months, creating significant clinical challenges. Prolonged orthodontic therapy not only burdens patients but also increases the risk of complications such as dental caries, root resorption, and periodontal problems, emphasizing the need for more efficient treatment strategies.
To accelerate tooth movement, both surgical and non-surgical methods have been explored. Surgical interventions, including corticotomy, piezocision, flapless cortico-alveolar perforations, and periodontal accelerated osteogenic orthodontics, have shown promising results but remain invasive and less acceptable to patients. Consequently, non-surgical alternatives have gained attention, including low-level laser therapy, electrical stimulation, platelet-rich plasma injections, and mechanical innovations such as self-ligating brackets. Despite these advances, canine retraction remains biomechanically demanding due to its slow rate and the difficulty of controlling unwanted rotation and angulation.
Mechanically, rectangular archwires provide torque control but generate high friction at the bracket-wire interface, delaying canine movement. Round-section archwires, by contrast, reduce bracket-wall contact and friction, enabling smoother sliding mechanics, improved angulation control, and reduced anchorage strain. Despite these theoretical advantages, clinical evidence is scarce. The only notable study, by Hamid, was limited by methodological shortcomings, including a short four-week observation period and a lack of long-term data. Importantly, no clinical trial has systematically evaluated sliding mechanics using a 0.020-inch round archwire, leaving a critical gap in the literature.
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Being tested
- Round-cross-section archwire, Rectangular-cross-section archwire
- Keywords
- Canine retraction, acceleration of orthodontic tooth movement, Bidimensioanl archwire, 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.
Round-cross-section archwireProcedure or surgery
Canines will be retracted on an archwire with a diameter of 0.20 inches.
Rectangular-cross-section archwireProcedure or surgery
Canines will be retracted on an archwire with a diameter of 0.019 x 0.025-inch.
| Study group | Role | What they receive |
|---|---|---|
| Canine retraction on a round cross-section archwire | Experimental | The patients in this group will be treated by sliding on a round cross-section archwire of 0.020-inch diameter. Receives: Procedure: Round-cross-section archwire |
| Traditional canine retraction on a rectangular-cross-section archwire | Active comparator | The patients in this group will be treated using a sliding rectangular arch wire with a diameter of 0.019 × 0.025 inches. Receives: Procedure: Rectangular-cross-section archwire |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the Rate of Maxillary Canine Retraction
Canine displacement is measured by projecting the canine apex and the medial end of the third palatal ruga onto the mid-palatal plane; the linear distance between these points is recorded at each time point. Monthly retraction rates are calculated by dividing the change in displacement by the corresponding interval in months. For each subject, mean monthly rates for right and left canines are determined, and the cohort retraction rate is expressed as the average across all patients.
Measured: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Secondary outcomes (4)
Change in Canine Rotation
Canine rotation is defined as the angle between the mid-palatal plane and the line connecting the mesial and distal ridges of the canine crown. The angular shift between consecutive intervals is divided by the interval duration to yield monthly rotation rates. Per-subject averages for right and left canines are computed and then averaged across participants.
Measured: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Change in Anchorage Loss
Anchorage loss is assessed by measuring first-molar movement relative to the third palatal ruga. Linear distances between the maxillary first molar fossa and the medial end of the third palatal ruga, both projected onto the mid-palatal plane, are recorded at T0-TF. Monthly drift rates are calculated similarly to canine retraction, averaged per side, and then across the cohort.
Measured: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Change in Canine Angulation
Canine angulation change is evaluated at T0 and TF via standardized lateral cephalograms. To enhance measurement accuracy, stainless-steel reference wires (0.021 × 0.025 mm; 12 mm apical extension) are affixed to each canine: circular-ended on the right, triangular-ended on the left. Radiographs are analyzed in ImageJ (NIH, USA). Angulation is defined as the angle between each wire and the Sella-Nasion plane.
Measured: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Root Resorption of the Canine
External apical root resorption (EARR) is assessed by comparing maxillary canine root lengths on panoramic radiographs taken at T0 and TF. Baseline root length is recorded at T0; at TF, the reduction in length is measured, and the percentage of resorption is calculated. All measurements are performed in ImageJ (National Institutes of Health, Bethesda, Maryland, USA).
Measured: T0: T0: 10 minutes before starting canine retraction stage; TF: At completion of canine retraction (expected to happen within 3 - 5 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2025
- Study start7 Jul 2023
- Primary completion1 Apr 2024
- Study completion15 Jul 2024
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 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
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mohammad N. Kheshfeh, DDS, MSc, Principal investigator, Department of Orthodontics, University of DamascusMohammad Younis Hajeer, DDS, MSc, PhD, Study chair, Department of Orthodontics, University of DamascusAhamd S. Burhan, DDS, MSc, PhD, Study director, Department of Orthodontics, Unviersity of Damascus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07243509
- Sponsor's protocol ID
- UDDS-2025-Ortho-10
- Status last verified
- Nov 2025
- First submitted
- 14 Nov 2025
- Last updated
- 24 Nov 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mavreas D, Athanasiou AE. Factors affecting the duration of orthodontic treatment: a systematic review. Eur J Orthod. 2008 Aug;30(4):386-95. doi: 10.1093/ejo/cjn018.
