Effectiveness of Tubular Coaxial Nickel-titanium and Copper Nickel-titanium Orthodontic Aligning Archwires
NCT ID: NCT05391542
Last Updated: 2023-05-11
Study Results
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Basic Information
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COMPLETED
NA
33 participants
INTERVENTIONAL
2022-02-28
2022-10-15
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
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.
TREATMENT
TRIPLE
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.
Blinding As the study will be conducted in different clinics, all data collection and measurement will be completed with the investigator being masked to the allocation groups, though blinding of the operator will not be possible during the archwire placement.
Study Groups
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Coaxial tubular superelastic nickel-titanium Group (TuNT)
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
aligning archwires
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.
Copper-nickel-titanium Group (CuNT)
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.
aligning archwires
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.
Interventions
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aligning archwires
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.
Eligibility Criteria
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Inclusion Criteria
2. Presence of all the mandibular permanent teeth, except the third molars.
3. Overbite and overjet that do not interfere with bracket placement on mandibular anterior teeth.
4. No history of trauma or root resorption in the mandibular incisors.
Exclusion Criteria
2. Less than 5 mm of mandibular incisors crowding (LII).
3. Severe crowding which requires treatment by extraction of premolars in the mandibular arch.
4. Blocked-out teeth that cannot be engaged with the aligning archwire.
5. Prior experience of periodontal disease and loss of attachment.
ALL
Yes
Sponsors
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University of Baghdad
OTHER
Responsible Party
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Reyam Mohammed Noori
Orthodontics master student
Principal Investigators
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Yassir A. Yassir, M.Sc., P.hd. (UK)
Role: STUDY_DIRECTOR
University of Baghdad
Locations
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Baghdad college of dentistry
Baghdad, , Iraq
Countries
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References
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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.
Azizi 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.
Berger J, Waram T. Force levels of nickel titanium initial archwires. J Clin Orthod. 2007 May;41(5):286-92. No abstract available.
Fleming 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.
Gil 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.
Jian 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.
Kapila 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.
Mahmoudzadeh 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.
Montasser 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.
Nabbat 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.
Papageorgiou 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.
Rucker 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.
Sebastian 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.
Wang 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.
Malmgren 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.
Noori RM, Ahmed OK, Kadhum AS, Yassir YA, Di Blasio M, Russo D, Cicciu M, Minervini G. The Effectiveness of Conventional and Advanced Aligning Archwires: The Insights of Two Randomized Clinical Trials. Eur J Dent. 2025 Apr 4. doi: 10.1055/s-0044-1795080. Online ahead of print.
Noori RM, Yassir YA. Effectiveness of tubular coaxial nickel-titanium and copper nickel-titanium orthodontic aligning archwires: A randomized clinical trial. Int Orthod. 2023 Dec;21(4):100812. doi: 10.1016/j.ortho.2023.100812. Epub 2023 Sep 28.
Provided Documents
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Document Type: Study Protocol, Statistical Analysis Plan, and Informed Consent Form
Other Identifiers
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599422
Identifier Type: -
Identifier Source: org_study_id
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