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Radiological Examination of the Mentally Handicapped Patients

Primary Purpose

Profound Mental Retardation

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Radiological examination
Sponsored by
Tokat Gaziosmanpasa University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Profound Mental Retardation focused on measuring Cone-Beam Computed Tomography, Mentally Handicapped

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Mentally Handicapped patients that radiological examination cannot performed
  2. Suitable for IV sedation

Exclusion Criteria:

  1. Healthy Patients
  2. Patients in which the radiological examination performed

Sites / Locations

    Arms of the Study

    Arm 1

    Arm Type

    Other

    Arm Label

    Radiological imaging

    Arm Description

    Mentally handicapped patients underwent sedation anesthesia with IV Propofol and then tomographic images were obtained with NewTom 5G. Orthopantomographies (OPGs) were obtained by processing the raw images and radiological examination of the patients were performed on OPGs.

    Outcomes

    Primary Outcome Measures

    Comparison of the radiological and oral examinations in mentally handicapped patients
    Radiological images of the mentally handicapped patients obtained under sedation anesthesia with cone beam dental tomography. Radiological examination were performed on tomograpic images and indications (tooth filling, root canal treatment, extraction) were noted. Same procedure was performed for oral examination and indications were compared.

    Secondary Outcome Measures

    Full Information

    First Posted
    February 24, 2016
    Last Updated
    April 12, 2016
    Sponsor
    Tokat Gaziosmanpasa University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02741011
    Brief Title
    Radiological Examination of the Mentally Handicapped Patients
    Official Title
    Computed Tomographic Assessment of the Maxillofacial Region of Mentally Handicapped or Uncooperative Patients Under Intravenous Sedation
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Completed
    Study Start Date
    February 2012 (undefined)
    Primary Completion Date
    February 2014 (Actual)
    Study Completion Date
    February 2014 (Actual)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    Aim of this study is to evaluate the necessity of the radiological examinations of mentally handicapped or uncooperative patients.
    Detailed Description
    Dental radiography has become an indispensable part of routine dental examination with the help of the technological development of radiological devices. However, medical procedures like dental treatment and medical imaging (magnetic resonance imaging-MRI, computed tomography-CT, orthopantomography- OPG, etc.) that require cooperation are usually hard to apply to mentally handicapped (MHP) or uncooperative patients (UCP). Treatments that will be done without radiological examination can be missing or incorrect.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Profound Mental Retardation
    Keywords
    Cone-Beam Computed Tomography, Mentally Handicapped

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    98 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Radiological imaging
    Arm Type
    Other
    Arm Description
    Mentally handicapped patients underwent sedation anesthesia with IV Propofol and then tomographic images were obtained with NewTom 5G. Orthopantomographies (OPGs) were obtained by processing the raw images and radiological examination of the patients were performed on OPGs.
    Intervention Type
    Other
    Intervention Name(s)
    Radiological examination
    Intervention Description
    During the period of two years, mentally handicapped patients were enrolled in this study. First a radiological examination was performed under sedation anesthesia and then an oral examination was performed when patient underwent general anesthesia for dental treatments. Oral and radiological examinations were compared with each other and also with treatment results to define the necessity of the radiological examination of mentally handicapped patients.
    Primary Outcome Measure Information:
    Title
    Comparison of the radiological and oral examinations in mentally handicapped patients
    Description
    Radiological images of the mentally handicapped patients obtained under sedation anesthesia with cone beam dental tomography. Radiological examination were performed on tomograpic images and indications (tooth filling, root canal treatment, extraction) were noted. Same procedure was performed for oral examination and indications were compared.
    Time Frame
    2 years

    10. Eligibility

    Sex
    All
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Mentally Handicapped patients that radiological examination cannot performed Suitable for IV sedation Exclusion Criteria: Healthy Patients Patients in which the radiological examination performed

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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    Radiological Examination of the Mentally Handicapped Patients

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