PubMed 18678758Al-Ibrahim HM, Hajeer MY, Burhan AS, Sultan K, Ajaj MA, Mahaini L. The Efficacy of Accelerating Orthodontic Tooth Movement by Combining Self-Ligating Brackets With One or More Acceleration Methods: A Systematic Review. Cureus. 2022 Dec 23;14(12):e32879. doi: 10.7759/cureus.32879. eCollection 2022 Dec.
PubMed 36578856Kusy RP, Whitley JQ. Influence of archwire and bracket dimensions on sliding mechanics: derivations and determinations of the critical contact angles for binding. Eur J Orthod. 1999 Apr;21(2):199-208. doi: 10.1093/ejo/21.2.199.
PubMed 10327744Southard TE, Marshall SD, Grosland NM. Friction does not increase anchorage loading. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):412-4. doi: 10.1016/j.ajodo.2006.09.037.
PubMed 17346599Tidy DC. Frictional forces in fixed appliances. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):249-54. doi: 10.1016/0889-5406(89)90462-9.
PubMed 2773871Kheshfeh MN, Hajeer MY, Alam MK, Al Hinnawi MF, Abou Hamed H. Evaluation of the efficacy of sliding mechanisms on round versus rectangular archwires in canine retraction after first premolar extraction in class II malocclusion: a randomized clinical trial. Prog Orthod. 2026 Jun 4;27(1):24. doi: 10.1186/s40510-026-00629-y.
PubMed 42240945
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy of Sliding Mechanisms on Round Versus Rectangular Archwires in Canine Retraction After First Premolar Extraction in Class II Malocclusion: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07243509
- Acronym / sponsor ID
- UDDS-2025-Ortho-10
- Conditions
- CLASS II DIVISION 1 MALOCCLUSION
- Keywords
- Canine retraction, acceleration of orthodontic tooth movement, Bidimensioanl archwire, Sliding mechanics
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 7 Jul 2023 (actual)
- Primary completion
- 1 Apr 2024 (actual)
- Study completion
- 15 Jul 2024 (actual)
- First posted
- 24 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 at the Orthodontic Department of the University of Damascus Dental School will be examined, and subjects who meet the inclusion criteria will be included. Then, initial diagnostic records (diagnostic gypsum models, internal and external oral photographs, and radiographic images) will be studied to ensure that the selection criteria are accurately matched.
This study aims to compare two groups of patients with mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°), a normal to slightly increased vertical growth pattern (Björk's sum > 390° and < 406°), and an overjet of 5-10 mm. Experimental group: the patients in this group will be treated in the canine retraction phase with a sliding on a round-section archwire of 0.020 inch Control group: the patients in this group. Maxillary canine distalization was carried out using sliding mechanics on a 0.019 × 0.025-inch stainless steel archwire.
Detailed description
In adult Class II camouflage treatment, the extraction of the first premolars is followed by a two-phase retraction protocol, consisting of initial canine retraction and subsequent incisor retraction, which is a standard approach. However, this process often extends treatment duration up to 36 months, creating significant clinical challenges. Prolonged orthodontic therapy not only burdens patients but also increases the risk of complications such as dental caries, root resorption, and periodontal problems, emphasizing the need for more efficient treatment strategies.
To accelerate tooth movement, both surgical and non-surgical methods have been explored. Surgical interventions, including corticotomy, piezocision, flapless cortico-alveolar perforations, and periodontal accelerated osteogenic orthodontics, have shown promising results but remain invasive and less acceptable to patients. Consequently, non-surgical alternatives have gained attention, including low-level laser therapy, electrical stimulation, platelet-rich plasma injections, and mechanical innovations such as self-ligating brackets. Despite these advances, canine retraction remains biomechanically demanding due to its slow rate and the difficulty of controlling unwanted rotation and angulation.
Mechanically, rectangular archwires provide torque control but generate high friction at the bracket-wire interface, delaying canine movement. Round-section archwires, by contrast, reduce bracket-wall contact and friction, enabling smoother sliding mechanics, improved angulation control, and reduced anchorage strain. Despite these theoretical advantages, clinical evidence is scarce. The only notable study, by Hamid, was limited by methodological shortcomings, including a short four-week observation period and a lack of long-term data. Importantly, no clinical trial has systematically evaluated sliding mechanics using a 0.020-inch round archwire, leaving a critical gap in the literature.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Canine retraction on a round cross-section archwire | Experimental | Procedure: Round-cross-section archwireThe patients in this group will be treated by sliding on a round cross-section archwire of 0.020-inch diameter. |
| Traditional canine retraction on a rectangular-cross-section archwire | Active comparator | Procedure: Rectangular-cross-section archwireThe patients in this group will be treated using a sliding rectangular arch wire with a diameter of 0.019 × 0.025 inches. |
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
- Mild to moderate skeletal Class II malocclusion (ANB angle between 5° and 7°),
- A normal to slightly increased vertical growth pattern (Björk's sum > 390° and < 406°),
- An overjet of 5-10 mm.
