Evaluation of the Anchorage Loss During En-masse Retraction in Orthodontic Patients With Maxillary Protrusion

Not Applicable

• Conditions: Bimaxillary Protrusion
• Interventions: Procedure: Power chain and Crimpable hook fro En-masse Retraction; Procedure: T-loop

• Registration Number: NCT04902456
• Lead Sponsor: Future University in Egypt

Brief Summary

There is scarcity in literature regarding the effectiveness of friction and frictionless mechanics during ''En-masse retraction''technique on anchorage loss of posterior segment in orthodontic patients with maxillary protrusion. Moreover there is deficiency in studies measuring the patient pain and satisfaction regarding the different techniques of retraction.

The aim of the current study is to evaluate the effects of friction versus frictionless mechanics, implemented during "En-masse retraction", on anchorage loss. Additionally, assessment of both techniques regarding their rates, effects on root resorption as well as patient satisfaction.

Detailed Description

One of the most common complaints of orthodontic patients is proclination of anterior teeth where there is an increase in facial convexity and as well as incompetent lips. Bimaxillary dentoalveolar protrusion and class II division I cases always have this appearance. Frequently this situation requires extraction of the first premolars followed by fixed orthodontic appliance for space closure and retraction of anterior teeth. Different techniques are used including "Two-step retraction" where canines are retracted as a first step followed by anterior four incisors as a second step and "En-masse retraction" where anterior teeth are retracted as one unit. However, the method of "En-masse retraction" is controversial - whether to use frictionless or friction mechanics.

Study Timeline

• Study Start: 2020-12-29
• Study First Submitted: 2021-05-15
• Study First Submitted QC: 2021-05-23
• Study First Posted: 2021-05-26
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-08
• Last Update Posted: 2021-06-11
• Primary Completion: 2022-01-29
• Study Completion: 2022-01-29

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Orthodontic patients (both genders)
2. Age range (14-24)
3. Patients requiring 1st premolars extraction followed by ''En-masse retraction'' (Bimaxillary Protrusion or Class II division 1 cases).
4. Patients with fully erupted permanent teeth (not necessarily including the 3rd molar).
5. Cases requiring maximum anchorage during anterior segment retraction.
6. Cases with minimal crowding (2-3) mm

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Power Chain and Crimpable hook for En-masse retraction	Power chain and Crimpable hook fro En-masse Retraction	Retraction will start on a 0.017x0.025" Stainless Steel wire using elastomeric chain ( force applied will be 212 g per side ) extending between the crimpable hooks and the miniscrew
T-loop	T-loop	Closing retraction T-loops will be fabricated using 0.017x0.025" TMA wire. The loop will be positioned halfway the extraction space and the canine.

Primary Outcome Measures

Name	Time	Method
Anchorage loss	from pre to post retraction/intervention ( an average of 6-8 months )	Digitally scanned dental models taken pre and post completion of retraction will be measured by identifying landmarks and reference lines and planes ( measured in mm )

Secondary Outcome Measures

Name	Time	Method
Retraction Rate	from pre to post retraction/intervention ( an average of 6-8 months )	The antero-posterior movement of anterior teeth and first molars will be assessed by measuring the digitally scanned dental models taken of the patients monthly ( measured in mm )
Pain of Intervention	from pre to post retraction/intervention ( an average of 6-8 months )	each patient will fill a questionnaire regarding his treatment experience in a Visual Analog Scale (VAS) scoring from 1-10 by making a handwritten mark on a 10-cm line that represents a continuum between "no pain" on the left end (0 cm) of the scale and the "worst pain" on the right end of the scale (10 cm). The question-naire will include several questions related to oral hygiene, pain and discomfort experienced throughout the trial.
Anterior teeth torque	from pre to post retraction/intervention ( an average of 6-8 months )	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )
Anterior teeth tip	from pre to post retraction/intervention ( an average of 6-8 months )	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )
Molar Rotation	from pre to post retraction/intervention ( an average of 6-8 months )	Digitally scanned dental models that are taken before and after retraction will be assess the rotation of the maxillary first permanent molar in relation to a reference line ( measurement of the angles in degrees )
Anterior teeth extrusion/intrusion	from pre to post retraction/intervention ( an average of 6-8 months )	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in mm )

Trial Locations

Locations (1)

Amr Attia; 🇪🇬 Cairo, Future University In Egypt, Egypt