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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04549987
Other study ID # 53/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date August 31, 2020

Study information

Verified date September 2020
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 31, 2020
Est. primary completion date September 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 16 Years to 30 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Device:
Space closure without changing working archwire monthly
Upper premolar space closure using the same 0.019X0.025 stainless steel archwire every month
Space closure withchanging working archwire monthly
Upper premolar space closure using new 0.019X0.025 stainless steel archwire every month

Locations

Country Name City State
Jordan Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics Irbid

Sponsors (1)

Lead Sponsor Collaborator
Jordan University of Science and Technology

Country where clinical trial is conducted

Jordan, 

Outcome

Type Measure Description Time frame Safety issue
Primary The amount of space closure per month the width of upper extraction space in milimeters 3 months
Secondary ion concentration in saliva Concentration of ions (Chrome, Iron, Nickel, titanium) in saliva through study completion, an average of 1 year
Secondary Frictional resistance A mean value in N for frictional force over a 3 millimeter distance. At the end of the study
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