Computer Guided ImplantNCT03730506
Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology:
A study testing Intra oral scanner in people with Computer Guided Implant, run by Cairo University.
Trial summary
Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology: Randomized Clinical Trial. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Computer Guided Implant
- What is being tested?
- Intra oral scanner
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- No sites listed yet
- Study dates
- Nov 2018to Jul 2020
- 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 patient.
- Patients with bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
Who cannot join
- Completely edentulous patient or Free end saddle edentulous area.
- Patients needing graft or sinus lifting with implant placement.
- Patients with thin ridges.
- Patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
- Patient with limited mouth opening
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology: Randomized Clinical Trial
Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology:
Randomized Clinical Trial.
Read the detailed description
Research question:
In computer guided Implantology, are surgical stents designed from scan of dental model by CBCT and from digital impression as accurate as surgical stents designed from desktop scanner?
Statement of the problem:
The role digital dentistry is improved in computer guided implantology especially with development of computer guided implant software, desktop scanner and intra oral scanner development and CBCT machines.
Intra-oral scanner, desktop scanner and CBCT scanner can be used in creation of 3D digital model that can be used with computer guided implant in fabrication of the surgical stent.
And the question, is the accuracy of surgical guide will be affected when designed by one of these different modalities?
Rationale for conducting the research:
Digital 3D dentoginival details are very important in computer guided implantology and designing of surgical stent.nowadays there are many methods to obtain this soft tissue replica as CBCT,desktop scanner and intra oral scanner.this study is conducted to asses the effect of different method of soft tissue digitization on the accuracy of surgical template used in computer guided implantology.
- Conditions
- Computer Guided Implant
- Being tested
- Intra oral scanner
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intra oral scannerDevice
Also called CBCT, desktop scanner
computer guided implant
| Study group | Role | What they receive |
|---|---|---|
| CBCT | Experimental | Not described Receives: Device: Intra oral scanner |
| IOS | Experimental | Not described Receives: Device: Intra oral scanner |
| desktop scanner | Active comparator | Not described Receives: Device: Intra oral scanner |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees
Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees to assess the accuracy of surgical guide
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2018
- Study startNov 2018 (estimated)
- Primary completionJul 2019 (estimated)
- Study completionJul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer Guided ImplantStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 9 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr taha Adu el wafa, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03730506
- Sponsor's protocol ID
- RAD2:7:1
- Status last verified
- Nov 2018
- First submitted
- 22 Oct 2018
- Last updated
- 5 Nov 2018
- 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 5 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Surgical Guide Designed From Digital Impression, Dental Model Scanning Using CBCT and Desktop Scanner in Computer Guided Implantology: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03730506
- Acronym / sponsor ID
- RAD2:7:1
- Conditions
- Computer Guided Implant
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 9 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- Nov 2018 (estimated)
- Primary completion
- Jul 2019 (estimated)
- Study completion
- Jul 2020 (estimated)
- First posted
- 5 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.
Assessment of the Accuracy of Surgical Guide Designed from Digital Impression, Dental Model Scanning using CBCT and Desktop Scanner in Computer Guided Implantology:
Randomized Clinical Trial.
Detailed description
Research question:
In computer guided Implantology, are surgical stents designed from scan of dental model by CBCT and from digital impression as accurate as surgical stents designed from desktop scanner?
Statement of the problem:
The role digital dentistry is improved in computer guided implantology especially with development of computer guided implant software, desktop scanner and intra oral scanner development and CBCT machines.
Intra-oral scanner, desktop scanner and CBCT scanner can be used in creation of 3D digital model that can be used with computer guided implant in fabrication of the surgical stent.
And the question, is the accuracy of surgical guide will be affected when designed by one of these different modalities?
Rationale for conducting the research:
Digital 3D dentoginival details are very important in computer guided implantology and designing of surgical stent.nowadays there are many methods to obtain this soft tissue replica as CBCT,desktop scanner and intra oral scanner.this study is conducted to asses the effect of different method of soft tissue digitization on the accuracy of surgical template used in computer guided implantology.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| CBCT | Experimental | Device: Intra oral scanner |
| IOS | Experimental | Device: Intra oral scanner |
| desktop scanner | Active comparator | Device: Intra oral scanner |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- partially edentulous patient.
- Patients with bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
Key exclusion criteria (6 listed)
- Completely edentulous patient or Free end saddle edentulous area.
- Patients needing graft or sinus lifting with implant placement.
- Patients with thin ridges.
- Patients with systemic disease that may affect bone quality.
- Patients with poor oral hygiene and active periodontal diseases.
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 |
|---|---|---|
| Intra oral scannerAlso: CBCT, desktop scannercomputer guided implant | Device | CBCT, IOS, desktop scanner |
Primary outcome
Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees
Time frame: one year
Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees to assess the accuracy of surgical guide
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2018.
- Individual participant dataSharing planned: Undecided
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Accuracy of Immediate Implant Placement
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Accuracy of AI Assisted Surgical Guide (AISG)
Accuracy of AI App, Accuracy of AI Assisted Surgical Guides
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Intra oral scanner in people with Computer Guided Implant, 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 2 inclusion and 6 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 5 Nov 2018. 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 taha (01068904154, amrtaha@debtistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of angular deviation of virtual implants and actual implant position by 3rd party software in degrees (time frame: one year). 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 5 Nov 2018.