NCT03261024

Brief Summary

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2017

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 21, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 24, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

November 1, 2017

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

August 24, 2017

Status Verified

August 1, 2017

Enrollment Period

1.2 years

First QC Date

August 21, 2017

Last Update Submit

August 23, 2017

Conditions

En-masse Retraction , Class I Bimaxillary Protrusion

Keywords

En-masse retraction , Class I bimaxillary protrusion

Outcome Measures

Primary Outcomes (3)

  • 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

Secondary Outcomes (3)

  • 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

Study Arms (2)

Friction mechanics

ACTIVE COMPARATOR

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.

Device: Friction mechanics

Frictionless mechanics

ACTIVE COMPARATOR

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

Device: Frictionless mechanics

Interventions

Friction mechanicsDEVICE

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.

Also known as: Nickel Titanium coil spring
Friction mechanics
Frictionless mechanicsDEVICE

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.

Also known as: T-loops archwire
Frictionless mechanics

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Male or female adult patients with age range 18-30 yrs old.
  • Class I bimaxillary dentoalveolar protrusion .
  • Full permanent dentition.
  • Good oral hygiene.
  • Maximum anchorage is required.
  • Healthy bone between first molars and second premolars is needed.

You may not qualify if:

  • Systemic disease.
  • Severe crowding.
  • Extracted or missing upper permanent tooth/teeth (except for third molars).
  • Any signs or symptoms or previous history of temporomandibular disorders (TMD).
  • Previous orthodontic treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (20)

  • 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.

    PMID: 15898369BACKGROUND

  • 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.

    PMID: 15529508BACKGROUND

  • 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.

    PMID: 18405824BACKGROUND

  • 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.

    PMID: 19061808BACKGROUND

  • 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.

    PMID: 18004930BACKGROUND

  • 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.

    PMID: 23787192BACKGROUND

  • 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.

    PMID: 24987640BACKGROUND

  • 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.

    PMID: 27275623BACKGROUND

  • 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.

    PMID: 25309863BACKGROUND

  • 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.

    PMID: 18617099BACKGROUND

  • 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.

    PMID: 25657985BACKGROUND

  • 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.

    PMID: 20816284BACKGROUND

  • 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.

    PMID: 24696825BACKGROUND

  • 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.

    PMID: 27476360BACKGROUND

  • 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.

    PMID: 27667816BACKGROUND

  • 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.

    PMID: 2916474BACKGROUND

  • 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.

    PMID: 16443478BACKGROUND

  • 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.

    PMID: 27830931BACKGROUND

  • 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.

    PMID: 11244423RESULT

  • 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.

    PMID: 39011819DERIVED

Study Officials

  • Fatma A. Abd El Sayed, Professor

    Cairo University

    STUDY CHAIR

  • Fady H. Fahim, lecturer

    Cairo University

    STUDY DIRECTOR

Central Study Contacts

Fady H. Fahim, Lecturer

CONTACT

+20-01006882595fady.fahim@gmail.com

Fatma A. Abd El Sayed, Professor

CONTACT

+20-01005275779fatmaabdou65@yahoo.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer- Orthodontic department

Study Record Dates

First Submitted

August 21, 2017

First Posted

August 24, 2017

Study Start

November 1, 2017

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

August 24, 2017

Record last verified: 2017-08