- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02741011
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
Conditions
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:
- Mentally Handicapped patients that radiological examination cannot performed
- Suitable for IV sedation
Exclusion Criteria:
- Healthy Patients
- 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.
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- ES-Tez01
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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