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.
Full Title of Study: “Speed of Premolar Extraction Space Closure: The Effect of Every Visit Replacement of Working Arch Wire – A Prospective Randomized Clinical Trial”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: September 1, 2019
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.
- Device: Space closure without changing working archwire monthly
- Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
- Device: Space closure withchanging working archwire monthly
- Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month
Arms, Groups and Cohorts
- Experimental: Group 1
- Extraction space closed using the same working archwire throughout 3 visits after insertion
- Experimental: Group 2
- The extraction space closed having the working archwire changed monthly.
Clinical Trial Outcome Measures
- The amount of space closure per month
- Time Frame: 3 months
- the width of upper extraction space in milimeters
- ion concentration in saliva
- Time Frame: through study completion, an average of 1 year
- Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva
- Frictional resistance
- Time Frame: At the end of the study
- A mean value in N for frictional force over a 3 millimeter distance.
Participating in This Clinical Trial
- 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
- Poor oral hygiene
- Diseases and medications that were likely to affect bone biology
- Previous orthodontic treatment
- Evidence of bone loss
- Active periodontal disease
Gender Eligibility: All
Minimum Age: 16 Years
Maximum Age: 30 Years
Are Healthy Volunteers Accepted: Accepts Healthy Volunteers
- Lead Sponsor
- Jordan University of Science and Technology
- Provider of Information About this Clinical Study
- Principal Investigator: Elham Abu Alhaija, Professor – Jordan University of Science and Technology
- Overall Official(s)
- Elham S A Alhaija, PhD, Principal Investigator, Jordan University of Science and Technology
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