Accuracy of Surgical Guide in ImplantsNCT03389594
Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Sizes
A study testing Surgical guide in people with Accuracy of Surgical Guide in Implants, run by Cairo University at 1 site in Egypt.
Trial summary
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose. The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes . Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Accuracy of Surgical Guide in Implants
- What is being tested?
- Surgical guide
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jul 2017to 1 Apr 2018
- 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
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- partially edentulous patients seeking for dental implant
- Bucco-lingual width more than 6 mm
- Medically free patients
Who cannot join
- patients with thin ridges that may need augmentation
- patients with systematic diseases that may affect bone quality
- completely edentulous patients
- patients with limited mouth opening
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Cairo University
Cairo, 02
Info@dentistry.cu.edu.eg, 0223634965, Info@dentistry.cu.edu.eg
Mohammed Elhag
About this study
Official title: Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.
The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .
Read the detailed description
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.
The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm \& 0.2mm)
- Conditions
- Accuracy of Surgical Guide in Implants
- Being tested
- Surgical guide
- Keywords
- Surgical guide, Computer guided implantology, CBCT voxel size
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical guideOther
Surgical Guide for this group will designed from 0.4mm voxel size
| Study group | Role | What they receive |
|---|---|---|
| Surgical guide designed from voxel size 0.2mm | No intervention | Surgical guide will be designed based on CBCT voxel size 0.2mm |
| Surgical guide designed from voxel size 0.4m | Active comparator | Surgical guide will be designed based on CBCT voxel size 0.4 mm Receives: Other: Surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Angular deviation
Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm)
Measured: Immediate post operative
Linear deviation
Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm
Measured: Immediate post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jan 2018
- Study start1 Jul 2017
- Primary completion15 Mar 2018 (estimated)
- Study completion1 Apr 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Accuracy of Surgical Guide in ImplantsStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohammed Mohammed Ahmed Elhag, Cairo University
- Investigators
- Cairo university, Principal investigator, Cairo University, Faculty of dentistry
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03389594
- Sponsor's protocol ID
- ElhagCUImplant
- Status last verified
- Dec 2017
- First submitted
- 13 Dec 2017
- Last updated
- 3 Jan 2018
- Results posted
- No
- 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 3 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assesment of the Accuracy of Surgical Guide Designed From CBCT With Different Voxel Size in Computer Guided Implantology Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03389594
- Acronym / sponsor ID
- ElhagCUImplant
- Conditions
- Accuracy of Surgical Guide in Implants
- Keywords
- Surgical guide, Computer guided implantology, CBCT voxel size
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jul 2017 (actual)
- Primary completion
- 15 Mar 2018 (estimated)
- Study completion
- 1 Apr 2018 (estimated)
- First posted
- 3 Jan 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.
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.
The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes .
Detailed description
Accuracy Of CBCT affected by many factors. On of the most factors the affect the image quality is voxel size. Larger voxel size give a higher accuracy of the images but with higher radiation dose.
The study is to assist the accuracy of surgical guides designed from CBCT with different voxel sizes (voxel size 0.4mm \& 0.2mm)
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Surgical guide designed from voxel size 0.2mm | No intervention | –Surgical guide will be designed based on CBCT voxel size 0.2mm |
| Surgical guide designed from voxel size 0.4m | Active comparator | Other: Surgical guideSurgical guide will be designed based on CBCT voxel size 0.4 mm |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- partially edentulous patients seeking for dental implant
- Bucco-lingual width more than 6 mm
- Medically free patients
Key exclusion criteria (4 listed)
- patients with thin ridges that may need augmentation
- patients with systematic diseases that may affect bone quality
- completely edentulous patients
- patients with limited mouth opening
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 |
|---|---|---|
| Surgical guideSurgical Guide for this group will designed from 0.4mm voxel size | Other | Surgical guide designed from voxel size 0.4m |
Primary outcome
Angular deviation
Time frame: Immediate post operative
Evaluation of angular deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm)
Linear deviation
Time frame: Immediate post operative
Evaluation of linear deviation of virtual implant and actual implant positions according to voxel size difference (0.2 mm versus 0.4 mm
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2018.
- 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.
Cairo university principal investigator
Cairo University, Faculty of dentistry
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Surgical guide in people with Accuracy of Surgical Guide in Implants, 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 3 inclusion and 4 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 3 Jan 2018. 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?
Contact Mohamed Elhag, Bachelorie ((+202) 23634965 ext. 202, dentmail@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Angular deviation (time frame: Immediate post operative). The study lists 2 primary outcomes in all. 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 3 Jan 2018.