Full Arch Implant RehabilitationNCT07740265
Effect of Scanning Techniques on Accuracy of Mandibular Fixed Detachable Prostheses
A study testing Splinted Scan Body with composite, IO Connect Scanning Technique and Auxiliary Geometric Device Scanning Technique in people with Full Arch Implant Rehabilitation, run by Tanta University at 1 site in Egypt.
Trial summary
This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Read more about this study
- Who is it for?
- Ages 40 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Full Arch Implant Rehabilitation
- What is being tested?
- Splinted Scan Body with composite, IO Connect Scanning Technique and Auxiliary Geometric Device Scanning Technique
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteEgypt
- Study dates
- 8 Jun 2026to 1 Jul 2027
- 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 40 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Completely edentulous patients with age between 40-60 years.
- Adequate bone height to fulfill the criteria for implant placement.
- Patients should have a class I Angle's classification.
Who cannot join
- .Insufficient vertical inter-arch space to accommodate the restorative components.
- .Presence of psychiatric or neurological conditions. .Any systemic diseases that may affect implant bone osteointegration.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc contact
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Dentistry, Tanta University
Tanta, Gharbia Governorate, 31527
Mostafa Hamed Mostafa Abd El-Hameed, +201090461713, mostafa_hamed@dent.tanta.edu.eg
Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc
About this study
Official title: Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).
This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.
Read the detailed description
This prospective crossover clinical trial is designed to evaluate and compare the accuracy and passive fit of three different intraoral scanning techniques used for the fabrication of mandibular implant-supported fixed detachable prostheses in completely edentulous patients.
The study will include completely edentulous participants rehabilitated with four osseointegrated implants placed in the mandibular arch. Each participant will undergo digital implant impression procedures using three different scanning .
The three scanning techniques being compared are:
- Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning.
- Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system.
- Auxiliary Geometric Devices: Digital impressions will be acquired using 3D-printed auxiliary geometric devices attached to the scan bodies to provide additional geometric reference landmarks during scanning.
Digital datasets generated from each scanning technique will be analyzed and compared. Verification jigs will be fabricated using CAD/CAM technology and clinically evaluated.
The primary outcomes of the study are scanning accuracy, assessed by measuring linear deviation (µm) and angular deviation (degrees) between implant positions obtained from the different scanning techniques, and three-dimensional surface deviation analysis, assessed through root mean square (RMS) values and median surface deviation obtained from STL file superimposition.
The secondary outcome is passive fit , which will be evaluated using the Sheffield one-screw test and intraoral periapical radiographic assessment.
The findings of this study will help identify the scanning technique that provides the highest accuracy and best passive fit for mandibular implant-supported fixed detachable prostheses and may contribute to improving digital workflows in complete-arch implant rehabilitation.
- Conditions
- Full Arch Implant Rehabilitation
- Being tested
- Splinted Scan Body with composite, IO Connect Scanning Technique, Auxiliary Geometric Device Scanning Technique
- Keywords
- Intraoral Scanner, Digital impression, Passive fit, Auxiliary Geometric Device, Fixed Detachable Prosthesis, Implant Scan Body, Full-arch implant, horizontal scan body
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Splinted Scan Body with compositeDevice
A full-arch digital implant impression will be obtained using implant scan bodies splinted with composite resin prior to scanning. The splinting procedure will provide enhanced scan body stability and will be used to minimize positional discrepancies during digital impression acquisition.
IO Connect Scanning TechniqueDevice
A full-arch digital implant impression will be obtained using horizontal non-calibrated scan bodies (IO Connect). The horizontal scan body design will facilitate implant position recognition, digital alignment, and accurate transfer of implant coordinates throughout the digital impression procedure.
