Malocclusion of Anterior TeethNCT07688655
Effects of Three Orthodontic Archwire Protocols on Root and Bone Changes
A study testing Square-shaped cross-sectional archwire, Rectangular-shaped cross-sectional archwire and Traditional sequence of archwires in people with Malocclusion of Anterior Teeth and Malocclusion; Displaced Teeth, run by Damascus University at 1 site in Syria.
Trial summary
This randomized controlled clinical trial compares the effects of three orthodontic archwire protocols used during the alignment phase on anterior tooth roots and the supporting alveolar bone. Participants were randomly allocated to one of three parallel groups according to the experimental archwire used. Read more about this study
- Who is it for?
- Ages 16 to 25 years
- Conditions the study is for
- Malocclusion of Anterior Teeth, Malocclusion; Displaced Teeth
- What is being tested?
- Square-shaped cross-sectional archwire, Rectangular-shaped cross-sectional archwire and Traditional sequence of archwires
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53 participants
- Where
- 1 siteSyria
- Study dates
- 3 Mar 2024to 25 Dec 2025
- 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 16 to 25 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients aged between 16 and 25 years
- Presence of a complete permanent dentition
- Moderate crowding ranging from 4 to 6 mm, according to Little's Irregularity Index (Little, 1975)
- Indication for non-extraction orthodontic treatment
- Normal or slightly retroclined incisors, as evaluated radiographically and on study models
- Good oral health status
- Periodontally healthy supporting tissues
Who cannot join
- Patients with severe skeletal discrepancies
- Patients with craniofacial anomalies
- Presence of impacted or supernumerary teeth
- History of previous orthodontic treatment
- Presence of systemic conditions or use of medications known to influence tooth movement
- Pregnant women
- Patients for whom the follow-up (T1) records were not obtained within the permitted 35-day window
Trial locations and contacts
1 site in 1 country.
Syria1 site
Department of Orthodontics, Faculty of Dentistry, University of Damascus
Damascus, Rif-dimashq Governorate, DM20AM19
About this study
Official title: Three-dimensional Evaluation of Volumetric Root Resorption and Alveolar Bone Changes Following Three Orthodontic Archwire Protocols: a Randomized Controlled Clinical Trial
This randomized controlled clinical trial compares the effects of three orthodontic archwire protocols used during the alignment phase on anterior tooth roots and the supporting alveolar bone. Participants were randomly allocated to one of three parallel groups according to the experimental archwire used. Cone-beam computed tomography (CBCT) images were obtained before treatment initiation and after completion of the follow-up period. The primary outcome is volumetric root resorption, while secondary outcomes include changes in Buccal alveolar bone height and thickness. Recruitment and follow-up have been completed, and the study is currently in the data verification and statistical analysis phase. The findings are expected to help clinicians choose archwire protocols that reduce undesirable biological side effects during orthodontic treatment.
Read the detailed description
Orthodontic tooth movement may result in undesirable biological side effects, including external root resorption and remodeling of the alveolar bone surrounding the moved teeth. These effects are clinically important because they may influence long-term tooth support and treatment safety. During the alignment phase of orthodontic treatment, different archwire designs may produce different biomechanical effects; however, evidence comparing their influence on root structure and alveolar bone remains limited.
This study is a randomized controlled clinical trial designed to compare three orthodontic archwire protocols during the alignment phase in patients undergoing fixed orthodontic treatment. The primary objective is to assess volumetric root resorption in the anterior teeth using three-dimensional CBCT-based measurements. Secondary objectives include assessment of alveolar bone height change, and alveolar bone thickness change at standardized cervical, middle, and apical levels.
Participants were enrolled from the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible patients were randomly allocated to one of three parallel groups. All groups received the same initial alignment sequence using 0.014-inch nickel-titanium and 0.016-inch nickel-titanium archwires. The groups differed in the experimental archwire used thereafter. The square group received a 0.016 × 0.016-inch nickel-titanium archwire, the rectangular group received a 0.016 × 0.022-inch nickel-titanium archwire, and the control group continued with a 0.016-inch round nickel-titanium archwire. Archwire changes were performed at standardized 35-day intervals according to the study protocol.
CBCT records were obtained at baseline before treatment initiation and again at the end of the observation period. Root volume measurements were used to calculate volumetric root resorption in cubic millimeters and as a percentage of the baseline root volume. Buccal alveolar bone height and thickness were measured on standardized CBCT sections using predefined reference planes and anatomical landmarks.
