Aligning ArchwiresNCT05391542
Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires
A study testing aligning archwires in people with Aligning Archwires, run by University of Baghdad at 1 site in Iraq.
Trial summary
This study will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Aligning Archwires
- What is being tested?
- aligning archwires
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteIraq
- Study dates
- 28 Feb 2022to 15 Oct 2022
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
- Presence of all the mandibular permanent teeth, except the third molars.
- Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
- No history of trauma or root resorption in the mandibular incisors.
Who cannot join
- Previous orthodontic treatment.
- Less than 5 mm of mandibular incisors crowding (LII).
- Severe crowding which requires treatment by extraction of premolars in the mandibular arch.
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Prior experience of periodontal disease and loss of attachment.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires: A Randomized Clinical Trial
This study will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption.
Read the detailed description
This will be a prospective blinded non-stratified randomized clinical trial , parallel group trial with equal randomization (1:1 allocation ratio), different private clinics and general hospitals will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. The patients were asked to read the patient information sheet carefully at home and inform the investigator about their decision of participation at the subsequent appointment and to sign consent form sheet in case of agreement.
The patients will be treated using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying
All the participants will receive the same treatment. At the day of bonding, the first archwire will be placed for each group. Eight weeks later it will be replaced by the next size archwire for another eight weeks. Archwires will be tied to the bracket using elastomeric ligatures. Any debonding during treatment should be considered an emergency and re-bonded within 24 hours, otherwise the case will be dropout. A good alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be given visual analog scale to record their pain p during the first week after each archwire placement.
- Conditions
- Aligning Archwires
- Being tested
- aligning archwires
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
aligning archwiresOther
At the day of bonding, 0.016-inch archwire will be placed for the TuNT group. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. While, for the CuNT group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules which will be changed every 4 weeks. A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement.
| Study group | Role | What they receive |
|---|---|---|
| Coaxial tubular superelastic nickel-titanium Group (TuNT) | Experimental | 0.016-inch coaxial tubular superelastic nickel-titanium archwire (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks Receives: Other: aligning archwires |
| Copper-nickel-titanium Group (CuNT) | Experimental | 0.014-inch Copper-nickel-titanium archwire (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Receives: Other: aligning archwires |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in alignment of anterior teeth will be measured using Little's irregularity index
A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index.
Measured: 16 weeks
Secondary outcomes (2)
Root resorption using the scoring index that was provided by Malmgren et al. (1982)
Root resorption will be evaluated for the mandibular central incisors using periapical radiographs with digital sensors, and the worst score for either left or right central will be taken using the scoring index by Malmgren et al. (1982):
- Grade 1: Irregular apical root contour.
- Grade 2: Minor apical root resorption, a small area of root loss amounting to less than 2 mm.
- Grade 3: Severe apical root resorption from 2 mm to one third of the original root length.
- Grade 4: Extreme apical root resorption exceeding one third of the original root length.
Measured: 16 weeks
pain perception using visual analog scale
Evaluations of pain/discomfort will be made in the evening on a daily basis over the first seven days after bonding using a 10-point visual analog scale (VAS) with 0 refers to "no pain" and 10 refers to "intolerable pain". The participants will be reminded daily by a phone call or a text message to mark the recording sheet and will be asked to bring it on their next appointment.
Measured: 1st week after each wire placement.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 May 2022
- Study start28 Feb 2022
- Primary completion15 Oct 2022
- Study completion15 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Aligning ArchwiresStudies of the same condition, open and under way.
- More trials run by University of BaghdadThe sponsor's other registered studies.
- 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
- Model description
- The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying Archwire sequence for each group will be as follows: 1. Coaxial tubular superelastic nickel-titanium Group (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada): * 0.016-inch * 0.018-inch 2. Copper-nickel-titanium Group (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif): * 0.014-inch * 0.018-inch Allocation Concealment: This will be achieved using sequentially numbered, opaque and sealed envelopes which will be numbered according to the study numbers. Each envelope includes the treatment allocation card (group 1 or 2) and the related archwires.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Baghdad
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reyam Mohammed Noori, University of Baghdad
- Investigators
- Yassir A. Yassir, M.Sc., P.hd. (UK), Study director, University of Baghdad
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05391542
- Sponsor's protocol ID
- 599422
- Status last verified
- May 2023
- First submitted
- 16 May 2022
- Last updated
- 11 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Atik E, Gorucu-Coskuner H, Akarsu-Guven B, Taner T. A comparative assessment of clinical efficiency between premium heat-activated copper nickel-titanium and superelastic nickel-titanium archwires during initial orthodontic alignment in adolescents: a randomized clinical trial. Prog Orthod. 2019 Dec 16;20(1):46. doi: 10.1186/s40510-019-0299-4.