- A further prerequisite was a camouflage treatment plan involving the extraction of the maxillary first premolars.
Key exclusion criteria (5 listed)
- the presence of no systemic health issues or any systemic condition known to influence the rate of orthodontic tooth movement,
- active periodontal disease,
- absence of any permanent teeth in the upper arch (excluding third molars),
- crowding of 4 mm or greater,
- inadequate oral hygiene.
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 |
|---|---|---|
| Round-cross-section archwireCanines will be retracted on an archwire with a diameter of 0.20 inches. | Procedure or surgery | Canine retraction on a round cross-section archwire |
| Rectangular-cross-section archwireCanines will be retracted on an archwire with a diameter of 0.019 x 0.025-inch. | Procedure or surgery | Traditional canine retraction on a rectangular-cross-section archwire |
Primary outcome
Change in the Rate of Maxillary Canine Retraction
Time frame: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Canine displacement is measured by projecting the canine apex and the medial end of the third palatal ruga onto the mid-palatal plane; the linear distance between these points is recorded at each time point. Monthly retraction rates are calculated by dividing the change in displacement by the corresponding interval in months. For each subject, mean monthly rates for right and left canines are determined, and the cohort retraction rate is expressed as the average across all patients.
4 secondary outcomes
Change in Canine Rotation
Time frame: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Change in Anchorage Loss
Time frame: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Change in Canine Angulation
Time frame: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 months)
Root Resorption of the Canine
Time frame: T0: T0: 10 minutes before starting canine retraction stage; TF: At completion of canine retraction (expected to happen within 3 - 5 months)
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 Nov 2025.
- Background: PubMed 18678758Mavreas D, Athanasiou AE. Factors affecting the duration of orthodontic treatment: a systematic review. Eur J Orthod. 2008 Aug;30(4):386-95. doi: 10.1093/ejo/cjn018.
- Background: PubMed 36578856Al-Ibrahim HM, Hajeer MY, Burhan AS, Sultan K, Ajaj MA, Mahaini L. The Efficacy of Accelerating Orthodontic Tooth Movement by Combining Self-Ligating Brackets With One or More Acceleration Methods: A Systematic Review. Cureus. 2022 Dec 23;14(12):e32879. doi: 10.7759/cureus.32879. eCollection 2022 Dec.
- Background: PubMed 10327744Kusy RP, Whitley JQ. Influence of archwire and bracket dimensions on sliding mechanics: derivations and determinations of the critical contact angles for binding. Eur J Orthod. 1999 Apr;21(2):199-208. doi: 10.1093/ejo/21.2.199.
- Background: PubMed 17346599Southard TE, Marshall SD, Grosland NM. Friction does not increase anchorage loading. Am J Orthod Dentofacial Orthop. 2007 Mar;131(3):412-4. doi: 10.1016/j.ajodo.2006.09.037.
- Background: PubMed 2773871Tidy DC. Frictional forces in fixed appliances. Am J Orthod Dentofacial Orthop. 1989 Sep;96(3):249-54. doi: 10.1016/0889-5406(89)90462-9.
- Derived from this study: PubMed 42240945Kheshfeh MN, Hajeer MY, Alam MK, Al Hinnawi MF, Abou Hamed H. Evaluation of the efficacy of sliding mechanisms on round versus rectangular archwires in canine retraction after first premolar extraction in class II malocclusion: a randomized clinical trial. Prog Orthod. 2026 Jun 4;27(1):24. doi: 10.1186/s40510-026-00629-y.
- 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 N. Kheshfeh, DDS, MSc principal investigator
Department of Orthodontics, University of Damascus
Mohammad Younis Hajeer, DDS, MSc, PhD study chair
Department of Orthodontics, University of Damascus
Ahamd S. Burhan, DDS, MSc, PhD study director
Department of Orthodontics, Unviersity 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 Round-cross-section archwire and Rectangular-cross-section archwire 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 5 inclusion and 5 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 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 the Rate of Maxillary Canine Retraction (time frame: T0: 10 minutes before starting canine retraction stage; T1: 30 days following the onset of canine retraction; T2: 60 days; T3: 90 days following canine retraction onset; TF: At completion of canine retraction (expected to occur within 3-5 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 NCT07243509, 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 Nov 2025.