Participant recruitment started on 01 October 2023, and follow-up of the last participant was completed on 25 June 2025. The study is currently in the data verification and statistical analysis phase.
- Being tested
- Square-shaped cross-sectional archwire, Rectangular-shaped cross-sectional archwire, Traditional sequence of archwires
- Keywords
- Archwire sequence protocol, Volumetric external root resorption, Alveolar bone changes, Buccal alveolar bone height, Buccal alveolar bone thickness, Cone-beam computed tomography
- Medical subject headings
- Malocclusion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Square-shaped cross-sectional archwireProcedure or surgery
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.016-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Rectangular-shaped cross-sectional archwireProcedure or surgery
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.022-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals.
Traditional sequence of archwiresProcedure or surgery
Fixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016-inch round NiTi, which served as the control archwire. Archwire change will be done at 35-day intervals.
| Study group | Role | What they receive |
|---|---|---|
| Square-shaped cross-sectional archwire group | Experimental | Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.016-inch nickel-titanium archwire as the experimental archwire Receives: Procedure: Square-shaped cross-sectional archwire |
| Rectangular-shaped cross-sectional archwire group | Experimental | Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.022-inch nickel-titanium archwire as the experimental archwire Receives: Procedure: Rectangular-shaped cross-sectional archwire |
| Control group | Active comparator | Participants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016-inch round nickel-titanium archwire, which served as the control wire. Receives: Procedure: Traditional sequence of archwires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Volumetric External Root Resorption (VERR)
Volumetric root resorption was assessed in the anterior teeth using cone-beam computed tomography (CBCT) and three-dimensional volumetric analysis. Root volume was measured at baseline and follow-up, and the difference between the two measurements was recorded as volumetric root resorption. The unit of measurement was cubic millimeters (mm³).
Measured: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Secondary outcomes (4)
Buccal Alveolar Bone Height Change (DBH)
Buccal alveolar bone height was measured as the vertical distance from a standardized horizontal reference plane to the most coronal point of the Buccal alveolar crest on CBCT images. The change between baseline and follow-up was recorded in millimeters (mm).
Measured: Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Cervical Level (DBT-CT)
Buccal alveolar bone thickness at the cervical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Middle Level (DBT-MT)
Buccal alveolar bone thickness at the middle root level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Apical Level (DBT-AT)
Buccal alveolar bone thickness at the apical level was measured on CBCT images using a standardized geometric protocol. The change between baseline and follow-up was recorded in millimeters (mm).
Measured: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jul 2026
- Study start3 Mar 2024
- Primary completion16 Jun 2025
- Study completion25 Dec 2025
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 of Anterior TeethStudies 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
- 53 participants (actual)
Sponsor and investigators
- Lead sponsor
- Damascus University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Waseem M Allouch, DDS, MSc, Principal investigator, Faculty of Dentistry, University of Damascus.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07688655
- Sponsor's protocol ID
- UDDS-2026-Ortho-5
- Status last verified
- Jul 2026
- First submitted
- 15 Jun 2026
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Smale I, Artun J, Behbehani F, Doppel D, van't Hof M, Kuijpers-Jagtman AM. Apical root resorption 6 months after initiation of fixed orthodontic appliance therapy. Am J Orthod Dentofacial Orthop. 2005 Jul;128(1):57-67. doi: 10.1016/j.ajodo.2003.12.030.
PubMed 16027626Papageorgiou SN, Sifakakis I, Doulis I, Eliades T, Bourauel C. Torque efficiency of square and rectangular archwires into 0.018 and 0.022 in. conventional brackets. Prog Orthod. 2016;17:5. doi: 10.1186/s40510-016-0118-0. Epub 2016 Jan 15.
PubMed 26780465Montasser MA, Keilig L, Bourauel C. Archwire diameter effect on tooth alignment with different bracket-archwire combinations. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):76-83. doi: 10.1016/j.ajodo.2015.06.026.
PubMed 26718381Liu C, Wei Z, Jian F, McIntyre G, Millett DT, Lai W, Wang Y. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2024 Feb 6;2(2):CD007859. doi: 10.1002/14651858.CD007859.pub5.
