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

Bimaxillary Protrusion Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04902456
• Other study ID #: FUE.REC (13)/7-2019
• Status: Active, not recruiting
• Phase: N/A
• Start date: December 29, 2020
• Est. completion date: January 29, 2022

Study information

• Verified date: June 2021
• Source: Future University in Egypt
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: January 29, 2022
• Est. primary completion date: January 29, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 24 Years

Eligibility

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

Related Conditions & MeSH terms

• Bimaxillary Protrusion

Intervention

Procedure:
• Power chain and Crimpable hook fro En-masse Retraction
Retraction will start on a 0.017x0.025" stainless steel wire using elastomeric chain ( for applied will be 212 g per side ) extending between the cripmable hooks and the miniscrew
• 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.

Locations

Country	Name	City	State
Egypt	Amr Attia	Cairo	Future University In Egypt

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	Anchorage loss	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 )	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Retraction Rate	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 )	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Molar Rotation	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 )	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Pain of Intervention	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.	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Anterior teeth extrusion/intrusion	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in mm )	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Anterior teeth torque	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )	from pre to post retraction/intervention ( an average of 6-8 months )
Secondary	Anterior teeth tip	The principle investigator will examine pre and post Cone Beam CT ( CBCT ) in Relation to lines and reference planes ( measured in degrees )	from pre to post retraction/intervention ( an average of 6-8 months )