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

NCT ID: NCT04151875

Last Updated: 2022-04-07

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

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-06-01

Study Completion Date

2022-07-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Malocclusion Long Face Syndrome Crowding, Tooth

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

-Interventions Intervention Group (I) Extraction treatment group. Bonding all cases will be performed by the principal investigator, then premolars extraction will be done, then installing the 1st alignment wire.

Comparator group (C):

Non-extraction group. Same orthodontist will bond all the cases and install the 1st alignment wire.
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
the outcome assessor will be masked about the group of the participant during the measuring the outcome ..

Study Groups

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Extraction orthodontic treatment

orthodontic treatment with teeth extraction

Group Type EXPERIMENTAL

Extraction orthodontic treatment

Intervention Type DEVICE

orthodontic treatment with teeth extraction

Non-extraction orthodontic treatment

non-extraction orthodontic treatment

Group Type ACTIVE_COMPARATOR

Non-extraction orthodontic treatment

Intervention Type DEVICE

Non-extraction orthodontic treatment

Interventions

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Extraction orthodontic treatment

orthodontic treatment with teeth extraction

Intervention Type DEVICE

Non-extraction orthodontic treatment

Non-extraction orthodontic treatment

Intervention Type DEVICE

Other Intervention Names

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Braces with teeth extraction Braces with no extraction of teeth

Eligibility Criteria

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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.
Minimum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hasan Abdullah Naji Hasan

Principal investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hasan A Alrubaie, MSc

Role: PRINCIPAL_INVESTIGATOR

Orthodontic department, Faculty of Dentistry, Cairo University

Amira A Aboulnaga, PhD

Role: STUDY_DIRECTOR

Orthodontic department, Faculty of Dentistry, Cairo University

Mai H Aboulfotouh, PhD

Role: STUDY_DIRECTOR

Orthodontic department, Faculty of Dentistry, Cairo University

Amr E El dakroury, Prof.

Role: STUDY_CHAIR

Orthodontic department, Faculty of Dentistry, Cairo University

Locations

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Hasan Hasan

Cairo, , Egypt

Site Status RECRUITING

Countries

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Egypt

Central Contacts

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Hasan A Alrubaie, MSc

Role: CONTACT

+201124777315

Amira A Aboulnaga, PhD ortho

Role: CONTACT

+201000505688

Facility Contacts

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Hasan a Hasan, MSc

Role: primary

01124777315

amira a aboalnaga, PhD

Role: backup

Other Identifiers

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ORTH 3-3-4 CU

Identifier Type: -

Identifier Source: org_study_id

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