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Completed

NCT Number: NCT04902430

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

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.

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Key information

Conditions

Bimaxillary Protrusion

Age range

14 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Future University in Egypt

New Cairo, Cairo Governorate, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Power chain and Crimpable hook for En-Masse Retraction

Procedure

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

T- Loop

Procedure

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

Primary outcomes

  1. Retraction Rate

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

    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)

Secondary outcomes

  1. Anchorage Loss

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

    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)

  2. Molar Rotation

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

    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)

  3. Pain of intervention

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

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

  4. Anterior teeth torque, extrusion/intrusion

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

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

Sponsors and collaborators

Lead sponsor

Future University in Egypt

Other

Registry information

Official study title

Evaluation of the Rate of En-masse Retraction in Orthodontic Patients With Maxillary Protrusion Using Friction Versus Frictionless Mechanics: A Randomized Clinical Trial

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
May 26, 2021
Registry last updated
Dec 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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