Completely EdentulousNCT07174791
Fully Versus Partially Guided Implants Placement: Measurement of Accuracy of Implant Position and Passivity of Superstructures.
A study testing cone beam computed tomography and photogrammetric scan using elite scanner (shining 3d) in people with Completely Edentulous and Implant Assesment, run by Mansoura University at 1 site in Egypt.
Trial summary
compare fully versus partially guided all on four implants placement immediately loaded by maxillary and mandibular screw retained overdentures: A radiographic and photogrammetric measurement of accuracy of implant position and passivity of superstructures. The measurements will be done as follows: 1. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Completely Edentulous, Implant Assesment
- What is being tested?
- cone beam computed tomography and photogrammetric scan using elite scanner (shining 3d)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Jan 2025to 15 Apr 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Completely healed residual alveolar ridges
- Angle's class I maxillo-mandibular relationship.
- Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
- Adequate bone height in the premaxilla area, and the anterior mandibular area. - This will be evaluated radiographically
Who cannot join
- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
- Local or general contraindication for surgical procedures.
- History of chemotherapy or radiation therapy to the head and neck area.
- Poor neuromuscular co-ordination.
- TMJ dysfunction and parafunctional habits
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Mansoura University, Faculty of Dentistry, mansoura, egypt
Al Mansurah, Mansoura
About this study
Official title: Fully Versus Partially Guided All on Four Implants Placement Immediately Loaded by Maxillary and Mandibular Screw Retained Prosthesis: A Radiographic and Photogrammetric Measurement of Accuracy of Implant Position and Passivity of Superstructures
compare fully versus partially guided all on four implants placement immediately loaded by maxillary and mandibular screw retained overdentures: A radiographic and photogrammetric measurement of accuracy of implant position and passivity of superstructures.
The measurements will be done as follows:
- Photogrammetric scan immediately after implant instalments to measure 3D accuracy of implant position and Passivity of super structure
- Cone beam X ray to measure the implant marginal bone height changes.
- Implant marginal soft tissue evaluations including pocket probing depth, plaque and gingival indices. Evaluation will be done immediately, one and two years after loading.
Read the detailed description
Sixteen healthy, fully edentate patients will be selected from the Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be informing about the protocol of the study and, they will sign a written consent. The study will be ethically approved according to the faculty of dentistry principles.
Sample size and study design A power analysis was made using a computer software (G* power) to detect the prober sample size based on the results of a previous study in which the authors found a significant difference in mesiodistal measurements between two groups (computer guided implant placement Vs conventional implant placement) using a similar study design. The sample size calculation yields a total of 32 implants (16 implants\ each group) using independent samples t-test. The following are details of sample size calculation: effect size= 0.904, Alpha (α)= .050. power (β)= .80
Patient selection i- Completely healed residual alveolar ridges ii- Angle's class I maxillo-mandibular relationship. iii- Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
iv- Adequate bone height in the premaxilla area, and the anterior mandibular area. This will be evaluated radiographically Exclusion criteria included (i) Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
(ii) Local or general contraindication for surgical procedures. (iii) History of chemotherapy or radiation therapy to the head and neck area. (iv) Poor neuromuscular co-ordination. (v) TMJ dysfunction and parafunctional habits
- Construction of conventional complete denture: Each patient will receive conventional complete denture and will be delivered and followed to adjust any post operative complains
- Construction of surgical guide by dual scan technique:
- According to the virtual 3D planning and surgical guide designing for implant instalment, patients will randomly be divided into two equal treatment groups as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment
- Photogrammetic scanning: For both groups based on the implant planning position and angulation a presurgical 3D printed model with digital analogue spaces will be constructed and scanned using photogrammetric device after connecting the multiunit digital analogues to the printed model in order to be compared to the model formed after implants placement in each group using photogrammetric device.
- Implant instalments:
- Flapless surgical protocol will be followed to install the maxillary and mandibular implants for both groups following all on 4 concepts.
- Post operative medication and home care will be followed for all patients.
- Construction of screw retained mandibular and maxillary overdentures
- Scan bodies will be screwed into the implant fixture and will be scanned intraorally
- The implant superstructure will be virtually planned and will be milled in (or 3D laser printed into cobalt chromium)
- Artificial teeth will be milled in according to balanced lingualized scheme and mandibular and maxillary screw retained will be fabricated and immediately delivered into the patient mouth within 2-3 days of implant instalment
- Methods of evaluation:
- Passivity of superstructure and 3-D accuracy of implant position will be measured immediately after loading by using photogrammetric device.
- Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading
- Evaluation peri-implant soft tissue changes in form of probing depth, and gingival and plaque indices will be measured immediately, one and two years of implant loading.
