Speed of Premolar Extraction Space Closure: Every Visit Replacement of Working Archwire

Speed of Premolar Extraction Space Closure: The Effect of Every Visit Replacement of Working Arch Wire - A Prospective Randomized Clinical Trial

The aims of this trial were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro, and to assess its effect on the rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure.

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance
• Intervention / Treatment: Device: Space closure without changing working archwire monthly; Device: Space closure withchanging working archwire monthly

Detailed Description

The aims were to assess the effect of changing 0.019X0.025-inch SS working archwire monthly on the rate of space closure, to compare the frictional resistance of unchanged and new working archwires in-vitro and to assess its effect on rate of space closure, to record the amount of ion concentration in the saliva before orthodontic treatment, before space closure and one month after space closure and to compare the rate of teeth movement into fresh and old extraction sites.

Trial design: Randomized controlled clinical trial with a split-mouth design. Setting: Jordan University of Science and Technology(JUST) Postgraduate Dental Teaching Clinics and labs.

Participants and interventions: Twenty-eight subjects with bimaxillary proclination requiring extraction of all first premolar teeth participated in this study. In the upper arch two groups were identified; group 1 having the extraction space closed using the same working archwire throughout 3 visits after insertion, and group 2 with the working archwire changed monthly.

The working archwire in the upper arch was split into 2 halves in the midline and each one half was connected to the other by a wide joining hook. Patients were followed-up monthly for three months. At every follow up visit upper alginate impressions were taken and the working archwire in the upper arch was changed on one side only. Upper follow-up models were scanned using digital scanner and spaces were measured using digital software.

Three unstimulated saliva samples were collected from each patient; prior to commencement of treatment, when 0.019X0.25-inch SS archwire was reached and before space closure and one month after space closure.

The rate of extraction space closure in the upper arch, ion concentration in saliva samples measured using inductively coupled plasma mass spectrometer (ICP-MS) and frictional resistance of the working archwires was measured using universal mechanical testing machine.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Jordan
  • Irbid, Jordan
    • Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Age ≥ 16 years
• Proclined upper and lower incisors (Ui/max >115 o, Li/mand >99o)
• Mild upper and lower arch crowding (<4mm) or no crowding
• Need for upper and lower first premolars extraction
• Skeletal I malocclusion (1<ANB <5)
• Average lower facial height and maxillomandibular plane angle (22 o <MM<32 o)
• Class I canine relationship
• Good oral hygiene and healthy periodontium

Exclusion Criteria:

• Poor oral hygiene
• Diseases and medications that were likely to affect bone biology
• Previous orthodontic treatment
• Evidence of bone loss
• Active periodontal disease
• Smoking

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Without changing working archwire; Extraction space closed using the same working archwire throughout 3 visits after insertion	Device: Space closure without changing working archwire monthly; Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
Experimental: With changing working archwire; The extraction space closed having the working archwire changed monthly.	Device: Space closure withchanging working archwire monthly; Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The amount of space closure per month	the width of upper extraction space in milimeters	3 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ion concentration in saliva	Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva	through study completion, an average of 1 year
Frictional resistance	A mean value in N for frictional force over a 3 millimeter distance.	At the end of the study

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Elham S A Alhaija, PhD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): August 31, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: September 9, 2020
• First Posted (Actual): September 16, 2020

Study Record Updates

• Last Update Posted (Actual): September 22, 2020
• Last Update Submitted That Met QC Criteria: September 19, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Friction; Rate; Tooth movement
• Other Study ID Numbers: 53/2019

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