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

Sponsor

Jordan University of Science and Technology (Other)

Overall Status

Completed

CT.gov ID

NCT04598490

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

1.4

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Orthodontic Appliance	Device: Space closure into old extraction space Device: Space closure into recent extraction space	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

28 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Space closure into old extraction spaceSpace closure into old extraction space

Masking:

Double (Participant, Outcomes Assessor)

Masking Description:

After recruiting patients who met the inclusion criteria, 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.

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Dec 1, 2018

Actual Primary Completion Date :

Sep 1, 2019

Actual Study Completion Date :

Aug 1, 2020

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 30 Years

Sexes Eligible for Study:

All

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Faculty of Dentistry/Jordan University of Science and Technology Dental Teaching Clinics	Irbid		Jordan

Sponsors and Collaborators

Jordan University of Science and Technology

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Elham Abu Alhaija, Professor, Jordan University of Science and Technology

ClinicalTrials.gov Identifier:

NCT04598490

Other Study ID Numbers:

53b/2019

First Posted:

Oct 22, 2020

Last Update Posted:

Oct 4, 2021

Last Verified:

Sep 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Elham Abu Alhaija, Professor, Jordan University of Science and Technology

recent

healed

extraction space

Study Results

No Results Posted as of Oct 4, 2021