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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Orthodontic Appliance

Intervention / Treatment
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* Device: Space closure without changing working archwire monthly
* Device: Space closure withchanging working archwire monthly


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 30 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Working archwire status
Masking: Double


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Tooth movement, Friction, Rate