Radiological Examination of the Mentally Handicapped Patients

April 12, 2016 updated by: Emrah Soylu, Tokat Gaziosmanpasa University

Computed Tomographic Assessment of the Maxillofacial Region of Mentally Handicapped or Uncooperative Patients Under Intravenous Sedation

Aim of this study is to evaluate the necessity of the radiological examinations of mentally handicapped or uncooperative patients.

Study Overview

Status

Completed

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

98

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Radiological imaging
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the radiological and oral examinations in mentally handicapped patients
Time Frame: 2 years
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.
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

February 1, 2014

Study Completion (Actual)

February 1, 2014

Study Registration Dates

First Submitted

February 24, 2016

First Submitted That Met QC Criteria

April 12, 2016

First Posted (Estimate)

April 18, 2016

Study Record Updates

Last Update Posted (Estimate)

April 18, 2016

Last Update Submitted That Met QC Criteria

April 12, 2016

Last Verified

April 1, 2016

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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