PubMed 31840204Azizi F, Extiari A, Imani MM. Tooth alignment and pain experience with A-NiTi versus Cu-NiTi: a randomized clinical trial. BMC Oral Health. 2021 Sep 6;21(1):431. doi: 10.1186/s12903-021-01789-5.
PubMed 34488744Berger J, Waram T. Force levels of nickel titanium initial archwires. J Clin Orthod. 2007 May;41(5):286-92. No abstract available.
PubMed 17652862Fleming PS, Johal A. Self-ligating brackets in orthodontics. A systematic review. Angle Orthod. 2010 May;80(3):575-84. doi: 10.2319/081009-454.1.
PubMed 20050755Gil FJ, Planell JA. Effect of copper addition on the superelastic behavior of Ni-Ti shape memory alloys for orthodontic applications. J Biomed Mater Res. 1999;48(5):682-8. doi: 10.1002/(sici)1097-4636(1999)48:53.0.co;2-m.
PubMed 10490682Jian F, Lai W, Furness S, McIntyre GT, Millett DT, Hickman J, Wang Y. Initial arch wires for tooth alignment during orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD007859. doi: 10.1002/14651858.CD007859.pub3.
PubMed 23633347Kapila S, Sachdeva R. Mechanical properties and clinical applications of orthodontic wires. Am J Orthod Dentofacial Orthop. 1989 Aug;96(2):100-9. doi: 10.1016/0889-5406(89)90251-5.
PubMed 2667330Mahmoudzadeh M, Farhadian M, Alijani S, Azizi F. Clinical comparison of two initial arch wires (A-NiTi and Heat Activated NiTi) for amount of tooth alignment and perception of pain: A randomized clinical trial. Int Orthod. 2018 Mar;16(1):60-72. doi: 10.1016/j.ortho.2018.01.007. Epub 2018 Feb 23.
PubMed 29478933Montasser 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 26718381Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.
PubMed 32011678Papageorgiou SN, Konstantinidis I, Papadopoulou K, Jager A, Bourauel C. A systematic review and meta-analysis of experimental clinical evidence on initial aligning archwires and archwire sequences. Orthod Craniofac Res. 2014 Nov;17(4):197-215. doi: 10.1111/ocr.12048. Epub 2014 May 29.
PubMed 24889143Rucker BK, Kusy RP. Theoretical investigation of elastic flexural properties for multistranded orthodontic archwires. J Biomed Mater Res. 2002 Dec 5;62(3):338-49. doi: 10.1002/jbm.10325.
PubMed 12209919Sebastian B. Alignment efficiency of superelastic coaxial nickel-titanium vs superelastic single-stranded nickel-titanium in relieving mandibular anterior crowding: a randomized controlled prospective study. Angle Orthod. 2012 Jul;82(4):703-8. doi: 10.2319/072111-460.1. Epub 2011 Oct 19.
PubMed 22011096Wang Y, Liu C, Jian F, McIntyre GT, Millett DT, Hickman J, Lai W. Initial arch wires used in orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2018 Jul 31;7(7):CD007859. doi: 10.1002/14651858.CD007859.pub4.
PubMed 30064155Malmgren O, Goldson L, Hill C, Orwin A, Petrini L, Lundberg M. Root resorption after orthodontic treatment of traumatized teeth. Am J Orthod. 1982 Dec;82(6):487-91. doi: 10.1016/0002-9416(82)90317-7.
PubMed 6961819
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05391542
- Acronym / sponsor ID
- 599422
- Conditions
- Aligning Archwires
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- University of BaghdadUniversity, hospital or other
- Study start
- 28 Feb 2022 (actual)
- Primary completion
- 15 Oct 2022 (actual)
- Study completion
- 15 Oct 2022 (actual)
- First posted
- 26 May 2022 (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 will be done to compare the effectiveness of using coaxial tubular superelastic nickel-titanium and copper-nickel-titanium archwires during the initial phase of orthodontic treatment regarding alignment efficiency, pain perception, and root resorption.