Auxiliary Geometric Device Scanning TechniqueDevice
A full-arch digital implant impression will be obtained using 3D-printed auxiliary geometric devices attached to implant scan bodies. These auxiliary devices will provide additional geometric reference landmarks to improve stitching accuracy, reduce cumulative scanning errors, and enhance complete-arch digital impression accuracy.
| Study group | Role | What they receive |
|---|---|---|
| Splinted Scan Bodies with composite | Experimental | Participants will undergo full-arch digital implant scanning using implant scan bodies splinted with composite resin. The splinting procedure is intended to improve the stability of scan bodies and reduce positional discrepancies during digital impression acquisition. Receives: Device: Splinted Scan Body with composite |
| horizontal non-calibrated scan bodies | Experimental | Participants will undergo full-arch digital implant scanning using horizontal non-calibrated scan bodies (IO Connect). This technique utilizes a horizontal scan body design to facilitate implant position recognition, digital alignment, and complete-arch digital impression acquisition. Receives: Device: IO Connect Scanning Technique |
| Auxiliary Geometric Device Scanning | Experimental | Participants will undergo full-arch digital implant scanning using 3D-printed auxiliary geometric devices attached to implant scan bodies. The auxiliary devices provide additional geometric reference landmarks intended to improve scanning accuracy and reduce stitching errors during complete-arch digital impressions. Receives: Device: Auxiliary Geometric Device Scanning Technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Implant linear and angular deviation
The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other
Measured: Immediately after completion of digital scanning day 0
Three-Dimensional part comparison
Three-dimensional surface deviation will be evaluated by uploading all STL files to dedicated comparison software. Digital superimposition will be performed to calculate the median surface deviation and root mean square (RMS) values between the datasets, providing a quantitative assessment of surface discrepancies among the three scanning techniques.
Measured: Immediately after completion of digital scanning day 0
Secondary outcomes (1)
fit of verification jig
Passive fit will be evaluated clinically using the Sheffield one-screw test and confirmed by intraoral periapical radiographs.
Measured: Within 1 hour of fabrication and intraoral placement of the verification jig
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2026
- Study start8 Jun 2026
- Primary completion1 Apr 2027 (estimated)
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Full Arch Implant RehabilitationStudies of the same condition, open and under way.
- More trials run by Tanta 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
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Each participant will undergo all three intraoral scanning techniques in a randomized sequence. The three scanning techniques include splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices. The crossover design allows within-subject comparison of scanning accuracy and passive fit while minimizing inter-participant variability.
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Hamed Mostafa Abd El-Hameed, Tanta University
- Investigators
- Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc, Principal investigator, Faculty of Dentistry, Tanta University, Egypt
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07740265
- Sponsor's protocol ID
- RP-11-25-3482
- Status last verified
- Sep 2026
- First submitted
- 28 Jul 2026
- Last updated
- 2 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- 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 2 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).
- ClinicalTrials.gov ID
- NCT07740265
- Acronym / sponsor ID
- RP-11-25-3482
- Conditions
- Full Arch Implant Rehabilitation
- Keywords
- Intraoral Scanner, Digital impression, Passive fit, Auxiliary Geometric Device, Fixed Detachable Prosthesis, Implant Scan Body, Full-arch implant, horizontal scan body
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 8 Jun 2026 (actual)
- Primary completion
- 1 Apr 2027 (estimated)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 31 Jul 2026 (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.
This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.
Detailed description
This prospective crossover clinical trial is designed to evaluate and compare the accuracy and passive fit of three different intraoral scanning techniques used for the fabrication of mandibular implant-supported fixed detachable prostheses in completely edentulous patients.
The study will include completely edentulous participants rehabilitated with four osseointegrated implants placed in the mandibular arch. Each participant will undergo digital implant impression procedures using three different scanning .
The three scanning techniques being compared are:
- Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning.
- Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system.
- Auxiliary Geometric Devices: Digital impressions will be acquired using 3D-printed auxiliary geometric devices attached to the scan bodies to provide additional geometric reference landmarks during scanning.
Digital datasets generated from each scanning technique will be analyzed and compared. Verification jigs will be fabricated using CAD/CAM technology and clinically evaluated.
The primary outcomes of the study are scanning accuracy, assessed by measuring linear deviation (µm) and angular deviation (degrees) between implant positions obtained from the different scanning techniques, and three-dimensional surface deviation analysis, assessed through root mean square (RMS) values and median surface deviation obtained from STL file superimposition.
The secondary outcome is passive fit , which will be evaluated using the Sheffield one-screw test and intraoral periapical radiographic assessment.
