Computer-Assisted SurgeryNCT06001515
Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses
A study testing Dual scan protocol and triple scan protocol in people with Computer-Assisted Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
The study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement. Read more about this study
- Who is it for?
- Ages 50 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Computer-Assisted Surgery
- What is being tested?
- Dual scan protocol and triple scan protocol
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Nov 2023to Sep 2024
- 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 50 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.
Who cannot join
- The excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.
Trial locations and contacts
1 site in 1 country.
Ahmed Mostafa, BDS MSc MD contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry Ain Shams University
Cairo, 11361
Ahmed Abdelfattah, BSc, MSc, MD, 01111191337, ahmedmostafa@dent.asu.edu.eg
About this study
The study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement.
Read the detailed description
Twelve completely edentulous patients will be selected for full arch maxillary guided implants placement with immediately loaded restoration. The patients will make a complete oral and radiographic examination before inclusion in this study. All patients will receive maxillary and mandibular complete dentures that will be made in a conventional way. The patients will be randomly divided into two equal groups; group (I) and group (II). In both groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing the radiographic stent and another CBCT scan will be made for the radiographic stent alone. However, for patients in group II a face scan will be added to previous scans. For each patient in group I, the DICOM files will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is accomplished and the ideal surgical site and optimal implant dimensions will be selected. All the surgical guides will be planned to be totally limiting in this study. The immediate provisional restoration will be planned on the software according to the previously planned implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be subsequently sent as an STL file to a milling machine. For each patient in group II, the DICOM files and the STL files obtained from the face scans will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to define the interpupillary and midsagittal planes and to examine the tooth form and buccal corridor width with regard to the patient's smile line. Both files data will be superimposed and the planning for the implants sites, surgical guide and immediate restoration will be done as in group I. After implant insertion, CBCT scan will be made for each patient while wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and restoration will be made. Deviations between planned and placed implant will be measured in the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will be measured on a likert scale.
- Conditions
- Computer-Assisted Surgery
- Being tested
- Dual scan protocol, triple scan protocol
- Keywords
- guided implant placement- face scanning - edentulous maxilla
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual scan protocolDevice
one CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone
triple scan protocolDevice
3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol
| Study group | Role | What they receive |
|---|---|---|
| Dual scan protocol | Active comparator | Two CBCT scans will be made.One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone. Receives: Device: Dual scan protocol |
| Dual scan protocol +3D facial scan record | Experimental | 3D face scan record will be made plus Two CBCT scans. One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone. Receives: Device: triple scan protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
( Assessment of linear deviation
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral coronal deviation in millimeters.
Measured: 1day
( Assessment of linear deviation
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral apical deviation in millimeter.
Measured: 1day
( Assessment of angular deviation
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the angular deviation in degrees.
Measured: 1day
Secondary outcomes (1)
patient satisfaction
Accurate details recorded by using a 5 points likert scale for measuring the patient satisfaction by filling specific questionnaire: Oral Health Impact Profile 14 questions ( OHIP-14) and taking the answer of each question on a 5 point likert scale with 0 for the worst score and 5 for the best one
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start1 Nov 2023
- Primary completionApr 2024 (estimated)
- Study completionSep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Computer-Assisted SurgeryStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Model description
- one experimental group and one active comparator group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dina Abdelmoez, Ain Shams University
- Investigators
- Noha H Nawar, BDS MSc MD, Study director, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06001515
- Sponsor's protocol ID
- FDASU-RecID012328
- Status last verified
- Oct 2023
- First submitted
- 14 Aug 2023
- Last updated
- 13 Nov 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Face Scanning on Accuracy of Dental Implant Placement in Fixed Implant Supported Maxillary Prostheses
- ClinicalTrials.gov ID
- NCT06001515
- Acronym / sponsor ID
- FDASU-RecID012328
- Conditions
- Computer-Assisted Surgery
- Keywords
- guided implant placement- face scanning - edentulous maxilla
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Sep 2024 (estimated)
- First posted
- 21 Aug 2023 (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.
