Edentulous JawGPA ScanNCT07065487
Accuracy of Standard and Geometric Pattern-Assisted Digital Scanning for Full-Arch Implant Prosthesis Frameworks
A study testing Intraoral Scanner - Standard Protocol, Intraoral Scanner with Geometric Reference Pattern and Conventional Splinted Impression Technique in people with Edentulous Jaw and Dental Prosthesis, Implant-Supported, run by Mirna ashraf anis heneen at 1 site in Egypt.
Trial summary
This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort. Read more about this study
- Who is it for?
- Ages 30 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Edentulous Jaw, Dental Prosthesis, Implant-Supported, Prosthodontics
- What is being tested?
- Intraoral Scanner - Standard Protocol, Intraoral Scanner with Geometric Reference Pattern and Conventional Splinted Impression Technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteEgypt
- Study dates
- 30 Sep 2025to 15 Jul 2026
- 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 30 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adults aged 30 to 70 years
- Completely edentulous mandible
- Presence of four osseointegrated implants in the lower jaw
- Good oral and general health
- Willingness to participate and provide written informed consent
- Availability for all study appointments
Who cannot join
- Systemic diseases or conditions that affect bone healing or implant integration
- Presence of oral inflammation, infection, or soft tissue abnormalities at implant sites
- History of bruxism or parafunctional habits
- Inability to understand or comply with study procedures
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Accuracy of Standard vs Geometric Pattern-Assisted Digital Scanning Techniques for Construction of Full Arch Implant Prosthesis Framework: A Crossover Study
This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort.
In this crossover study, participants with four osseointegrated dental implants in the lower jaw will undergo three types of impressions:
Read more
Conventional splinted impression using polyvinyl siloxane (PVS) material.
Standard digital impression using an intraoral scanner.
Geometric pattern-assisted digital impression, which incorporates a visual reference pattern to improve scan alignment and accuracy.
Each participant will receive all three impression techniques in a randomized sequence, at different time points. The accuracy of each method will be assessed by evaluating the passivity of the resulting prosthetic frameworks using two methods: (1) digital superimposition analysis to measure three-dimensional (3D) spatial deviation, and (2) the clinical "one-screw test" to detect misfit.
The study seeks to determine whether digital scanning, particularly with geometric pattern assistance, can provide accuracy comparable to or better than conventional methods. Findings may guide improvements in digital prosthodontic workflows and support more efficient, predictable treatment outcomes.
Read the detailed description
This is a prospective, crossover clinical trial designed to evaluate and compare the accuracy of three different impression techniques used in the fabrication of full-arch implant-supported prosthesis frameworks. The study includes four participants, each with four osseointegrated dental implants in the mandibular arch.
The three impression techniques being compared are:
Conventional Splinted Impressions: A traditional method utilizing rigidly splinted impression copings and polyvinyl siloxane (PVS) impression material to capture implant positions.
Standard Digital Scanning: A fully digital technique using an intraoral scanner and scan bodies placed on the implants to generate a digital impression.
Geometric Pattern-Assisted Digital Scanning: An enhanced digital method incorporating a geometric reference pattern during the scanning process to improve stitching accuracy and reduce scan distortion across the arch.
Each participant will receive all three impression techniques in a randomized sequence to minimize order bias. Digital models will be generated from each impression method, and test frameworks will be designed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology. These frameworks will be fabricated using 3D laser sintering.
The primary outcome of the study is the assessment of accuracy, defined as the mean three-dimensional (3D) deviation between the test scan and a reference scan, measured via digital superimposition software. A secondary outcome is clinical passivity, evaluated using the one-screw test to detect any misfit between the framework and implant interfaces.
The results of this study aim to provide clinical evidence regarding the accuracy and feasibility of advanced digital impression techniques, particularly the use of geometric pattern references, in full-arch implant prosthodontics. This may support improvements in digital workflow reliability, patient outcomes, and prosthetic longevity.