- Conditions
- Completely Edentulous, Implant Assesment
- Being tested
- cone beam computed tomography, photogrammetric scan using elite scanner (shining 3d)
- Keywords
- Guided surgery, semi-guided surgery, full arch implants, photogrammetry
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cone beam computed tomographyDevice
-Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading
photogrammetric scan using elite scanner (shining 3d)Device
implant placement accuracy will be evaluated using photogrammetric scan after implant insertion
| Study group | Role | What they receive |
|---|---|---|
| partially- guided (PG) implant instalment | Active comparator | partial guided allow control until the drill before the last one using universal drilling kit and the final osteotomy done with the system specific finishing drill after removal of the surgical guide. Receives: Device: cone beam computed tomography; Device: photogrammetric scan using elite scanner (shining 3d) |
| fully- guided (FG)implant instalment | Active comparator | Fully guided guides allow complete guidance to the drills tell the final one in addition to implants placement through the guide with control to the implant timing Receives: Device: cone beam computed tomography; Device: photogrammetric scan using elite scanner (shining 3d) |
What is being measured
The primary outcome is the main question the study is designed to answer.
accuracy of implant insertion
accuracy of implant position will be measured immediately after implant insertion by using photogrammetry scan for implants with multi-unit abutments intra-orally and on the model created from the planned implants and fitting surface of surgical guide, superimposition of both scans will be done using geomagic software to determine deviation in implant positions between both scans (Presurgical and post surgical) for both groups and calculated in fractions of millimeters, the value of deviation found in both semi-guided and fully-guided groups will be compared.
Measured: immediately after implant insertion
Secondary outcomes (2)
passive fit of final prosthesis
passivity of final prosthesis will be evaluated by radiography and gap distance will me measured on radiographic software in fractions of millimeters
Measured: immediately after final restoration insertion
Marginal bone loss
Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading
Measured: 24 months after prosthesis insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start15 Jan 2025
- Primary completion15 Apr 2025
- Study completion15 Apr 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Completely EdentulousStudies of the same condition, open and under way.
- More trials run by Mansoura 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
- Model description
- According to the virtual 3D planning and surgical guide designing for implant instalment, patients will be randomly divided into two equal treatment groups (4 patients for each) as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment both groups will be subjected to: 1. cone beam computed tomography to evaluate peri-implant alveolar bone loss 2. photogrammetric scan for evaluation of accuracy of implant placement and passivity of final prosthesis
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed shady, Mansoura University
- Investigators
- Mohamed Shady Mohamed Shady, MD, Principal investigator, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07174791
- Sponsor's protocol ID
- A03010024RP
- Status last verified
- Sep 2025
- First submitted
- 22 Jun 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Fully Versus Partially Guided All on Four Implants Placement Immediately Loaded by Maxillary and Mandibular Screw Retained Prosthesis: A Radiographic and Photogrammetric Measurement of Accuracy of Implant Position and Passivity of Superstructures
- ClinicalTrials.gov ID
- NCT07174791
- Acronym / sponsor ID
- A03010024RP
- Conditions
- Completely Edentulous, Implant Assesment
- Keywords
- Guided surgery, semi-guided surgery, full arch implants, photogrammetry
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- 15 Jan 2025 (actual)
- Primary completion
- 15 Apr 2025 (actual)
- Study completion
- 15 Apr 2026 (estimated)
- First posted
- 16 Sep 2025 (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.
compare fully versus partially guided all on four implants placement immediately loaded by maxillary and mandibular screw retained overdentures: A radiographic and photogrammetric measurement of accuracy of implant position and passivity of superstructures.
The measurements will be done as follows:
- Photogrammetric scan immediately after implant instalments to measure 3D accuracy of implant position and Passivity of super structure
- Cone beam X ray to measure the implant marginal bone height changes.
- Implant marginal soft tissue evaluations including pocket probing depth, plaque and gingival indices. Evaluation will be done immediately, one and two years after loading.
Detailed description
Sixteen healthy, fully edentate patients will be selected from the Prosthodontic Department, Faculty of Dentistry, Mansoura University. The patients will be informing about the protocol of the study and, they will sign a written consent. The study will be ethically approved according to the faculty of dentistry principles.
Sample size and study design A power analysis was made using a computer software (G* power) to detect the prober sample size based on the results of a previous study in which the authors found a significant difference in mesiodistal measurements between two groups (computer guided implant placement Vs conventional implant placement) using a similar study design. The sample size calculation yields a total of 32 implants (16 implants\ each group) using independent samples t-test. The following are details of sample size calculation: effect size= 0.904, Alpha (α)= .050. power (β)= .80
Patient selection i- Completely healed residual alveolar ridges ii- Angle's class I maxillo-mandibular relationship. iii- Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
iv- Adequate bone height in the premaxilla area, and the anterior mandibular area. This will be evaluated radiographically Exclusion criteria included (i) Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
(ii) Local or general contraindication for surgical procedures. (iii) History of chemotherapy or radiation therapy to the head and neck area. (iv) Poor neuromuscular co-ordination. (v) TMJ dysfunction and parafunctional habits
- Construction of conventional complete denture: Each patient will receive conventional complete denture and will be delivered and followed to adjust any post operative complains
- Construction of surgical guide by dual scan technique:
- According to the virtual 3D planning and surgical guide designing for implant instalment, patients will randomly be divided into two equal treatment groups as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment
- Photogrammetic scanning: For both groups based on the implant planning position and angulation a presurgical 3D printed model with digital analogue spaces will be constructed and scanned using photogrammetric device after connecting the multiunit digital analogues to the printed model in order to be compared to the model formed after implants placement in each group using photogrammetric device.
