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Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

Primary Purpose

Posterior Crossbite

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
tooth borne hyrax expander
microosteoperforation
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posterior Crossbite

Eligibility Criteria

11 Years - 14 Years (Child)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Female adolescent patients with an age range 11- 14 years.
  • Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models.
  • Normal vertical growth pattern.
  • Fully erupted maxillary first premolars and first permanent molars.

Exclusion Criteria:

  • Previous orthodontic treatment.
  • Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement.
  • Active periodontal affection or severe gingival inflammation.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    tooth borne hyrax expander group

    tooth borne hyrax expander with microosteoperforation

    Arm Description

    patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .

    patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .

    Outcomes

    Primary Outcome Measures

    Dental tipping.
    it will be measured in degree on Cone beam computed tomography image using a software
    Alveolar bending
    it will be measured in degree on Cone beam computed tomography image using a software
    Dental changes(transverse).
    it will be measured in mm on Cone beam computed tomography image using a software
    Skeletal changes(transverse, anteroposterior and vertical)
    it will be measured in mm on Cone beam computed tomography image using a software

    Secondary Outcome Measures

    Pattern of expansion
    it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.

    Full Information

    First Posted
    November 27, 2018
    Last Updated
    December 10, 2018
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03772379
    Brief Title
    Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
    Official Title
    Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2018
    Overall Recruitment Status
    Unknown status
    Study Start Date
    February 2019 (Anticipated)
    Primary Completion Date
    February 2020 (Anticipated)
    Study Completion Date
    May 2020 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    The aim of this study is to evaluate and compare the effect of rapid maxillary expansion with and without microosteoperforation in patients with skeletal maxillary constriction.Theoretically, the force generated by the activation of the Hyrax expander leads initially to the compression of the periodontal ligament, bending of the alveolar bone, and tipping of the anchor teeth. This in turn contributes to the unfavorable changes in the supporting tissues; such as root resorption, buccal crown tipping, reduction of buccal bone thickness, marginal bone loss and alveolar bone fenestration and dehiscence. In this trial, it is assumed that by reducing the cortical bone resistance, using micro-osteoperforation (MOP), the alveolar bone bending and buccal tipping that usually occur during expansion will be reduced and thus facilitating the bone expansion.
    Detailed Description
    The study consists of 2 groups that are divided divided equally and randomly.The first group will receive a tooth borne Hyrax expander supported on first premolar and first permanent molar , whereas the second group will receive the same appliance associated with microosteoperforation(MOP). The MOP will be performed on the buccal segment bilaterally along the maxilla starting from the distal of the canine till the distal of the first permanent molar. The assessment will be done using CBCT scans immediately after expansion and 6 months postretention.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Posterior Crossbite

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    34 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    tooth borne hyrax expander group
    Arm Type
    Experimental
    Arm Description
    patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars .
    Arm Title
    tooth borne hyrax expander with microosteoperforation
    Arm Type
    Experimental
    Arm Description
    patients of this group will receive a tooth borne hyrax expander anchored to the first premolars and first permanent molars and microosteoperforation .
    Intervention Type
    Device
    Intervention Name(s)
    tooth borne hyrax expander
    Intervention Description
    ready made four stainless steel bands will be supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax,.The appliance will be activated one quarter turn per day untill reaching maximum amount of lateral expansion of the jack screw. the patients will be recalled twice per week to evaluate the progress of treatment.
    Intervention Type
    Procedure
    Intervention Name(s)
    microosteoperforation
    Intervention Description
    ready made four stainless steel bands supported on the first premolars and first permanent molars and to which the palatal expander will be soldered to form the Hyrax.No activation will be provided to the hyrax expander before the micro-osteoperforation is performed. Microosteoperforation will applied bilaterally on the buccal surface between the roots of teeth at the level of mucoginival junction, starting from the distal of canine till the distal of the first permanent molar using a small sized surgical bur mounted on a hand piece .
    Primary Outcome Measure Information:
    Title
    Dental tipping.
    Description
    it will be measured in degree on Cone beam computed tomography image using a software
    Time Frame
    an average1 year
    Title
    Alveolar bending
    Description
    it will be measured in degree on Cone beam computed tomography image using a software
    Time Frame
    an average1 year
    Title
    Dental changes(transverse).
    Description
    it will be measured in mm on Cone beam computed tomography image using a software
    Time Frame
    an average1 year
    Title
    Skeletal changes(transverse, anteroposterior and vertical)
    Description
    it will be measured in mm on Cone beam computed tomography image using a software
    Time Frame
    an average1 year
    Secondary Outcome Measure Information:
    Title
    Pattern of expansion
    Description
    it will be assessed on Cone beam computed tomography image and in mm clinically with boley gauge.
    Time Frame
    an average1 year

    10. Eligibility

    Sex
    Female
    Minimum Age & Unit of Time
    11 Years
    Maximum Age & Unit of Time
    14 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Female adolescent patients with an age range 11- 14 years. Having apical constricted maxillary arch reflected by posterior cross-bite and verified through Howe's analysis on the dental study models. Normal vertical growth pattern. Fully erupted maxillary first premolars and first permanent molars. Exclusion Criteria: Previous orthodontic treatment. Any congenital anomalies, systemic disease, or asymmetries that might have an influence on tooth movement. Active periodontal affection or severe gingival inflammation.

    12. IPD Sharing Statement

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    Evaluation of Rapid Maxillary Expansion Facilitated by Micro-osteoperforation in Adolescent Patients With Skeletal Maxillary Constriction

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