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Clinical Trials/NCT04902430
NCT04902430CompletedNot Applicable

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

Future University in Egypt1 site in 1 country30 target enrollmentStarted: December 29, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Retraction Rate

Study Overview

Brief 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.

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Single (Outcomes Assessor)

Masking Description

Only the outcome assessors will be blind. The patients name will be sealed from pre and post radiographs and study models. Then two assessors will carry out, blindly and independently, the measurements and analysis of the study

Eligibility Criteria

Ages
14 Years to 24 Years (Child, Adult)
Sex
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

  • •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

Arms & Interventions

En-Masse Retraction using sliding mechanics (Friction)

Experimental

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

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

En-Masse Retraction using segmental mechanics (Frictionless)

Experimental

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

Intervention: T- Loop (Procedure)

Outcomes

Primary Outcomes

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

  • Pain of intervention(From pre to post retraction/intervention (an average of 6 - 8 months))
  • Anchorage Loss(From pre to post retraction (an average of 6 - 8 months))
  • Molar Rotation(From pre to post retraction (an average of 6 - 8 months))
  • Anterior teeth torque, extrusion/intrusion(From pre to post retraction (an average of 6 - 8 months))

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Leena Alaa Shibl

Principle Investigator

Future University in Egypt

Study Sites (1)

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