Accuracy of Surgical Guide in Computer Guided ImplantologyNCT03367949
Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.
A study testing Surgical guide designed from Impression inversion with markers in people with Accuracy of Surgical Guide in Computer Guided Implantology, run by Cairo University at 1 site in Egypt.
Trial summary
Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide Impression inversion with markers technique avoids the dimension changes that may happen from pouring of… 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 Computer Guided Implantology
- What is being tested?
- Surgical guide designed from Impression inversion with markers
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 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 implants
- Patients with Bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
- Medically free patients.
- -
Who cannot join
- 1- Patients with thin ridges. 2- Patients with systemic disease that may affect bone quality. 3- Patients with poor oral hygiene and active periodontal diseases. 4- Anatomical situations requiring regenerative procedure. 5- Completely edentulous patient 6-Patient with limited mouth opening
- -
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry , Cairo university
Cairo
information desk, +20223634965, info@dentistry.cu.edu.eg
Abdullah A Elmasry
About this study
Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide
Impression inversion with markers technique avoids the dimension changes that may happen from pouring of the dental model cast. Also it saves time as no need for optical scan of the model cast and for scan appliance even in cases of multiple restoration. Adding markers to impression tray ensures an accurate merge even if the patient has restored dentition that may cause scatter during the CT/CBCT scan.
This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided Implantology.
- Being tested
- Surgical guide designed from Impression inversion with markers
- Keywords
- Surgical guide, impression inversion, stereolithographic surgical guides
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical guide designed from Impression inversion with markersOther
Rather than using optical scan of the cast , We will use impression inversion technique with VPS impression and adding CBCT Markers on the tray
| Study group | Role | What they receive |
|---|---|---|
| Accuracy of surgical guide from Model optical scan | No intervention | Not described |
| Accuracy of surgical guide from Impression inversion Technique | Active comparator | Not described Receives: Other: Surgical guide designed from Impression inversion with markers |
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 according to scanning protocol "optical scan of the model" Versus "impression inversion" using CBCT.
Measured: Immediate post operative
Secondary outcomes (1)
Evaluation of linear deviation of virtual implants and actual implant position according to scanning protocol " optical scan of the model" Versus " impression inversion " using CBCT
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 posted11 Dec 2017
- 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 Computer Guided ImplantologyStudies 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
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Abdullah Ahmed Elmasry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03367949
- Sponsor's protocol ID
- SGCBCTELMASRY
- Status last verified
- Dec 2017
- First submitted
- 5 Dec 2017
- Last updated
- 12 Dec 2017
- 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 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of the Accuracy of Surgical Guide Designed From Dental Model Optical Scan Versus Impression Inversion With Markers Techniques in Computer Guided Implantology. Randomized Clinical Trial.
- ClinicalTrials.gov ID
- NCT03367949
- Acronym / sponsor ID
- SGCBCTELMASRY
- Keywords
- Surgical guide, impression inversion, stereolithographic surgical guides
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 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
- 11 Dec 2017 (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.
Dental model cast accuracy can be affected by many variables as tray material, impression material and time elapsed before pouring the impression. All these factors would affect the accuracy of the surgical guide
Impression inversion with markers technique avoids the dimension changes that may happen from pouring of the dental model cast. Also it saves time as no need for optical scan of the model cast and for scan appliance even in cases of multiple restoration. Adding markers to impression tray ensures an accurate merge even if the patient has restored dentition that may cause scatter during the CT/CBCT scan.
This study will is for Assessment of the Accuracy of Surgical Guide designed from Dental Model Optical Scan versus Impression Inversion with Markers techniques in Computer Guided Implantology.
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 |
|---|---|---|
| Accuracy of surgical guide from Model optical scan | No intervention | – |
| Accuracy of surgical guide from Impression inversion Technique | Active comparator | Other: Surgical guide designed from Impression inversion with markers |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Partially Edentulous patients seeking for dental implants
- Patients with Bucco-lingual bone thickness more than 6 mm allowing flapless implant placement.
- Medically free patients.
- -
Key exclusion criteria (2 listed)
- 1- Patients with thin ridges. 2- Patients with systemic disease that may affect bone quality. 3- Patients with poor oral hygiene and active periodontal diseases. 4- Anatomical situations requiring regenerative procedure. 5- Completely edentulous patient 6-Patient 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 guide designed from Impression inversion with markersRather than using optical scan of the cast , We will use impression inversion technique with VPS impression and adding CBCT Markers on the tray | Other | Accuracy of surgical guide from Impression inversion Technique |
Primary outcome
Evaluation of angular deviation of virtual implants and actual implant position according to scanning protocol "optical scan of the model" Versus "impression inversion" using CBCT.
Time frame: Immediate post operative
1 secondary outcome
Evaluation of linear deviation of virtual implants and actual implant position according to scanning protocol " optical scan of the model" Versus " impression inversion " using CBCT
Time frame: Immediate post operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
- Individual participant dataSharing planned: Undecided
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.
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 designed from Impression inversion with markers in people with Accuracy of Surgical Guide in Computer Guided Implantology, 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 4 inclusion and 2 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 12 Dec 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. 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 according to scanning protocol "optical scan of the model" Versus "impression inversion" using CBCT. (time frame: Immediate post operative). 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 12 Dec 2017.