Detailed description
This will be a prospective blinded non-stratified randomized clinical trial , parallel group trial with equal randomization (1:1 allocation ratio), different private clinics and general hospitals will allocate patients for this trial. The patients will be initially assessed for eligibility to be included in the study by the investigator. Those who will meet the inclusion criteria will be informed about the nature of the study verbally to take the initial approval for participation. The patients were asked to read the patient information sheet carefully at home and inform the investigator about their decision of participation at the subsequent appointment and to sign consent form sheet in case of agreement.
The patients will be treated using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying
All the participants will receive the same treatment. At the day of bonding, the first archwire will be placed for each group. Eight weeks later it will be replaced by the next size archwire for another eight weeks. Archwires will be tied to the bracket using elastomeric ligatures. Any debonding during treatment should be considered an emergency and re-bonded within 24 hours, otherwise the case will be dropout. A good alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be given visual analog scale to record their pain p during the first week after each archwire placement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- The patients will be treated with straight wire appliance using MBT prescription brackets with 0.022-inch slot (Pinnacle®, Ortho Technology, USA). Initially, teeth polishing will be performed with pumice and rubber cup, followed by water rinsing and air drying Archwire sequence for each group will be as follows: 1. Coaxial tubular superelastic nickel-titanium Group (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada): * 0.016-inch * 0.018-inch 2. Copper-nickel-titanium Group (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif): * 0.014-inch * 0.018-inch Allocation Concealment: This will be achieved using sequentially numbered, opaque and sealed envelopes which will be numbered according to the study numbers. Each envelope includes the treatment allocation card (group 1 or 2) and the related archwires.
| Arm | Type | Receives |
|---|---|---|
| Coaxial tubular superelastic nickel-titanium Group (TuNT) | Experimental | Other: aligning archwires0.016-inch coaxial tubular superelastic nickel-titanium archwire (TuNT) (Speed tubular supercable, Speed System™ Orthodontics, Ontario, Canada) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks |
| Copper-nickel-titanium Group (CuNT) | Experimental | Other: aligning archwires0.014-inch Copper-nickel-titanium archwire (CuNT) (Damon Optimal-Force Copper Ni-Ti®, Ormco, Glendora, Calif) will be placed in mandibular arch at the day of bonding. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Patients indicated for fixed appliance orthodontic treatment with 5-9 mm crowding of mandibular anterior teeth according to Little's irregularity index (LII).
- Presence of all the mandibular permanent teeth, except the third molars.
- Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
- No history of trauma or root resorption in the mandibular incisors.
Key exclusion criteria (5 listed)
- Previous orthodontic treatment.
- Less than 5 mm of mandibular incisors crowding (LII).
- Severe crowding which requires treatment by extraction of premolars in the mandibular arch.
- Blocked-out teeth that cannot be engaged with the aligning archwire.
- Prior experience of periodontal disease and loss of attachment.
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 |
|---|---|---|
| aligning archwiresAt the day of bonding, 0.016-inch archwire will be placed for the TuNT group. Eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. While, for the CuNT group, 0.014-inch archwire will be placed at the day of bonding and eight weeks later it will be replaced by the 0.018-inch archwire for another eight weeks. Archwires will be tied to the bracket by elastomeric modules which will be changed every 4 weeks. A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. Periapical X-ray for the mandibular central incisors will be taken pre-treatment and after 16 weeks. The participants will be provided by a visual analog scale (0-10) to record their pain perception during the first week after each wire placement. | Other | Coaxial tubular superelastic nickel-titanium Group (TuNT), Copper-nickel-titanium Group (CuNT) |
Primary outcome
Changes in alignment of anterior teeth will be measured using Little's irregularity index
Time frame: 16 weeks
A good-quality alginate impression for the lower arch should be taken pre-treatment and after 4, 8, 12 and 16 weeks and a stone study model is obtained. This study model which should be free from any discrepancy (such as bubbles) will be used to measure Little's irregularity index using a digital Vernier caliper to calculate the amount of mesial and distal contact displacement from the mesial contact surface of right mandibular canine to that on the other side, to the nearest 0.01 mm. The sum of these measurements represents the amount of Little's irregularity index.
