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

Orthodontic Appliance Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04549987
• Other study ID #: 53/2019
• Status: Completed
• Phase: N/A
• Start date: December 1, 2018
• Est. completion date: August 31, 2020

Study information

• Verified date: September 2020
• Source: Jordan University of Science and Technology
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: August 31, 2020
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 30 Years

Eligibility

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

Related Conditions & MeSH terms

• Orthodontic Appliance

Intervention

Device:
• Space closure without changing working archwire monthly
Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
• Space closure withchanging working archwire monthly
Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month

Locations

Country	Name	City	State
Jordan	Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics	Irbid

Sponsors (1)

Lead Sponsor	Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The amount of space closure per month	the width of upper extraction space in milimeters	3 months
Secondary	ion concentration in saliva	Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva	through study completion, an average of 1 year
Secondary	Frictional resistance	A mean value in N for frictional force over a 3 millimeter distance.	At the end of the study