The findings of this study will help identify the scanning technique that provides the highest accuracy and best passive fit for mandibular implant-supported fixed detachable prostheses and may contribute to improving digital workflows in complete-arch implant rehabilitation.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Each participant will undergo all three intraoral scanning techniques in a randomized sequence. The three scanning techniques include splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices. The crossover design allows within-subject comparison of scanning accuracy and passive fit while minimizing inter-participant variability.
| Arm | Type | Receives |
|---|---|---|
| Splinted Scan Bodies with composite | Experimental | Device: Splinted Scan Body with compositeParticipants will undergo full-arch digital implant scanning using implant scan bodies splinted with composite resin. The splinting procedure is intended to improve the stability of scan bodies and reduce positional discrepancies during digital impression acquisition. |
| horizontal non-calibrated scan bodies | Experimental | Device: IO Connect Scanning TechniqueParticipants will undergo full-arch digital implant scanning using horizontal non-calibrated scan bodies (IO Connect). This technique utilizes a horizontal scan body design to facilitate implant position recognition, digital alignment, and complete-arch digital impression acquisition. |
| Auxiliary Geometric Device Scanning | Experimental | Device: Auxiliary Geometric Device Scanning TechniqueParticipants will undergo full-arch digital implant scanning using 3D-printed auxiliary geometric devices attached to implant scan bodies. The auxiliary devices provide additional geometric reference landmarks intended to improve scanning accuracy and reduce stitching errors during complete-arch digital impressions. |
Who may qualify
- Ages
- 40 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Completely edentulous patients with age between 40-60 years.
- Adequate bone height to fulfill the criteria for implant placement.
- Patients should have a class I Angle's classification.
Key exclusion criteria (2 listed)
- .Insufficient vertical inter-arch space to accommodate the restorative components.
- .Presence of psychiatric or neurological conditions. .Any systemic diseases that may affect implant bone osteointegration.
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 |
|---|---|---|
| Splinted Scan Body with compositeA full-arch digital implant impression will be obtained using implant scan bodies splinted with composite resin prior to scanning. The splinting procedure will provide enhanced scan body stability and will be used to minimize positional discrepancies during digital impression acquisition. | Device | Splinted Scan Bodies with composite |
| IO Connect Scanning TechniqueA full-arch digital implant impression will be obtained using horizontal non-calibrated scan bodies (IO Connect). The horizontal scan body design will facilitate implant position recognition, digital alignment, and accurate transfer of implant coordinates throughout the digital impression procedure. | Device | horizontal non-calibrated scan bodies |
| Auxiliary Geometric Device Scanning TechniqueA full-arch digital implant impression will be obtained using 3D-printed auxiliary geometric devices attached to implant scan bodies. These auxiliary devices will provide additional geometric reference landmarks to improve stitching accuracy, reduce cumulative scanning errors, and enhance complete-arch digital impression accuracy. | Device | Auxiliary Geometric Device Scanning |
Primary outcome
Implant linear and angular deviation
Time frame: Immediately after completion of digital scanning day 0
The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other
Three-Dimensional part comparison
Time frame: Immediately after completion of digital scanning day 0
Three-dimensional surface deviation will be evaluated by uploading all STL files to dedicated comparison software. Digital superimposition will be performed to calculate the median surface deviation and root mean square (RMS) values between the datasets, providing a quantitative assessment of surface discrepancies among the three scanning techniques.
1 secondary outcome
fit of verification jig
Time frame: Within 1 hour of fabrication and intraoral placement of the verification jig
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 2 Oct 2026.
- Individual participant dataSharing planned: No
Related trials for Full Arch Implant Rehabilitation
Recruiting
Evaluating the Accuracy of Dynamic Navigation in Implant Surgery for Full Arch Prosthesis
Accuracy of Dynamic Navigation System in Implant Placement for Full Arch Prosthesis Rehabilitation
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.
Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc contact
Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc principal investigator
Faculty of Dentistry, Tanta University, Egypt
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Splinted Scan Body with composite, IO Connect Scanning Technique and Auxiliary Geometric Device Scanning Technique in people with Full Arch Implant Rehabilitation, run by Tanta 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 3 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: looking for participants now, as of the sponsor's last update on 2 Oct 2026. 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?
Contact Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc (+201090461713, mostafa_hamed@dent.tanta.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Implant linear and angular deviation (time frame: Immediately after completion of digital scanning day 0). The study lists 2 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 2 Oct 2026; AzTrials last refreshed its copy on 7 Nov 2026.