Effects on Maxillary Anterior Dentition Following En Masse Retraction Using Mini-implants and Various Heights of Anterior Power Arm.

Effects On Maxillary Anterior Dentition Following En- Masse Retraction Using Mini-Implants and Various Heights of Anterior Power Arm- A Randomized Controlled Trial

The controlled three dimensional movement of anterior dentition during orthodontic treatment is a desire of every orthodontist. Maxillary en masse retraction with mini implants has been reported to provide absolute anchorage thus utilizing the complete extraction spaces thereby enhancing patient's esthetics. Power arm or anterior retraction hook permits the application of force close to a desired direction thereby warranting better anterior dentition control. Various heights of power arms and proposed centre of resistance for six maxillary anterior teeth have been estimated through finite element model and also from a very limited number of clinical studies. For a set of teeth, the determination of centre of resistance is complex in actual clinical scenario and response of force applied from certain level for better anterior dentition control requires sufficient clinical evidence suggestive of further clinical studies to endow orthodontists to hasten treatment due to less time consumption during finishing stage of orthodontic treatment.

Study Overview

• Status: Completed
• Conditions: Varying Heights of Power Arm During en Masse Retraction
• Intervention / Treatment: Other: Anterior Power Arm

Detailed Description

This Randomized Control Trial will be conducted to compare the effects of various heights of anterior power arm on maxillary anterior dentition following en masse retraction with mini-implants by participation of thirty patients meeting eligibility criteria. The participants will be divided in three groups through software generated randomization table. Group I (control group; height of anterior power arm 6 mm), Group II and Group III (experimental groups; height of anterior power arm 3 mm and 9 mm, respectively). Ten patients will be allocated in each group. En masse retraction with mini implants and various heights of anterior power arm will be carried out immediately after bilateral maxillary first premolar extractions using continuous arch sliding mechanics. Horizontal, vertical and angular dimensions will be measured on lateral cephalograms while the transverse effects will be measured on maxillary dental cast. Both lateral cephalograms and dental casts will be obtained at two different point of time; T1, before retraction and T2, after complete extraction space closure. The data will be assessed with-in and among groups.

• Study Type: Interventional
• Enrollment (Actual): 30
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan
      • Department of Orthodontics , DIEKIOHS, Dow University Of Health Sciences, Ojha Campus.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 30 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion criteria

• Patients between ages 18-30 years.
• Good oral hygiene and healthy periodontal tissues.
• Patients having overjet ≥ 7 mm and ≤ 10 mm and overbite of 2-3 mm.
• Pt with molar relation angle's full cusp Class II requiring symmetric extractions of maxillary 1st premolars and maximum anchorage.
• Patients having coincident maxillary midline with the facial midline.

Exclusion criteria

• Patients with maxillary anterior teeth have dilacerations, fusion, hyper-cementosis, shorter roots or any other tooth anomaly.
• Patients with traumatized or impacted teeth in the anterior maxilla.
• Patients with moderate to severe crowding in maxillary and mandibular arch.
• History of bone metabolic disorders or patients receiving drugs that alter bone metabolism.
• History of systemic diseases or hormonal imbalance that hinders orthodontic tooth movement.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group I; 6 mm height of power arm	Other: Anterior Power Arm; Crimpable stainless steel hook placed on orthodontic base arch wire.; Other Names: Anterior Retraction Hook
Experimental: Group II; 3 mm height of power arm	Other: Anterior Power Arm; Crimpable stainless steel hook placed on orthodontic base arch wire.; Other Names: Anterior Retraction Hook
Experimental: Group III; 9 mm height of power arm	Other: Anterior Power Arm; Crimpable stainless steel hook placed on orthodontic base arch wire.; Other Names: Anterior Retraction Hook

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in maxillary central incisor sagittal dimension	IoSV (mm), IaSV (mm), IaSV/IoSV	Upto 1 year
Change in maxillary central incisor vertical dimension	IoPP (mm), IaPP (mm)	Upto 1 year
Change in maxillary central incisor angular dimension	I-angle (degrees)	Upto 1 year
Change in maxillary anterior transverse dimension	Intercanine width (mm)	Upto 1 year

Collaborators and Investigators

• Sponsor: Dow University of Health Sciences
• Investigators: Principal Investigator: Tahira Arif, Dow University of Health Sciences

Study record dates

Study Major Dates

• Study Start (Actual): June 25, 2019
• Primary Completion (Actual): March 1, 2021
• Study Completion (Actual): March 1, 2021

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: December 1, 2019
• First Posted (Actual): December 3, 2019

Study Record Updates

• Last Update Posted (Actual): October 25, 2022
• Last Update Submitted That Met QC Criteria: October 22, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: TARIF

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No