Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site

Speed of Premolar Extraction Space Closure: Healed vs Recent Extraction Site- A Prospective Randomized Clinical Trial

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

Study Overview

• Status: Completed
• Conditions: Orthodontic Appliance
• Intervention / Treatment: Device: Space closure into old extraction space; Device: Space closure into recent extraction space

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 28
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 30 years (Child, Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Healed extraction site; Old Extraction Space	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
Experimental: unhealed extraction site; Recent Extraction space	Device: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Amount of space closure	Width of extraction space will be measured in millimeters	3 months

Collaborators and Investigators

• Sponsor: Jordan University of Science and Technology
• Investigators: Principal Investigator: Elham S A Alhaija, PhD, Jordan University of Science and Technology

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2018
• Primary Completion (Actual): September 1, 2019
• Study Completion (Actual): August 1, 2020

Study Registration Dates

• First Submitted: September 9, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 22, 2020

Study Record Updates

• Last Update Posted (Actual): October 4, 2021
• Last Update Submitted That Met QC Criteria: September 27, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Keywords: recent; healed; extraction space
• Other Study ID Numbers: 53b/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No