Effect of Extraction Vs Non-extraction Orthodontic Treatment on Vertical Facial Dimension

March 30, 2022 updated by: Hasan Abdullah Naji Hasan, Cairo University

Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial

The aim of the current clinical trial was to evaluate the effects of premolar extractions compared with non-extraction orthodontic treatment on the skeletal vertical dimension of the face.

The null-hypothesis is that there is no difference in post-treatment skeletal vertical characteristics of normodivergent and hyperdivergent patients treated orthodontically with first premolar extractions compared with patients treated in non-extraction manner.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The current protocol will be submitted for partial fulfillment of the PhD requirements in Faculty of Dentistry, Cairo University.

The trial will be conducted in the outpatient clinic of the Orthodontic Department, Faculty of Dentistry, Cairo University.

Primary examination and diagnosis of the patients seeking orthodontic treatment will be performed, to select a sample of the trial.

then, final diagnosis and planing of each participant will be performed by a trained orthodontists to be sure that all patients fallen with the inclusion criteria.

Interventions will be conducted with the same orthodontist, under supervision of orthodontic professors in the Orthodontic department, Cairo University.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

11 years and older (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Normodivergent and hyperdivergent patients
  • Cases with moderate crowding.
  • Borderline cases which could be treated with extraction or non-extraction strategies

Exclusion Criteria:

  • Hypodivergent patients.
  • Cases with extremely sever crowding.
  • Patients with high caries index or periodontal problems.
  • Patients with systemic diseases, or syndromic conditions.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Extraction orthodontic treatment
orthodontic treatment with teeth extraction
Device: Extraction orthodontic treatment
orthodontic treatment with teeth extraction
Other Names:
  • Braces with teeth extraction
ACTIVE_COMPARATOR: Non-extraction orthodontic treatment
non-extraction orthodontic treatment
Device: Non-extraction orthodontic treatment
Non-extraction orthodontic treatment
Other Names:
  • Braces with no extraction of teeth

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Vertical Dimension (VD)
Time Frame: after 1year. Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Vertical dimension of the face will be assessed by measuring a distances in millimeters between vertical points as ANS-Me (lower facial height), also it will be measured form angles in a degrees as angle SN/MP
after 1year. Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in Overbite
Time Frame: 1 year . Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention
Distances in millimeters will be measure directly in patient mouth by using caliper it will be measured in millimeters.
1 year . Changes will be measured before the start of trial and at the end of space closing stage, which anticipated to be within 12 months of intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Investigators

  • Principal Investigator: Hasan A Alrubaie, MSc, Orthodontic department, Faculty of Dentistry, Cairo University
  • Study Director: Amira A Aboulnaga, PhD, Orthodontic department, Faculty of Dentistry, Cairo University
  • Study Director: Mai H Aboulfotouh, PhD, Orthodontic department, Faculty of Dentistry, Cairo University
  • Study Chair: Amr E El dakroury, Prof., Orthodontic department, Faculty of Dentistry, Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2021

Primary Completion (ANTICIPATED)

June 1, 2022

Study Completion (ANTICIPATED)

July 15, 2022

Study Registration Dates

First Submitted

October 18, 2019

First Submitted That Met QC Criteria

November 1, 2019

First Posted (ACTUAL)

November 5, 2019

Study Record Updates

Last Update Posted (ACTUAL)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 30, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORTH 3-3-4 CU

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

it will be shareable for any researcher

IPD Sharing Time Frame

within month it will be ready

IPD Sharing Access Criteria

no special criteria..any orthodontic researcher can access the data

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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