- Implant instalments:
- Flapless surgical protocol will be followed to install the maxillary and mandibular implants for both groups following all on 4 concepts.
- Post operative medication and home care will be followed for all patients.
- Construction of screw retained mandibular and maxillary overdentures
- Scan bodies will be screwed into the implant fixture and will be scanned intraorally
- The implant superstructure will be virtually planned and will be milled in (or 3D laser printed into cobalt chromium)
- Artificial teeth will be milled in according to balanced lingualized scheme and mandibular and maxillary screw retained will be fabricated and immediately delivered into the patient mouth within 2-3 days of implant instalment
- Methods of evaluation:
- Passivity of superstructure and 3-D accuracy of implant position will be measured immediately after loading by using photogrammetric device.
- Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading
- Evaluation peri-implant soft tissue changes in form of probing depth, and gingival and plaque indices will be measured immediately, one and two years of implant loading.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- According to the virtual 3D planning and surgical guide designing for implant instalment, patients will be randomly divided into two equal treatment groups (4 patients for each) as follows: Group (I): partially- guided (PG) implant instalment Group (II): fully- guided (FG)implant instalment both groups will be subjected to: 1. cone beam computed tomography to evaluate peri-implant alveolar bone loss 2. photogrammetric scan for evaluation of accuracy of implant placement and passivity of final prosthesis
| Arm | Type | Receives |
|---|---|---|
| partially- guided (PG) implant instalment | Active comparator | Device: cone beam computed tomography, Device: photogrammetric scan using elite scanner (shining 3d)partial guided allow control until the drill before the last one using universal drilling kit and the final osteotomy done with the system specific finishing drill after removal of the surgical guide. |
| fully- guided (FG)implant instalment | Active comparator | Device: cone beam computed tomography, Device: photogrammetric scan using elite scanner (shining 3d)Fully guided guides allow complete guidance to the drills tell the final one in addition to implants placement through the guide with control to the implant timing |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- Completely healed residual alveolar ridges
- Angle's class I maxillo-mandibular relationship.
- Sufficient mandibular and maxillary restorative spaces, at least 15mm evaluated by recording a tentative jaw relation.
- Adequate bone height in the premaxilla area, and the anterior mandibular area. - This will be evaluated radiographically
Key exclusion criteria (5 listed)
- Systemic disorders affecting bone (such as uncontrolled diabetes mellitus and osteoporosis).
- Local or general contraindication for surgical procedures.
- History of chemotherapy or radiation therapy to the head and neck area.
- Poor neuromuscular co-ordination.
- TMJ dysfunction and parafunctional habits
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 |
|---|---|---|
| cone beam computed tomography-Implant marginal bone height changes will be measured by cone beam radiograph after one and two years of loading | Device | fully- guided (FG)implant instalment, partially- guided (PG) implant instalment |
| photogrammetric scan using elite scanner (shining 3d)implant placement accuracy will be evaluated using photogrammetric scan after implant insertion | Device | fully- guided (FG)implant instalment, partially- guided (PG) implant instalment |
Primary outcome
accuracy of implant insertion
Time frame: immediately after implant insertion
accuracy of implant position will be measured immediately after implant insertion by using photogrammetry scan for implants with multi-unit abutments intra-orally and on the model created from the planned implants and fitting surface of surgical guide, superimposition of both scans will be done using geomagic software to determine deviation in implant positions between both scans (Presurgical and post surgical) for both groups and calculated in fractions of millimeters, the value of deviation found in both semi-guided and fully-guided groups will be compared.
2 secondary outcomes
passive fit of final prosthesis
Time frame: immediately after final restoration insertion
Marginal bone loss
Time frame: 24 months after prosthesis insertion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Mohamed Shady Mohamed Shady, MD principal investigator
Mansoura 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 cone beam computed tomography and photogrammetric scan using elite scanner (shining 3d) in people with Completely Edentulous and Implant Assesment, run by Mansoura 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 5 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: under way, not looking for participants, as of the sponsor's last update on 16 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of implant insertion (time frame: immediately after implant insertion). 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 16 Sep 2025.