Dental ImplantationNCT03321162
Accuracy of Guided Implant Placement Using Double Versus Triple Scan Protocol in Completely Edentulous Patients
An observational study of Dental Implantation, run by Cairo University.
Trial summary
16 implant placement by surgical guide using double scan protocol versus triple scan protocol to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) . Read more about this study
- Who is it for?
- Ages 30 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Implantation
- What is being tested?
- scan protocol
- How many people
- 16 participants
- Where
- No sites listed yet
- Study dates
- 20 Nov 2017to Feb 2018
- Phase
- Observational
- 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 30 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients receiving dental implants in both arches by guided surgery using double versus triple scan protocol .
Who may be able to join
- patients 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: Accuracy of Guided Implant Placement Using Double Versus Triple Scan Protocol in Completely Edentulous Patients : Randomized Clinical Trial
16 implant placement by surgical guide using double scan protocol versus triple scan protocol to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
Read the detailed description
In this study we discuss linear and angular deviation of actual implant position using planning protocol C1(double scan technique) or C2 (triple scan technique) in completely edentulous patient .
Both protocols C1(double scan technique) and C2 (triple scan technique) indicated in completely edentulous patient and require C.T scan for patient wearing scan appliance .
In C1(double scan technique) , after CT scan for patient wearing scan appliance , two optical scan for the model with and without scan appliance.
In C2 (triple scan technique) , after CT scan for patient wearing scan appliance , CT scan for scan appliance alone .
Teeth positions in both protocols were identified by radio-opaque scan appliance .
16 implant placement by surgical guide using double scan protocol versus triple scan protocol ( two groups - 8 implants in each group ) to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
- Conditions
- Dental Implantation
- Being tested
- scan protocol
- Keywords
- surgical guide , double scan , triple scan protocol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
scan protocolDiagnostic test
Scanning strategy is based on multiple scans. Essentially one CT scan of the patient (usually with a scan appliance). Another CT scan of the model or scan appliance may be required (double scan technique). Such a second CT scan can be replaced by optical scanning of the model and scan appliance (triple scan technique).
| Study group | Role | What they receive |
|---|---|---|
| double scan protocol | In C1(double scan technique) , after CT scan for patient wearing scan appliance , two optical scan for the model with and without scan appliance. | |
| triple scan protocol | In C2 (triple scan technique) , after CT scan for patient wearing scan appliance , CT scan for scan appliance alone . Receives: Diagnostic Test: scan protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of angular deviation between planned implants in surgical guide and actual implant position in completely edentulous patients .
Evaluation of angular deviation between planned implants in surgical guide and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
Measured: immediate post operative
Secondary outcomes (1)
Evaluation of linear deviation between planned implants in surgical guide and actual implant position in completely edentulous patients
Evaluation of linear deviation between planned implants in surgical guide and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
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 posted25 Oct 2017
- Study start20 Nov 2017 (estimated)
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental ImplantationStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa mohamed el maghraby, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03321162
- Sponsor's protocol ID
- Cebc.cu. cairo university
- Status last verified
- Nov 2017
- First submitted
- 22 Oct 2017
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Guided Implant Placement Using Double Versus Triple Scan Protocol in Completely Edentulous Patients : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03321162
- Acronym / sponsor ID
- Cebc.cu. cairo university
- Conditions
- Dental Implantation
- Keywords
- surgical guide , double scan , triple scan protocol
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 20 Nov 2017 (estimated)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 25 Oct 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.
16 implant placement by surgical guide using double scan protocol versus triple scan protocol to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
Detailed description
In this study we discuss linear and angular deviation of actual implant position using planning protocol C1(double scan technique) or C2 (triple scan technique) in completely edentulous patient .
Both protocols C1(double scan technique) and C2 (triple scan technique) indicated in completely edentulous patient and require C.T scan for patient wearing scan appliance .
In C1(double scan technique) , after CT scan for patient wearing scan appliance , two optical scan for the model with and without scan appliance.
In C2 (triple scan technique) , after CT scan for patient wearing scan appliance , CT scan for scan appliance alone .
Teeth positions in both protocols were identified by radio-opaque scan appliance .
16 implant placement by surgical guide using double scan protocol versus triple scan protocol ( two groups - 8 implants in each group ) to Evaluate angular and linear deviation of virtual implants and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
Study design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| double scan protocol | – | –In C1(double scan technique) , after CT scan for patient wearing scan appliance , two optical scan for the model with and without scan appliance. |
| triple scan protocol | – | Diagnostic Test: scan protocolIn C2 (triple scan technique) , after CT scan for patient wearing scan appliance , CT scan for scan appliance alone . |
Who may qualify
- Ages
- 30 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients receiving dental implants in both arches by guided surgery using double versus triple scan protocol .
Key inclusion criteria (3 listed)
- patients 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 |
|---|---|---|
| scan protocolScanning strategy is based on multiple scans. Essentially one CT scan of the patient (usually with a scan appliance). Another CT scan of the model or scan appliance may be required (double scan technique). Such a second CT scan can be replaced by optical scanning of the model and scan appliance (triple scan technique). | Diagnostic test | triple scan protocol |
Primary outcome
Evaluation of angular deviation between planned implants in surgical guide and actual implant position in completely edentulous patients .
Time frame: immediate post operative
Evaluation of angular deviation between planned implants in surgical guide and actual implant position in completely edentulous patients according to scanning protocol C1(double scan technique) and C2 (triple scan technique) .
1 secondary outcome
Evaluation of linear deviation between planned implants in surgical guide and actual implant position in completely edentulous patients
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 7 Nov 2017.
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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?
An observational study of Dental Implantation, 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 7 Nov 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 Mostafa M El- Maghraby (00201020212115, maghraby_dentist@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of angular deviation between planned implants in surgical guide and actual implant position in completely edentulous patients . (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 7 Nov 2017.