PubMed 38319008Gravina MA, Brunharo IH, Fraga MR, Artese F, Campos MJ, Vitral RW, Quintao CC. Clinical evaluation of dental alignment and leveling with three different types of orthodontic wires. Dental Press J Orthod. 2013 Nov-Dec;18(6):31-7. doi: 10.1590/s2176-94512013000600006.
PubMed 24351147Ajmera S, Shivanand Venkatesh, Ganeshkar SV. Volumetric evaluation of root resorption during orthodontic treatment. J Clin Orthod. 2014 Feb;48(2):113-9. No abstract available.
PubMed 24763679
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Three-dimensional Evaluation of Volumetric Root Resorption and Alveolar Bone Changes Following Three Orthodontic Archwire Protocols: a Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07688655
- Acronym / sponsor ID
- UDDS-2026-Ortho-5
- Keywords
- Archwire sequence protocol, Volumetric external root resorption, Alveolar bone changes, Buccal alveolar bone height, Buccal alveolar bone thickness, Cone-beam computed tomography
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 53 participants (actual)
- Lead sponsor
- Damascus UniversityUniversity, hospital or other
- Study start
- 3 Mar 2024 (actual)
- Primary completion
- 16 Jun 2025 (actual)
- Study completion
- 25 Dec 2025 (actual)
- First posted
- 7 Jul 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 randomized controlled clinical trial compares the effects of three orthodontic archwire protocols used during the alignment phase on anterior tooth roots and the supporting alveolar bone. Participants were randomly allocated to one of three parallel groups according to the experimental archwire used. Cone-beam computed tomography (CBCT) images were obtained before treatment initiation and after completion of the follow-up period. The primary outcome is volumetric root resorption, while secondary outcomes include changes in Buccal alveolar bone height and thickness. Recruitment and follow-up have been completed, and the study is currently in the data verification and statistical analysis phase. The findings are expected to help clinicians choose archwire protocols that reduce undesirable biological side effects during orthodontic treatment.
Detailed description
Orthodontic tooth movement may result in undesirable biological side effects, including external root resorption and remodeling of the alveolar bone surrounding the moved teeth. These effects are clinically important because they may influence long-term tooth support and treatment safety. During the alignment phase of orthodontic treatment, different archwire designs may produce different biomechanical effects; however, evidence comparing their influence on root structure and alveolar bone remains limited.
This study is a randomized controlled clinical trial designed to compare three orthodontic archwire protocols during the alignment phase in patients undergoing fixed orthodontic treatment. The primary objective is to assess volumetric root resorption in the anterior teeth using three-dimensional CBCT-based measurements. Secondary objectives include assessment of alveolar bone height change, and alveolar bone thickness change at standardized cervical, middle, and apical levels.
Participants were enrolled from the Department of Orthodontics, Faculty of Dentistry, Damascus University. Eligible patients were randomly allocated to one of three parallel groups. All groups received the same initial alignment sequence using 0.014-inch nickel-titanium and 0.016-inch nickel-titanium archwires. The groups differed in the experimental archwire used thereafter. The square group received a 0.016 × 0.016-inch nickel-titanium archwire, the rectangular group received a 0.016 × 0.022-inch nickel-titanium archwire, and the control group continued with a 0.016-inch round nickel-titanium archwire. Archwire changes were performed at standardized 35-day intervals according to the study protocol.
CBCT records were obtained at baseline before treatment initiation and again at the end of the observation period. Root volume measurements were used to calculate volumetric root resorption in cubic millimeters and as a percentage of the baseline root volume. Buccal alveolar bone height and thickness were measured on standardized CBCT sections using predefined reference planes and anatomical landmarks.
