Viewing Study NCT05963438



Ignite Creation Date: 2024-05-06 @ 7:18 PM
Last Modification Date: 2024-10-26 @ 3:04 PM
Study NCT ID: NCT05963438
Status: COMPLETED
Last Update Posted: 2024-02-28
First Post: 2023-07-19

Brief Title: Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage
Sponsor: Dow University of Health Sciences
Organization: Dow University of Health Sciences

Study Overview

Official Title: Comparison Of En-Masse Retraction With Two-Step Retraction Using Mini-Implant As Anchorage - A Randomized Controlled Trial
Status: COMPLETED
Status Verified Date: 2024-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal vertical and dental dimensions using mini-implant as anchorage
Detailed Description: Extractions of teeth are the commonest approach in treating orthodontic problems There is several extraction protocol commonly employed in the orthodontic correction of class II malocclusion ranging from the extraction of two premolars 202 to four premolars 429

Retraction of anterior teeth followed by the extraction of premolars requires anchorage to restrict the mesial movement of posterior teeth Anchorage control is a major factor in achieving successful orthodontic treatment and it can be achieved by variety of appliances of which titanium screws have been considered as an absolute source of anchorage in orthodontics treatment The anchorage reinforced from mini-implant is helpful in minimizing anchorage loss and accepted heavy traction forces

Retraction of anterior teeth can be achieved either by en-masse retraction moving all the six anterior teeth together in a single step or by two-step retraction separately retract canines in first step followed by retracting the four anteriors in the second step

This Randomized Control Trial will be conducted to compare the effects of en-masse retraction to two- steps retraction on sagittal vertical and dental dimensions using mini-implant as anchorage 80 patients will be included in this study after meeting the eligibility criteria Each group will contain 40 patients

The patients will be divided in two groups ie two-step retraction group control group and en-masse group experimental group through software generated randomization table

Two-step retraction group control group In this group immediately after placement of mini-implant and extractions of upper first premolars heavy ligation will be done from mini-implant to maxillary second premolar and first molar Canine will be retracted by sliding mechanics and the four anterior teeth will be retracted by loop mechanics Loops will be activated every three weeks by 1 mm

Retraction will be stopped when canines establish class I relationship and a good incisor relationship will be obtained in both the groups

En-masse retraction groupexperimental group After placement of mini-implants and extraction of maxillary first premolar rectangular stainless steel arch wire with anterior 8mm height crimpable hooks distal to the lateral incisors will be inserted and force will be applied using elastic chains attached between the mini-implant and the hooks for conducting en-masse retraction Elastic chains will replace after every three weeks

Pretreatment lateral cepalogram will be taken at time of enrolment T1 and post-treatment lateral cephalogram taken after 12 months of orthodontic treatment T2 All cephalometric radiograph will be traced on acetate tracing sheets 05 μm in thickness using a sharp 4H pencil on a view box using transilluminated light in a dark room

The analysis will be done on pretreatment cephalogram T1 and post treatment lateral cephalogram T2 and then their measurements will be compared to find out changes in the sagittal vertical and dental dimensions

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None