Metal ArtifactsDTANCT03726970
Effect of Metal Artifacts Reduction Orotocols and Electric Potential Difference on Metal Artifacts in Cone Beam Computed Tomography
A study testing CBCT radiation in people with Metal Artifacts, run by Cairo University at 1 site in Egypt.
Trial summary
The effect of metal artifacts reduction protocols and tube potential difference on the metallic artifacts in cone beam computed tomography Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Metal Artifacts
- What is being tested?
- CBCT radiation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Sep 2018to 10 Dec 2021
- 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
- bio models of a lower jaw Titanium implants Porcelain fused to metal crowns
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Metal Artifacts Reduction Protocols and Tube Potential Difference on Metal Artifacts in Cone Beam Computed
The effect of metal artifacts reduction protocols and tube potential difference on the metallic artifacts in cone beam computed tomography
Read the detailed description
Our study is a quantitative as well as a qualitative assessment of the metal artifacts in the CBCT images in a bio models with multiple adjacent dental implants and single isolated implants , while using different MAR protocols inherited in the CBCT soft ware , as well as change in the tube potential difference of the CBCT unit
- Conditions
- Metal Artifacts
- 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 | Experimental | Different kVp values of the CBCT machine 70, 80 ,90 kVp Receives: Radiation: CBCT radiation |
| MAR tool | Experimental | MAR option in the software off and on 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 and without the activation of the MAR tool of the CBCT soft ware, also change in the potential difference will be done with and without the activation of MAR tool
Measured: 1 month
Secondary outcomes (1)
Bone- implant interphase
Qualitative assessment if bone - implant interphase, will be either zero or 1 zero indicate that bone implant interphase cannot be assessed , one indicate that the bone implant interphase can be assessed
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2018
- Study start10 Sep 2018
- Primary completion30 Oct 2018
- Study completion10 Dec 2021 (estimated)
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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 2 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marina Salib, Cairo University
- Investigators
- Mushira M Dahba, Doctorate, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03726970
- Sponsor's protocol ID
- RAD
- Acronym
- DTA
- Status last verified
- Jan 2020
- First submitted
- 12 Oct 2018
- Last updated
- 23 Jan 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Metal Artifacts Reduction Protocols and Tube Potential Difference on Metal Artifacts in Cone Beam Computed
- ClinicalTrials.gov ID
- NCT03726970
- Acronym / sponsor ID
- DTA / RAD
- Conditions
- Metal Artifacts
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 2 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 10 Sep 2018 (actual)
- Primary completion
- 30 Oct 2018 (actual)
- Study completion
- 10 Dec 2021 (estimated)
- First posted
- 1 Nov 2018 (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 effect of metal artifacts reduction protocols and tube potential difference on the metallic artifacts in cone beam computed tomography
Detailed description
Our study is a quantitative as well as a qualitative assessment of the metal artifacts in the CBCT images in a bio models with multiple adjacent dental implants and single isolated implants , while using different MAR protocols inherited in the CBCT soft ware , as well as change in the tube potential difference of the CBCT unit
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tube Potential difference | Experimental | Radiation: CBCT radiationDifferent kVp values of the CBCT machine 70, 80 ,90 kVp |
| MAR tool | Experimental | Radiation: CBCT radiationMAR option in the software off and on |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- bio models of a lower jaw Titanium implants Porcelain fused to metal crowns
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 | MAR tool, Tube Potential difference |
Primary outcome
Dental implant linear measurement
Time frame: 1 month
The implant length and width in millimeters will be assessed in the presence of the artifacts with and without the activation of the MAR tool of the CBCT soft ware, also change in the potential difference will be done with and without the activation of MAR tool
1 secondary outcome
Bone- implant interphase
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2020.
- Individual participant dataSharing planned: Undecided
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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.
Mushira M Dahba, Doctorate 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?
A study testing CBCT radiation in people with Metal Artifacts, 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: status not confirmed, as of the sponsor's last update on 23 Jan 2020. 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?
Results are not available in the source record.
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: 1 month). 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 23 Jan 2020.