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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04598490
Other study ID # 53b/2019
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date December 1, 2018
Est. completion date August 1, 2020

Study information

Verified date September 2021
Source Jordan University of Science and Technology
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim was to compare the rate of teeth movement into fresh and old extraction sites.


Description:

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 lower arch, two groups were also identified; group 1 having the first premolar extracted before the commencement of orthodontic treatment and group 2 having the first premolar extracted just before space closure when 0.019 x 0.025 inch SS archwire was reached. Patients were followed-up monthly for three months. At every follow-up visit lower alginate impressions were taken. Extraction spaces in the lower arch follow-up models were measured using digital caliper. The rate of extraction space closure in the lower arch was assessed monthly.


Recruitment information / eligibility

Status Completed
Enrollment 28
Est. completion date August 1, 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 into old extraction space
Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket
Space closure into recent extraction space
Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket

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 Amount of space closure Width of extraction space will be measured in millimeters 3 months
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