The study will compare the accuracy of surgical guides fabricated by two different scanning protocols; facially driven scanning versus dual scanning protocol regarding the deviation of implant placement.
Detailed description
Twelve completely edentulous patients will be selected for full arch maxillary guided implants placement with immediately loaded restoration. The patients will make a complete oral and radiographic examination before inclusion in this study. All patients will receive maxillary and mandibular complete dentures that will be made in a conventional way. The patients will be randomly divided into two equal groups; group (I) and group (II). In both groups two CBCT scans will be made. A CBCT scan will be made for each patient while wearing the radiographic stent and another CBCT scan will be made for the radiographic stent alone. However, for patients in group II a face scan will be added to previous scans. For each patient in group I, the DICOM files will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH), fusion of the scan prosthesis via the markers is accomplished and the ideal surgical site and optimal implant dimensions will be selected. All the surgical guides will be planned to be totally limiting in this study. The immediate provisional restoration will be planned on the software according to the previously planned implants sites. The surgical guide will be 3D printed. The approved tooth arrangement will be subsequently sent as an STL file to a milling machine. For each patient in group II, the DICOM files and the STL files obtained from the face scans will be exported to Blue Sky implant designing software (Langenhagener, Mdi Europa GmbH). The facial scan will be used to define the interpupillary and midsagittal planes and to examine the tooth form and buccal corridor width with regard to the patient's smile line. Both files data will be superimposed and the planning for the implants sites, surgical guide and immediate restoration will be done as in group I. After implant insertion, CBCT scan will be made for each patient while wearing the scan appliance. Superimposition of CBCT scans pre and post implant insertion and restoration will be made. Deviations between planned and placed implant will be measured in the lateral apical, lateral coronal and angular aspects. Also, the patient satisfaction will be measured on a likert scale.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- one experimental group and one active comparator group
| Arm | Type | Receives |
|---|---|---|
| Dual scan protocol | Active comparator | Device: Dual scan protocolTwo CBCT scans will be made.One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone. |
| Dual scan protocol +3D facial scan record | Experimental | Device: triple scan protocol3D face scan record will be made plus Two CBCT scans. One while the patient wearing the radiographic stent and another CBCT for the radiographic stent alone. |
Who may qualify
- Ages
- 50 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- The inclusion criteria will be completely edentulous patients, non-smokers, 50-70 years in age, have Good oral hygiene and motivation.
Key exclusion criteria (1 listed)
- The excluded patients will include patients with major systemic diseases that may affect osseointegration as uncontrolled diabetes mellitus, the need for extensive bone grafting in planned implant site, pregnancy, patients under bisphosphonate treatment, and limited mouth-opening for executing the guided implant surgery.
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 |
|---|---|---|
| Dual scan protocolone CBCT scan for the patient while wearing the scan appliance and another scan for the appliance alone | Device | Dual scan protocol |
| triple scan protocol3D facial Scanning for the patients while wearing their dentures in addition to the dual scan protocol | Device | Dual scan protocol +3D facial scan record |
Primary outcome
( Assessment of linear deviation
Time frame: 1day
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral coronal deviation in millimeters.
( Assessment of linear deviation
Time frame: 1day
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the lateral apical deviation in millimeter.
( Assessment of angular deviation
Time frame: 1day
Accurate details recorded by superimposition of CBCTs using the blue sky software program by measuring the angular deviation in degrees.
1 secondary outcome
patient satisfaction
Time frame: 1 day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
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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.
Ahmed Mostafa, BDS MSc MD contact
Noha H Nawar, BDS MSc MD study director
Ain Shams University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Dual scan protocol and triple scan protocol in people with Computer-Assisted Surgery, run by Ain Shams 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 1 inclusion and 1 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 13 Nov 2023. 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 Dina Abd Elmoez, BDS MSc (01030762236, Dodo1992am@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
( Assessment of linear deviation (time frame: 1day). The study lists 3 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 13 Nov 2023.