Profound Mental RetardationNCT02741011
Radiological Examination of the Mentally Handicapped Patients
A study testing Radiological examination in people with Profound Mental Retardation, run by Tokat Gaziosmanpasa University.
Trial summary
Aim of this study is to evaluate the necessity of the radiological examinations of mentally handicapped or uncooperative patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Profound Mental Retardation
- What is being tested?
- Radiological examination
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2014
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Mentally Handicapped patients that radiological examination cannot performed
- Suitable for IV sedation
Who cannot join
- Healthy Patients
- Patients in which the radiological examination performed
About this study
Official title: 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.
Read the 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.
- Conditions
- Profound Mental Retardation
- Being tested
- Radiological examination
- Keywords
- Cone-Beam Computed Tomography, Mentally Handicapped
- Medical subject headings
- Intellectual Disability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Radiological examinationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Radiological examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2016 (estimated)
- Study startFeb 2012
- Primary completionFeb 2014
- Study completionFeb 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Profound Mental RetardationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tokat Gaziosmanpasa University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Emrah Soylu, Tokat Gaziosmanpasa University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02741011
- Sponsor's protocol ID
- ES-Tez01
- Status last verified
- Apr 2016
- First submitted
- 24 Feb 2016
- Last updated
- 18 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Computed Tomographic Assessment of the Maxillofacial Region of Mentally Handicapped or Uncooperative Patients Under Intravenous Sedation
- ClinicalTrials.gov ID
- NCT02741011
- Acronym / sponsor ID
- ES-Tez01
- Conditions
- Profound Mental Retardation
- Keywords
- Cone-Beam Computed Tomography, Mentally Handicapped
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Tokat Gaziosmanpasa UniversityUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 18 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Radiological imaging | Other | Other: Radiological examinationMentally 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Mentally Handicapped patients that radiological examination cannot performed
- Suitable for IV sedation
Key exclusion criteria (2 listed)
- Healthy Patients
- Patients in which the radiological examination performed
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Radiological examinationDuring 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. | Other | Radiological imaging |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Radiological examination in people with Profound Mental Retardation, run by Tokat Gaziosmanpasa University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of the radiological and oral examinations in mentally handicapped patients (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2016.