Radiological Examination of the Mentally Handicapped Patients

NCT02741011 | Completed DMC

• 1 other identifier: ES-Tez01
• Study Type: interventional
• Target: 98
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Profound Mental Retardation

Keywords

Cone-Beam Computed Tomography; Mentally Handicapped

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Study Arms (1)

Radiological imaging

OTHER

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.

Other: Radiological examination

Interventions

Radiological examination OTHER

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.

Radiological imaging

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Mentally Handicapped patients that radiological examination cannot performed
• Suitable for IV sedation

You may not qualify if:

• Healthy Patients
• Patients in which the radiological examination performed

Sponsors & Collaborators

• Tokat Gaziosmanpasa University: lead

MeSH Terms

Conditions

Intellectual Disability

Interventions

X-Rays

Condition Hierarchy (Ancestors)

Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Electromagnetic Radiation; Electromagnetic Phenomena; Magnetic Phenomena; Physical Phenomena; Radiation; Radiation, Ionizing

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Asistan Professor

Study Record Dates

• First Submitted: February 24, 2016
• First Posted: April 18, 2016
• Study Start: February 1, 2012
• Primary Completion: February 1, 2014
• Study Completion: February 1, 2014
• Last Updated: April 18, 2016

Record last verified: 2016-04

Data Sharing

• IPD Sharing: Will not share