Guided SurgeryNCT03025243
The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides
A study testing computer aided surgical guide in people with Guided Surgery, run by Cairo University.
Trial summary
The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Guided Surgery
- What is being tested?
- computer aided surgical guide
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to Jan 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- patients partially or totally edentulous arches .
- patients with Bucco-lingual bone thickness >6 mm allowing flapless implant placement
- patients free from any systemic diseases that may affect bone quality e.g diabetes .
Who cannot join
- patients with thin ridges.
- patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Anatomical situations requiring regenerative procedure.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides : A Randomized Clinical Trial
The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide
Read the detailed description
Computer aided surgical guide has many variables that affect its accuracy , in this study one variable is considered that may affect the accuracy of surgical guide which is printing of layer thickness of surgical guide whether 50 micron or 100 micron.
computer aided surgical guide is constructed by imaging the patient pre-operative cone beam CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky Bio ) and optical scanning of patient casts , afterword superimposition of the virtual implants on the scanned casts to design the surgical guide and printing on 3D printer ( Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same apparatus and setting as pre-operative scan .
Finally, the pre-operative and post operative scans were then overlapped to measure linear and angular deviation of the virtually planned and actual implants position.
- Conditions
- Guided Surgery
- Being tested
- computer aided surgical guide
- Keywords
- computer aided design , dental implants , accuracy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
computer aided surgical guideDevice
Also called surgical guide
comparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT
| Study group | Role | What they receive |
|---|---|---|
| 50 micron | Experimental | surgical guide constructed with 3D printing with printing layer thickness 50 micron Receives: Device: computer aided surgical guide |
| 100 micron | Active comparator | surgical guide constructed with 3D printing with printing layer thickness 100 micron Receives: Device: computer aided surgical guide |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of surgical guide
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jan 2017 (estimated)
- Study startJan 2017
- Primary completionJan 2018 (estimated)
- Study completionJan 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Guided SurgeryStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Mohamed Ahmed Hanafy, Cairo University
- Investigators
- Mahmoud El far, phd, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03025243
- Sponsor's protocol ID
- CEBC-CU-2017-01-08
- Status last verified
- Jan 2017
- First submitted
- 16 Jan 2017
- Last updated
- 19 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Printing Layer Thickness on the Accuracy of Computer Aided Surgical Guides : A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03025243
- Acronym / sponsor ID
- CEBC-CU-2017-01-08
- Conditions
- Guided Surgery
- Keywords
- computer aided design , dental implants , accuracy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Jan 2017
- Primary completion
- Jan 2018 (estimated)
- Study completion
- Jan 2018 (estimated)
- First posted
- 19 Jan 2017 (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.
The purpose of this study is to evaluate the effect of printing layer thickness on accuracy of computer aided surgical guide
Detailed description
Computer aided surgical guide has many variables that affect its accuracy , in this study one variable is considered that may affect the accuracy of surgical guide which is printing of layer thickness of surgical guide whether 50 micron or 100 micron.
computer aided surgical guide is constructed by imaging the patient pre-operative cone beam CT wearing scan appliance , then virtual implant placement on special soft ware ( Blue sky Bio ) and optical scanning of patient casts , afterword superimposition of the virtual implants on the scanned casts to design the surgical guide and printing on 3D printer ( Zenith 3D printer , Dentis , Korea ) with printing layer thickness 50 micron in first group and 100 micron in second group . Fixation of surgical guide in patient mouth and drilling of implant osteotomy through the guiding sleeves , post-operative Cone Beam CT with the same apparatus and setting as pre-operative scan .
Finally, the pre-operative and post operative scans were then overlapped to measure linear and angular deviation of the virtually planned and actual implants position.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 50 micron | Experimental | Device: computer aided surgical guidesurgical guide constructed with 3D printing with printing layer thickness 50 micron |
| 100 micron | Active comparator | Device: computer aided surgical guidesurgical guide constructed with 3D printing with printing layer thickness 100 micron |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- patients partially or totally edentulous arches .
- patients with Bucco-lingual bone thickness >6 mm allowing flapless implant placement
- patients free from any systemic diseases that may affect bone quality e.g diabetes .
Key exclusion criteria (4 listed)
- patients with thin ridges.
- patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Anatomical situations requiring regenerative procedure.
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 |
|---|---|---|
| computer aided surgical guideAlso: surgical guidecomparing accuracy of surgical guide of printing layer thickness of 50 micron and 100 micron by superimposition of pre-operative and post-operative CBCT | Device | 100 micron, 50 micron |
Primary outcome
accuracy of surgical guide
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Jan 2017.
- 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.
Mahmoud El far, phd study director
Cairo University
Questions about this trial
What is this clinical trial studying?
A study testing computer aided surgical guide in people with Guided Surgery, run by Cairo 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 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 19 Jan 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Amr M Hanafy, master (01111228022, amrhanafy201055@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of surgical guide (time frame: 6 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 19 Jan 2017.