2 secondary outcomes
Root resorption using the scoring index that was provided by Malmgren et al. (1982)
Time frame: 16 weeks
pain perception using visual analog scale
Time frame: 1st week after each wire placement.
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 11 May 2023.
- Background: PubMed 31840204Atik E, Gorucu-Coskuner H, Akarsu-Guven B, Taner T. A comparative assessment of clinical efficiency between premium heat-activated copper nickel-titanium and superelastic nickel-titanium archwires during initial orthodontic alignment in adolescents: a randomized clinical trial. Prog Orthod. 2019 Dec 16;20(1):46. doi: 10.1186/s40510-019-0299-4.
- Background: PubMed 34488744Azizi F, Extiari A, Imani MM. Tooth alignment and pain experience with A-NiTi versus Cu-NiTi: a randomized clinical trial. BMC Oral Health. 2021 Sep 6;21(1):431. doi: 10.1186/s12903-021-01789-5.
- Background: PubMed 17652862Berger J, Waram T. Force levels of nickel titanium initial archwires. J Clin Orthod. 2007 May;41(5):286-92. No abstract available.
- Background: PubMed 20050755Fleming PS, Johal A. Self-ligating brackets in orthodontics. A systematic review. Angle Orthod. 2010 May;80(3):575-84. doi: 10.2319/081009-454.1.
- Background: PubMed 10490682Gil FJ, Planell JA. Effect of copper addition on the superelastic behavior of Ni-Ti shape memory alloys for orthodontic applications. J Biomed Mater Res. 1999;48(5):682-8. doi: 10.1002/(sici)1097-4636(1999)48:53.0.co;2-m.
- Background: PubMed 23633347Jian F, Lai W, Furness S, McIntyre GT, Millett DT, Hickman J, Wang Y. Initial arch wires for tooth alignment during orthodontic treatment with fixed appliances. Cochrane Database Syst Rev. 2013 Apr 30;2013(4):CD007859. doi: 10.1002/14651858.CD007859.pub3.
- Background: PubMed 2667330Kapila S, Sachdeva R. Mechanical properties and clinical applications of orthodontic wires. Am J Orthod Dentofacial Orthop. 1989 Aug;96(2):100-9. doi: 10.1016/0889-5406(89)90251-5.
- Background: PubMed 29478933Mahmoudzadeh M, Farhadian M, Alijani S, Azizi F. Clinical comparison of two initial arch wires (A-NiTi and Heat Activated NiTi) for amount of tooth alignment and perception of pain: A randomized clinical trial. Int Orthod. 2018 Mar;16(1):60-72. doi: 10.1016/j.ortho.2018.01.007. Epub 2018 Feb 23.
- 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 32011678Nabbat SA, Yassir YA. A clinical comparison of the effectiveness of two types of orthodontic aligning archwire materials: a multicentre randomized clinical trial. Eur J Orthod. 2020 Dec 2;42(6):626-634. doi: 10.1093/ejo/cjz102.
- Background: PubMed 24889143Papageorgiou SN, Konstantinidis I, Papadopoulou K, Jager A, Bourauel C. A systematic review and meta-analysis of experimental clinical evidence on initial aligning archwires and archwire sequences. Orthod Craniofac Res. 2014 Nov;17(4):197-215. doi: 10.1111/ocr.12048. Epub 2014 May 29.
- Background: PubMed 12209919Rucker BK, Kusy RP. Theoretical investigation of elastic flexural properties for multistranded orthodontic archwires. J Biomed Mater Res. 2002 Dec 5;62(3):338-49. doi: 10.1002/jbm.10325.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yassir A. Yassir, M.Sc., P.hd. (UK) study director
University of Baghdad
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing aligning archwires in people with Aligning Archwires, run by University of Baghdad at 1 site in Iraq.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 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 11 May 2023. 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 Iraq. 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?
Changes in alignment of anterior teeth will be measured using Little's irregularity index (time frame: 16 weeks). 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 NCT05391542, which also lists 17 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 11 May 2023.