- Conditions
- Edentulous Jaw, Dental Prosthesis, Implant-Supported, Prosthodontics, Dental Implantation, Endosseous
- Being tested
- Intraoral Scanner - Standard Protocol, Intraoral Scanner with Geometric Reference Pattern, Conventional Splinted Impression Technique
- Keywords
- Digital impression, Full-arch implant, Geometric pattern, Prosthesis framework, Intraoral scanner, Splinted impression, CAD/CAM prosthodontics, Passive fit, Dental implants
- Medical subject headings
- Jaw, Edentulous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intraoral Scanner - Standard ProtocolDevice
A full-arch digital impression is obtained using a high-precision intraoral scanner. Scan bodies are placed on multi-unit abutments and scanned without the use of external reference markers or geometric aids. The scan follows the manufacturer-recommended scanning path to capture the complete arch. This serves as a baseline digital technique for comparison with geometric pattern-assisted scanning.
Intraoral Scanner with Geometric Reference PatternDevice
The same intraoral scanner is used, but with an additional geometric reference pattern introduced in the scanning field to improve stitching accuracy and alignment of the digital scan.
Conventional Splinted Impression TechniqueProcedure or surgery
A physical impression is taken using open-tray impression copings splinted with DuraLay resin and polyvinyl siloxane (PVS) material in a custom tray, according to conventional protocols for full-arch implant prostheses.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Splinted Impression | Experimental | Participants will undergo a conventional impression technique using open-tray impression copings rigidly splinted with DuraLay resin. The impression is taken using polyvinyl siloxane (PVS) material in a custom tray. This method serves as the control for comparison with digital techniques. Receives: Procedure: Conventional Splinted Impression Technique |
| Standard Digital Scan | Experimental | Participants will undergo a full-arch digital scan using an intraoral scanner. Scan bodies will be attached to the multi-unit abutments, and the scan will be performed without any additional geometric reference aids. Receives: Device: Intraoral Scanner - Standard Protocol |
| Geometric Pattern-Assisted Digital Scan | Experimental | Participants will undergo a full-arch digital scan using an intraoral scanner, with the addition of a geometric reference pattern placed in the scanning field to improve stitching accuracy and scan reliability. Receives: Device: Intraoral Scanner with Geometric Reference Pattern |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean 3D deviation (in microns) between test and reference scans using digital superimposition.
Accuracy will be assessed by digitally superimposing the scan obtained from each method (conventional splinted impression, standard digital scan, geometric pattern-assisted digital scan) onto a reference scan (conventional method). Specialized software will calculate the mean 3D deviation in microns to quantify spatial accuracy. Lower deviation indicates higher accuracy.
Measured: Immediately after each impression session (Day 0 for each method).
Secondary outcomes (1)
Number of frameworks exhibiting passive fit as determined by the one-screw test.
Clinical assessment of framework passivity will be performed using the one-screw test. A passive fit will be recorded if no lifting or rocking is observed upon tightening a single screw at one end of the framework while the others remain untightened. Count and percentage of frameworks with passive fit will be reported.
Measured: Within 1 hour of framework placement following each impression method.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jul 2025
- Study start30 Sep 2025
- Primary completion11 Jul 2026
- Study completion15 Jul 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Edentulous JawStudies of the same condition, open and under way.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- randomized crossover clinical trial
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mirna ashraf anis heneen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Mirna ashraf anis heneen, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07065487
- Sponsor's protocol ID
- MU-PROS-2025-001
- Acronym
- GPA Scan
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2025
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data (IPD), including digital scan accuracy values and framework fit results, will be made available upon reasonable request after publication of the study results. Data will be shared with qualified researchers for academic and non-commercial purposes only, subject to ethical approval and data-sharing agreements.
