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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04549987
Enrollment
28
Registered
2020-09-16
Start date
2018-12-01
Completion date
2020-08-31
Last updated
2020-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Orthodontic Appliance

Keywords

Tooth movement, Friction, Rate

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.

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.

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

Sponsors

Jordan University of Science and Technology
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, 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.

Intervention model description

Working archwire status

Eligibility

Sex/Gender
ALL
Age
16 Years to 30 Years
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

Design outcomes

Primary

MeasureTime frameDescription
The amount of space closure per month3 monthsthe width of upper extraction space in milimeters

Secondary

MeasureTime frameDescription
ion concentration in salivathrough study completion, an average of 1 yearConcentration of ions (Chrome, Iron, Nickel, titanium) in saliva
Frictional resistanceAt the end of the studyA mean value in N for frictional force over a 3 millimeter distance.

Countries

Jordan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026