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CompletedNCT04549987Updated Sep 22, 2020

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

An interventional study of Space closure without changing working archwire monthly and Space closure withchanging working archwire monthly in Orthodontic Appliance, sponsored by Jordan University of Science and Technology. Completed at 1 site in Jordan. Open to participants aged 16 Years to 30 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-09-22.

Sponsored by Jordan University of Science and Technology · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 1 year 9 months after the study started (first participant enrolled Dec 2018, registered Sep 2020).
Phase
Not applicable
Study type
Interventional
Enrollment
28
Allocation
Randomized
Ages
16 Years to 30 Years
Sex
All
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Study 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.

Read the 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.

02

Conditions studied

  • Orthodontic Appliance

Keywords

  • Tooth movement
  • Friction
  • Rate
03

In context

Lead sponsor

Jordan University of Science and Technology is the lead sponsor of 88 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
16 Years to 30 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
28 participants (actual)

Study arms

  • 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

  • Experimental
    With changing working archwire

    The extraction space closed having the working archwire changed monthly.

    Device: Space closure withchanging working archwire monthly

Interventions

  • DeviceSpace closure without changing working archwire monthly

    Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month

  • DeviceSpace closure withchanging working archwire monthly

    Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month

06

What researchers measure

Primary outcomes

  1. The amount of space closure per month

    the width of upper extraction space in milimeters

    Time frame: 3 months

Secondary outcomes

  1. ion concentration in saliva

    Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva

    Time frame: through study completion, an average of 1 year

  2. Frictional resistance

    A mean value in N for frictional force over a 3 millimeter distance.

    Time frame: At the end of the study

07

Study locations

1 site
  • Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics
    Irbid, Jordan
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04549987
Lead sponsor
Jordan University of Science and Technology
Responsible party
Elham Abu Alhaija (Professor, Jordan University of Science and Technology) — Principal investigator
First posted
Sep 16, 2020
Start date
Dec 1, 2018
Primary completion
Sep 1, 2019
Completion
Aug 31, 2020
Last update
Sep 22, 2020

Study contacts

Elham S A Alhaija, PhD
principal investigator · Jordan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2020. You cannot join it, but the record below documents what was studied.

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