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

Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04902430
• Other study ID #: FUE.REC (8)/6-2019
• Status: Completed
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: August 12, 2022

Study information

• Verified date: December 2022
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: August 12, 2022
• Est. primary completion date: July 18, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

Procedure:
• Power 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
• T- 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

Locations

Country	Name	City	State
Egypt	Future University in Egypt	New Cairo	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Future University in Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	From pre to post retraction (an average of 6 - 8 months)
Secondary	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)	From pre to post retraction (an average of 6 - 8 months)
Secondary	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)	From pre to post retraction (an average of 6 - 8 months)
Secondary	Pain of intervention	Each patient will fill a questionnaire regarding his treatment experience in a VAS scoring from 1-10	From pre to post retraction/intervention (an average of 6 - 8 months)
Secondary	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)	From pre to post retraction (an average of 6 - 8 months)