NCT03261024|UnknownDMC
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Sponsor study identifier
interventional
30
0 countries
N/A
Study Start
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
This study is a Randomized clinical trial comparing the effectiveness of two different mechanics during maxillary en-masse retraction in adult patients. Patients will be randomly divided into two groups:Friction and frictionless mechanics. Mini screws will be used in both group to ensure maximum anchorage during retraction. Lateral cephalometric radiographs and dental models will be taken for each patients pre and post -retraction. Following complete anterior segment retraction, the rate and duration of retraction will be evaluated for both groups as well as patient satisfaction with treatment. Changes in incisors inclination and soft tissue as well as anchorage loss will be also assessed.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
August 21, 2017
Actual (reported)August 24, 2017
Actual (reported)November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Duration of retraction
months through clinical examination of the retracted anterior teeth
After complete retraction, average 9 months
Rate of retraction
millimeters through dental models taken for each patient monthly at the follow up visit
Average 9 months, recorded from the begin of retraction till the complete retraction of anterior teeth
Patient Satisfaction
Questionnaire will be filled by every patient at the end of the study regarding his experience and acceptance to the treatment, scale from 0 to 5 .
After complete retraction , average 9 months
Change in incisors inclination
After complete retraction, average 9 months
Change in soft tissue profile
After complete retraction, average 9 months
molar anchorage loss
After complete retraction, average 9 months
Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires. Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally. Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. Hook between upper laterals and canines will be fixed on the main archwire. Nickel Titanium coil spring ( friction mechanics of retraction)will be used for maxillary en-masse retraction by extending the spring from the hook to the molar bands. Re-activation of the coil spring will be done in the follow up visits to maintain a constant force through the study.
Upper and lower arches will be bonded, leveled and aligned until reaching 0.019 x 0.025 st st archwires. Miniscrews will be inserted in the buccal alveolar bone between second premolars and first molars bilaterally. Miniscrews will be connected to the molar bands by rigid wire. Extraction of upper first premolars. Upper anterior teeth will be ligated together. T-loops retraction arch ( frictionless mechanics of retraction)will be used for maxillary en-masse retraction. The wire will be cinched distal to the molar bands. Re-activation of the retraction loops will be done in the follow up visits to maintain a constant force through the study
Nickel Titanium will be extended from the hook between the lateral incisors and canines to the first molar bands, to allow frictional en-masse retraction of anterior segment.
T-loops retraction arch will be placed distal to the upper canines and cinched distal to the first molar bands, to allow frictionless en-masse retraction of anterior segment.
Bills DA, Handelman CS, BeGole EA. Bimaxillary dentoalveolar protrusion: traits and orthodontic correction. Angle Orthod. 2005 May;75(3):333-9. doi: 10.1043/0003-3219(2005)75[333:BDPTAO]2.0.CO;2.
Park HS, Kwon TG. Sliding mechanics with microscrew implant anchorage. Angle Orthod. 2004 Oct;74(5):703-10. doi: 10.1043/0003-3219(2004)0742.0.CO;2.
Park HS, Yoon DY, Park CS, Jeoung SH. Treatment effects and anchorage potential of sliding mechanics with titanium screws compared with the Tweed-Merrifield technique. Am J Orthod Dentofacial Orthop. 2008 Apr;133(4):593-600. doi: 10.1016/j.ajodo.2006.02.041.
Fatma A. Abd El Sayed, Professor
Cairo University
Fady H. Fahim, lecturer
Cairo University
First Submitted
August 21, 2017
First Posted
August 24, 2017
Study Start
November 2017
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
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Upadhyay M, Yadav S, Patil S. Mini-implant anchorage for en-masse retraction of maxillary anterior teeth: a clinical cephalometric study. Am J Orthod Dentofacial Orthop. 2008 Dec;134(6):803-10. doi: 10.1016/j.ajodo.2006.10.025.
Heo W, Nahm DS, Baek SH. En masse retraction and two-step retraction of maxillary anterior teeth in adult Class I women. A comparison of anchorage loss. Angle Orthod. 2007 Nov;77(6):973-8. doi: 10.2319/111706-464.1.
Al-Sibaie S, Hajeer MY. Assessment of changes following en-masse retraction with mini-implants anchorage compared to two-step retraction with conventional anchorage in patients with class II division 1 malocclusion: a randomized controlled trial. Eur J Orthod. 2014 Jun;36(3):275-83. doi: 10.1093/ejo/cjt046. Epub 2013 Jun 20.
