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

NCT ID: NCT04598490

Last Updated: 2021-10-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-01

Study Completion Date

2020-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Orthodontic Appliance

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Space closure into old extraction space
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
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.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Healed extraction site

Old Extraction Space

Group Type EXPERIMENTAL

Space closure into old extraction space

Intervention Type DEVICE

Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into healed bony socket

unhealed extraction site

Recent Extraction space

Group Type EXPERIMENTAL

Space closure into recent extraction space

Intervention Type DEVICE

Lower first premolar extraction space was closed using elastic power chain and 0.019X0.025 Stainless steel archwire into fresh bony socket

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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

Intervention Type 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

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

16 Years

Maximum Eligible Age

30 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Jordan University of Science and Technology

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Elham Abu Alhaija

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Elham S A Alhaija, PhD

Role: PRINCIPAL_INVESTIGATOR

Jordan University of Science and Technology

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Irbid, , Jordan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Jordan

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

53b/2019

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.