Participant recruitment started on 01 October 2023, and follow-up of the last participant was completed on 25 June 2025. The study is currently in the data verification and statistical analysis phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Square-shaped cross-sectional archwire group | Experimental | Procedure: Square-shaped cross-sectional archwireParticipants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.016-inch nickel-titanium archwire as the experimental archwire |
| Rectangular-shaped cross-sectional archwire group | Experimental | Procedure: Rectangular-shaped cross-sectional archwireParticipants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016 × 0.022-inch nickel-titanium archwire as the experimental archwire |
| Control group | Active comparator | Procedure: Traditional sequence of archwiresParticipants in this group received fixed orthodontic treatment with an alignment sequence ending with a 0.016-inch round nickel-titanium archwire, which served as the control wire. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (7 listed)
- Patients aged between 16 and 25 years
- Presence of a complete permanent dentition
- Moderate crowding ranging from 4 to 6 mm, according to Little's Irregularity Index (Little, 1975)
- Indication for non-extraction orthodontic treatment
- Normal or slightly retroclined incisors, as evaluated radiographically and on study models
Key exclusion criteria (7 listed)
- Patients with severe skeletal discrepancies
- Patients with craniofacial anomalies
- Presence of impacted or supernumerary teeth
- History of previous orthodontic treatment
- Presence of systemic conditions or use of medications known to influence 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 |
|---|---|---|
| Square-shaped cross-sectional archwireFixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.016-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals. | Procedure or surgery | Square-shaped cross-sectional archwire group |
| Rectangular-shaped cross-sectional archwireFixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016 × 0.022-inch NiTi as the experimental archwire. Archwire change will be done at 35-day intervals. | Procedure or surgery | Rectangular-shaped cross-sectional archwire group |
| Traditional sequence of archwiresFixed orthodontic treatment using the following archwire sequence: 0.014-inch NiTi, followed by 0.016-inch NiTi, followed by 0.016-inch round NiTi, which served as the control archwire. Archwire change will be done at 35-day intervals. | Procedure or surgery | Control group |
Primary outcome
Volumetric External Root Resorption (VERR)
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Volumetric root resorption was assessed in the anterior teeth using cone-beam computed tomography (CBCT) and three-dimensional volumetric analysis. Root volume was measured at baseline and follow-up, and the difference between the two measurements was recorded as volumetric root resorption. The unit of measurement was cubic millimeters (mm³).
4 secondary outcomes
Buccal Alveolar Bone Height Change (DBH)
Time frame: Measured on CBCT images obtained at baseline before treatment initiation and at the end of six-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Cervical Level (DBT-CT)
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Middle Level (DBT-MT)
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
Buccal Alveolar Bone Thickness Change at the Apical Level (DBT-AT)
Time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.
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 7 Jul 2026.
- Background: PubMed 16027626Smale I, Artun J, Behbehani F, Doppel D, van't Hof M, Kuijpers-Jagtman AM. Apical root resorption 6 months after initiation of fixed orthodontic appliance therapy. Am J Orthod Dentofacial Orthop. 2005 Jul;128(1):57-67. doi: 10.1016/j.ajodo.2003.12.030.
- Background: PubMed 26780465Papageorgiou SN, Sifakakis I, Doulis I, Eliades T, Bourauel C. Torque efficiency of square and rectangular archwires into 0.018 and 0.022 in. conventional brackets. Prog Orthod. 2016;17:5. doi: 10.1186/s40510-016-0118-0. Epub 2016 Jan 15.
- Background: PubMed 26718381Montasser MA, Keilig L, Bourauel C. Archwire diameter effect on tooth alignment with different bracket-archwire combinations. Am J Orthod Dentofacial Orthop. 2016 Jan;149(1):76-83. doi: 10.1016/j.ajodo.2015.06.026.
- Background: PubMed 38319008Liu C, Wei Z, Jian F, McIntyre G, Millett DT, Lai W, Wang Y. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2024 Feb 6;2(2):CD007859. doi: 10.1002/14651858.CD007859.pub5.
- Background: PubMed 24351147Gravina MA, Brunharo IH, Fraga MR, Artese F, Campos MJ, Vitral RW, Quintao CC. Clinical evaluation of dental alignment and leveling with three different types of orthodontic wires. Dental Press J Orthod. 2013 Nov-Dec;18(6):31-7. doi: 10.1590/s2176-94512013000600006.
- Background: PubMed 24763679Ajmera S, Shivanand Venkatesh, Ganeshkar SV. Volumetric evaluation of root resorption during orthodontic treatment. J Clin Orthod. 2014 Feb;48(2):113-9. No abstract available.
- 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.
Waseem M Allouch, DDS, MSc principal investigator
Faculty of Dentistry, University of Damascus.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Square-shaped cross-sectional archwire, Rectangular-shaped cross-sectional archwire and Traditional sequence of archwires in people with Malocclusion of Anterior Teeth and Malocclusion; Displaced Teeth, 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 7 inclusion and 7 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 7 Jul 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?
Volumetric External Root Resorption (VERR) (time frame: Measured on CBCT images obtained at baseline (before treatment initiation) and at the end of the 6-month follow-up period.). 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 NCT07688655, 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 7 Jul 2026.