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Root Resorption After Maxillary Expansion

Primary Purpose

Maxillary Expansion

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
maxillary expansion
Sponsored by
Al-Azhar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Expansion focused on measuring expanders

Eligibility Criteria

10 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: skeletal maxillary transvers deficiency unilateral or bilateral posterior crossbite negative buccal corridor patient with good oral hygiene patient with no previous orthodontic treatment no systemic disease Exclusion Criteria: craniofacial congenital anomalies a history of periodontal disease incomplete treatment records

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    hyrax group

    hybrid hyrax group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Change in root resorption after maxillary expansion
    A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances

    Secondary Outcome Measures

    Full Information

    First Posted
    September 14, 2023
    Last Updated
    September 22, 2023
    Sponsor
    Al-Azhar University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06059807
    Brief Title
    Root Resorption After Maxillary Expansion
    Official Title
    A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances (Expanders)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    September 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    January 1, 2024 (Anticipated)
    Primary Completion Date
    January 2025 (Anticipated)
    Study Completion Date
    February 2025 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Al-Azhar University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    The aim of this study will to evaluate the root resorption after RME by hyrax and hybrid hyrax appliances by using of cone beam computed tomography .

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Maxillary Expansion
    Keywords
    expanders

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    hyrax group
    Arm Type
    Experimental
    Arm Title
    hybrid hyrax group
    Arm Type
    Experimental
    Intervention Type
    Device
    Intervention Name(s)
    maxillary expansion
    Intervention Description
    Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances
    Primary Outcome Measure Information:
    Title
    Change in root resorption after maxillary expansion
    Description
    A Cone-Beam Computed Tomography Evaluation of Root Resorption After Maxillary Expansion Using Hyrax and Hybrid Hyrax Appliances
    Time Frame
    12 weeks following end of treatment

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    16 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: skeletal maxillary transvers deficiency unilateral or bilateral posterior crossbite negative buccal corridor patient with good oral hygiene patient with no previous orthodontic treatment no systemic disease Exclusion Criteria: craniofacial congenital anomalies a history of periodontal disease incomplete treatment records
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    mohamed taher aboghalia, master
    Phone
    01063534515
    Email
    mohamedtaher606@gmail.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    mostafa mohamed dowaba, PhD
    Phone
    01114037884

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    34509329
    Citation
    Miranda F, Cunha Bastos JCD, Magno Dos Santos A, Janson G, Pereira Lauris JR, Garib D. Dentoskeletal comparison of miniscrew-anchored maxillary protraction with hybrid and conventional hyrax expanders: A randomized clinical trial. Am J Orthod Dentofacial Orthop. 2021 Dec;160(6):774-783. doi: 10.1016/j.ajodo.2021.02.017. Epub 2021 Sep 9.
    Results Reference
    result
    Links:
    URL
    https://pubmed.ncbi.nlm.nih.gov/34509329/
    Description
    Related Info

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    Root Resorption After Maxillary Expansion

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