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

Sponsor

Jordan University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04549987

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Appliance	Device: Space closure without changing working archwire monthly Device: Space closure withchanging working archwire monthly	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Working archwire statusWorking archwire status

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

The intervention was randomly allocated to either the right or left side using the permuted random block size of 2 with 1:1 allocation ratio. The random sequences for each intervention to either right or left sides was concealed in opaque envelopes and shuffled before the intervention to increase the unpredictability of the random allocation sequence. Each patient was asked to pick a sealed envelope to assign the intervention to either the right or left side. Allocation concealment was aimed to prevent selection bias and to protect the assignment sequence until allocation.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Aug 31, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

The amount of space closure per month [3 months]
the width of upper extraction space in milimeters

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics	Irbid		Jordan

Sponsors and Collaborators

Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elham Abu Alhaija, Professor, Jordan University of Science and Technology

ClinicalTrials.gov Identifier:

NCT04549987

Other Study ID Numbers:

53/2019

First Posted:

Sep 16, 2020

Last Update Posted:

Sep 22, 2020

Last Verified:

Sep 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elham Abu Alhaija, Professor, Jordan University of Science and Technology

Tooth movement

Friction

Rate

Study Results

No Results Posted as of Sep 22, 2020