Metal ArtifactsNCT04935944
Effect of FOV and mA on Metal Artifacts on CBCT
An observational study of Metal Artifacts and Implant, run by Cairo University at 1 site in Egypt.
Trial summary
The aim of this study is to evaluate the effect of exposure parameters as milliampere (mA) and field of view (FOV) in CBCT on metal artifact of dental implant. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metal Artifacts, Implant
- What is being tested?
- CBCT radiation
- Type of treatment
- Surgery or procedure
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 7 Jul 2021to 2 Apr 2023
- Phase
- Observational
- 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
Study population: Using different dry human mandibles with dummy implants.
Who may be able to join
- Bio models of jaw with dummy implant.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Variations of Field of View (FOV) and Milliampere (mA) on Metal Artifacts Produced by Dental Implants in Cone Beam Computed Tomography Image Quality. (In-vitro Study)
The aim of this study is to evaluate the effect of exposure parameters as milliampere (mA) and field of view (FOV) in CBCT on metal artifact of dental implant.
Read the detailed description
Cone Beam Computed Tomography (CBCT) is considered an important valuable imaging technique in the diagnosis and treatment planning in oral and maxillofacial surgery as well as implant dentistry by means of three dimensional images which provide extra information about the buccolingual dimension of the alveolar bone with more details for bone anatomy and inclination.
To make an accurate diagnosis and treatment planning, we have to obtain images with more details and good resolution and quality which could be achieved by CBCT. However, there are some issues in scanned areas that can affect their quality such as presence of metals (metallic restorations, orthodontic appliances, dental implants, crowns) which result in artifacts which can be considered as an important cause of poor image quality which will lead to poor diagnosis.
There are many types of artifacts which can be observed on CBCT images. Beam hardening artifact is considered a common one which occurs when an x-ray beam comprised of polychromatic energies passes through an object, resulting in selective attenuation of lower energy photons. The effect is conceptually similar to a high-pass filter, in that only higher energy photons are left to contribute to the beam and thus the mean beam energy is increased ("hardened").
- Conditions
- Metal Artifacts, Implant
- Being tested
- CBCT radiation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBCT radiationRadiation
CBCT scanning
| Study group | Role | What they receive |
|---|---|---|
| Tube potential difference (FOV) | Using different FOV and mA values of the CBCT machine Receives: Radiation: CBCT radiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental implant linear measurement
The implant length and width in millimeters will be assessed in the presence of the artifacts with change in the potential difference of FOV and mA
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start7 Jul 2021
- Primary completion9 Mar 2023
- Study completion2 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metal ArtifactsStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Roshan Adel Ahmed Elsayed, Cairo University
- Investigators
- Noha Issa, Associate Prof, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04935944
- Sponsor's protocol ID
- ORAD-CU-2021
- Status last verified
- Oct 2024
- First submitted
- 15 Jun 2021
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Variations of Field of View (FOV) and Milliampere (mA) on Metal Artifacts Produced by Dental Implants in Cone Beam Computed Tomography Image Quality. (In-vitro Study)
- ClinicalTrials.gov ID
- NCT04935944
- Acronym / sponsor ID
- ORAD-CU-2021
- Conditions
- Metal Artifacts, Implant
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 9 Mar 2023 (actual)
- Study completion
- 2 Apr 2023 (actual)
- First posted
- 23 Jun 2021 (actual)
- 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.
The aim of this study is to evaluate the effect of exposure parameters as milliampere (mA) and field of view (FOV) in CBCT on metal artifact of dental implant.
Detailed description
Cone Beam Computed Tomography (CBCT) is considered an important valuable imaging technique in the diagnosis and treatment planning in oral and maxillofacial surgery as well as implant dentistry by means of three dimensional images which provide extra information about the buccolingual dimension of the alveolar bone with more details for bone anatomy and inclination.
To make an accurate diagnosis and treatment planning, we have to obtain images with more details and good resolution and quality which could be achieved by CBCT. However, there are some issues in scanned areas that can affect their quality such as presence of metals (metallic restorations, orthodontic appliances, dental implants, crowns) which result in artifacts which can be considered as an important cause of poor image quality which will lead to poor diagnosis.
There are many types of artifacts which can be observed on CBCT images. Beam hardening artifact is considered a common one which occurs when an x-ray beam comprised of polychromatic energies passes through an object, resulting in selective attenuation of lower energy photons. The effect is conceptually similar to a high-pass filter, in that only higher energy photons are left to contribute to the beam and thus the mean beam energy is increased ("hardened").
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Tube potential difference (FOV) | – | Radiation: CBCT radiationUsing different FOV and mA values of the CBCT machine |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Using different dry human mandibles with dummy implants.
Key inclusion criteria (1 listed)
- Bio models of jaw with dummy implant.
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| CBCT radiationCBCT scanning | Radiation | Tube potential difference (FOV) |
Primary outcome
Dental implant linear measurement
Time frame: 2 months
The implant length and width in millimeters will be assessed in the presence of the artifacts with change in the potential difference of FOV and mA
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 24 Oct 2024.
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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.
Noha Issa, Associate Prof study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Metal Artifacts and Implant, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 1 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 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Dental implant linear measurement (time frame: 2 months). 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 24 Oct 2024.