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CompletedNCT04902430Updated Dec 7, 2022

Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

An interventional study of Power chain and Crimpable hook for En-Masse Retraction and T- Loop in Bimaxillary Protrusion, sponsored by Future University in Egypt. Completed at 1 site in Egypt. Open to participants aged 14 Years to 24 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-12-07.

Sponsored by Future University in Egypt · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 4 months after the study started (first participant enrolled Dec 2020, registered May 2021).
Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
14 Years to 24 Years
Sex
All
01

Study summary

There's a scarcity in literature concerning en-masse retraction and its effect on the rate of tooth movement. The purpose of this study is to determine, In orthodontic patients with maxillary protrusion, which form of mechanics in en-masse retraction offers a faster rate of retraction; Friction or Frictionless Mechanics.

Read the detailed description

The en-masse technique can be done in one of two ways: through friction or frictionless mechanics. Both are viable options, but, ideally, we want to retract and complete the orthodontic treatment as quickly as possible, in order to decrease the negative effects that may occur during treatment. Which of these mechanics results in a decreased treatment time is still up for debate.

02

Conditions studied

  • Bimaxillary Protrusion

Keywords

  • En-masse Retraction
  • Friction
  • Fricitionless
  • Lateral Cephalometric
  • Rate
  • Dental Models
03

In context

Lead sponsor

Future University in Egypt is the lead sponsor of 97 studies on the registry; 26 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
14 Years to 24 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Adults and Adolescent patients (both genders)
  • Age range (14-24)
  • Patients with maxillary protrusion requiring first premolars extraction (Bimaxillary Protrusion or Class II division 1 cases).
  • Patients with fully erupted permanent teeth (not necessarily including the third molar).
  • Cases requiring maximum anchorage during retraction.
  • Good general and oral health

Exclusion criteria

Exclusion Criteria:

  • Patients suffering from any systemic diseases interfering with tooth movement.
  • Patients with extracted or missing permanent teeth. (except for third molars).
  • Patients with badly decayed teeth.
  • Patients with any parafunctional habits (i.e. Bruxism, tongue thrusting, mouth breathing, etc...).
  • Patients with previous orthodontic treatment
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    En-Masse Retraction using sliding mechanics (Friction)

    6 anterior teeth (en-Masse) retracted using a crimpable hook distal to the upper lateral incisor and a power chain

    Procedure: Power chain and Crimpable hook for En-Masse Retraction

  • Experimental
    En-Masse Retraction using segmental mechanics (Frictionless)

    6 anterior teeth (en-Masse) retracted using a T- loop

    Procedure: T- Loop

Interventions

  • ProcedurePower chain and Crimpable hook for En-Masse Retraction

    Retraction will start on a 0.017"x0.025" Stainless steel wire using elastomeric chain (force applied will be 212 g per side) extending between the crimpable hooks and the miniscrew

  • ProcedureT- Loop

    Closing retraction T-loops will be fabricated using 0.017 x 0.025 TMA wire. The loop will be positioned halfway the extraction space and the canine

06

What researchers measure

Primary outcomes

  1. Retraction Rate

    The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitilized study models taken of the patients monthly (measured in mm)

    Time frame: From pre to post retraction (an average of 6 - 8 months)

Secondary outcomes

  1. Anchorage Loss

    Digitilized dental models taken before and after the completion of retraction will be measured by identifying landmarks and reference lines and planes (measured in mm)

    Time frame: From pre to post retraction (an average of 6 - 8 months)

  2. Molar Rotation

    Study models that are taken pre and post retraction (then digitilized) will be used to assess the rotation of the maxillary first molars in relation to a reference line (measurement of the angles in degrees)

    Time frame: From pre to post retraction (an average of 6 - 8 months)

  3. Pain of intervention

    Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10

    Time frame: From pre to post retraction/intervention (an average of 6 - 8 months)

  4. Anterior teeth torque, extrusion/intrusion

    The principle investigator will examine pre and post lateral cephalometric radiographs in relation to lines and reference planes (measurements in degrees and mm)

    Time frame: From pre to post retraction (an average of 6 - 8 months)

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Study locations

1 site
  • Future University in Egypt
    New Cairo, Cairo, Egypt
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Dec 1, 2019
  • Informed consent form · Dec 1, 2019

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Yes — All collected IPD

Supporting information: Study protocol, Sap, Icf

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 7, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04902430
Lead sponsor
Future University in Egypt
Responsible party
Leena Alaa Shibl (Principle Investigator, Future University in Egypt) — Principal investigator
First posted
May 26, 2021
Start date
Dec 29, 2020
Primary completion
Jul 18, 2022
Completion
Aug 12, 2022
Last update
Dec 7, 2022

Study contacts

Yehia Mostafa, Professor and Chairman
study director · Future University in Egypt

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.

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