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Completed

NCT Number: NCT04549987

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

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.

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Key information

Age range

16 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics

Irbid, Jordan

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Space closure without changing working archwire monthly

Device

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

Space closure withchanging working archwire monthly

Device

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

Primary outcomes

  1. The amount of space closure per month

    Time frame: 3 months

    the width of upper extraction space in milimeters

Secondary outcomes

  1. ion concentration in saliva

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

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

  2. Frictional resistance

    Time frame: At the end of the study

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

Sponsors and collaborators

Lead sponsor

Jordan University of Science and Technology

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2019
Study completion
2020
First posted
Sep 16, 2020
Registry last updated
Sep 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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