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

Sponsor
Cairo University (Other)
Overall Status
Recruiting
CT.gov ID
NCT04151875
Collaborator
(none)
30
Enrollment
1
Location
2
Arms
13.4
Anticipated Duration (Months)
2.2
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Extraction orthodontic treatment
  • Device: Non-extraction orthodontic treatment
 N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
30 participants
Allocation:
Non-Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
-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.-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.
Masking:
Single (Outcomes Assessor)
Masking Description:
the outcome assessor will be masked about the group of the participant during the measuring the outcome ..
Primary Purpose:
Treatment
Official Title:
Effect of Extraction Versus Non-extraction Orthodontic Treatment on Vertical Facial Dimension: A Non-Randomized Clinical Trial
Actual Study Start Date :
Jun 1, 2021
Anticipated Primary Completion Date :
Jun 1, 2022
Anticipated Study Completion Date :
Jul 15, 2022

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Changes in Vertical Dimension (VD) [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

    Secondary Outcome Measures

    1. Changes in Overbite [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    11 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Hasan Hasan Cairo Egypt 11559

    Sponsors and Collaborators

    • 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 Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hasan Abdullah Naji Hasan, Principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04151875
    Other Study ID Numbers:
    • ORTH 3-3-4 CU
    First Posted:
    Nov 5, 2019
    Last Update Posted:
    Apr 7, 2022
    Last Verified:
    Mar 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Hasan Abdullah Naji Hasan, Principal investigator, Cairo University
    orthodontics
    vertical dimension
    premolars extraction
    long face
    Additional relevant MeSH terms:
    Malocclusion

    Study Results

    No Results Posted as of Apr 7, 2022