Felemban NH, Al-Sulaimani FF, Murshid ZA, Hassan AH. En masse retraction versus two-step retraction of anterior teeth in extraction treatment of bimaxillary protrusion. J Orthod Sci. 2013 Jan;2(1):28-37. doi: 10.4103/2278-0203.110330.
Ribeiro GL, Jacob HB. Understanding the basis of space closure in Orthodontics for a more efficient orthodontic treatment. Dental Press J Orthod. 2016 Mar-Apr;21(2):115-25. doi: 10.1590/2177-6709.21.2.115-125.sar.
Jee JH, Ahn HW, Seo KW, Kim SH, Kook YA, Chung KR, Nelson G. En-masse retraction with a preformed nickel-titanium and stainless steel archwire assembly and temporary skeletal anchorage devices without posterior bonding. Korean J Orthod. 2014 Sep;44(5):236-45. doi: 10.4041/kjod.2014.44.5.236. Epub 2014 Sep 25.
Upadhyay M, Yadav S, Nagaraj K, Patil S. Treatment effects of mini-implants for en-masse retraction of anterior teeth in bialveolar dental protrusion patients: a randomized controlled trial. Am J Orthod Dentofacial Orthop. 2008 Jul;134(1):18-29.e1. doi: 10.1016/j.ajodo.2007.03.025.
Kulshrestha RS, Tandon R, Chandra P. Canine retraction: A systematic review of different methods used. J Orthod Sci. 2015 Jan-Mar;4(1):1-8. doi: 10.4103/2278-0203.149608.
Baxmann M, McDonald F, Bourauel C, Jager A. Expectations, acceptance, and preferences regarding microimplant treatment in orthodontic patients: A randomized controlled trial. Am J Orthod Dentofacial Orthop. 2010 Sep;138(3):250.e1-250.e10; discussion 250-1. doi: 10.1016/j.ajodo.2010.03.023.
Lee J, Miyazawa K, Tabuchi M, Sato T, Kawaguchi M, Goto S. Effectiveness of en-masse retraction using midpalatal miniscrews and a modified transpalatal arch: Treatment duration and dentoskeletal changes. Korean J Orthod. 2014 Mar;44(2):88-95. doi: 10.4041/kjod.2014.44.2.88. Epub 2014 Mar 19.
Monga N, Kharbanda OP, Samrit V. Quantitative and qualitative assessment of anchorage loss during en-masse retraction with indirectly loaded miniscrews in patients with bimaxillary protrusion. Am J Orthod Dentofacial Orthop. 2016 Aug;150(2):274-82. doi: 10.1016/j.ajodo.2016.02.014.
Hedayati Z, Shomali M. Maxillary anterior en masse retraction using different antero-posterior position of mini screw: a 3D finite element study. Prog Orthod. 2016 Dec;17(1):31. doi: 10.1186/s40510-016-0143-z. Epub 2016 Oct 3.
Ziegler P, Ingervall B. A clinical study of maxillary canine retraction with a retraction spring and with sliding mechanics. Am J Orthod Dentofacial Orthop. 1989 Feb;95(2):99-106. doi: 10.1016/0889-5406(89)90388-0.
Viecilli RF. Self-corrective T-loop design for differential space closure. Am J Orthod Dentofacial Orthop. 2006 Jan;129(1):48-53. doi: 10.1016/j.ajodo.2004.05.025.
Lee D, Heo G, El-Bialy T, Carey JP, Major PW, Romanyk DL. Initial forces experienced by the anterior and posterior teeth during dental-anchored or skeletal-anchored en masse retraction in vitro. Angle Orthod. 2017 Jul;87(4):549-555. doi: 10.2319/080916-616.1. Epub 2016 Nov 10.
Rhee JN, Chun YS, Row J. A comparison between friction and frictionless mechanics with a new typodont simulation system. Am J Orthod Dentofacial Orthop. 2001 Mar;119(3):292-9. doi: 10.1067/mod.2001.112452.
Magdi S, Abdelsayed FA, Aboulfotouh MH, Fahim FH. Friction versus frictionless mechanics during maxillary en-masse retraction in adult patients with Class I bimaxillary dentoalveolar protrusion: a randomized clinical trial. Eur J Orthod. 2024 Aug 1;46(4):cjae034. doi: 10.1093/ejo/cjae034.
January 2019
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
January 2019
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
August 24, 2017
Record last verified: 2017-08
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