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Accuracy of Standard vs Geometric Pattern-Assisted Digital Scanning Techniques for Construction of Full Arch Implant Prosthesis Framework: A Crossover Study
- ClinicalTrials.gov ID
- NCT07065487
- Acronym / sponsor ID
- GPA Scan / MU-PROS-2025-001
- Conditions
- Edentulous Jaw, Dental Prosthesis, Implant-Supported, Prosthodontics, Dental Implantation, Endosseous
- Keywords
- Digital impression, Full-arch implant, Geometric pattern, Prosthesis framework, Intraoral scanner, Splinted impression, CAD/CAM prosthodontics, Passive fit
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Mirna ashraf anis heneenUniversity, hospital or other
- Study start
- 30 Sep 2025 (actual)
- Primary completion
- 11 Jul 2026 (actual)
- Study completion
- 15 Jul 2026 (actual)
- First posted
- 15 Jul 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.
This clinical trial aims to compare three different impression techniques used to fabricate full-arch implant-supported dental prostheses. Accurate impressions are essential to ensure a passive and precise fit of the final prosthetic framework, which contributes to long-term implant success and patient comfort.
In this crossover study, participants with four osseointegrated dental implants in the lower jaw will undergo three types of impressions:
Conventional splinted impression using polyvinyl siloxane (PVS) material.
Standard digital impression using an intraoral scanner.
Geometric pattern-assisted digital impression, which incorporates a visual reference pattern to improve scan alignment and accuracy.
Each participant will receive all three impression techniques in a randomized sequence, at different time points. The accuracy of each method will be assessed by evaluating the passivity of the resulting prosthetic frameworks using two methods: (1) digital superimposition analysis to measure three-dimensional (3D) spatial deviation, and (2) the clinical "one-screw test" to detect misfit.
The study seeks to determine whether digital scanning, particularly with geometric pattern assistance, can provide accuracy comparable to or better than conventional methods. Findings may guide improvements in digital prosthodontic workflows and support more efficient, predictable treatment outcomes.
Detailed description
This is a prospective, crossover clinical trial designed to evaluate and compare the accuracy of three different impression techniques used in the fabrication of full-arch implant-supported prosthesis frameworks. The study includes four participants, each with four osseointegrated dental implants in the mandibular arch.
The three impression techniques being compared are:
Conventional Splinted Impressions: A traditional method utilizing rigidly splinted impression copings and polyvinyl siloxane (PVS) impression material to capture implant positions.
Standard Digital Scanning: A fully digital technique using an intraoral scanner and scan bodies placed on the implants to generate a digital impression.
Geometric Pattern-Assisted Digital Scanning: An enhanced digital method incorporating a geometric reference pattern during the scanning process to improve stitching accuracy and reduce scan distortion across the arch.
Each participant will receive all three impression techniques in a randomized sequence to minimize order bias. Digital models will be generated from each impression method, and test frameworks will be designed using computer-aided design/computer-aided manufacturing (CAD/CAM) technology. These frameworks will be fabricated using 3D laser sintering.
The primary outcome of the study is the assessment of accuracy, defined as the mean three-dimensional (3D) deviation between the test scan and a reference scan, measured via digital superimposition software. A secondary outcome is clinical passivity, evaluated using the one-screw test to detect any misfit between the framework and implant interfaces.
The results of this study aim to provide clinical evidence regarding the accuracy and feasibility of advanced digital impression techniques, particularly the use of geometric pattern references, in full-arch implant prosthodontics. This may support improvements in digital workflow reliability, patient outcomes, and prosthetic longevity.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- randomized crossover clinical trial
| Arm | Type | Receives |
|---|---|---|
| Conventional Splinted Impression | Experimental | Procedure: Conventional Splinted Impression TechniqueParticipants will undergo a conventional impression technique using open-tray impression copings rigidly splinted with DuraLay resin. The impression is taken using polyvinyl siloxane (PVS) material in a custom tray. This method serves as the control for comparison with digital techniques. |
| Standard Digital Scan | Experimental | Device: Intraoral Scanner - Standard ProtocolParticipants will undergo a full-arch digital scan using an intraoral scanner. Scan bodies will be attached to the multi-unit abutments, and the scan will be performed without any additional geometric reference aids. |
| Geometric Pattern-Assisted Digital Scan | Experimental | Device: Intraoral Scanner with Geometric Reference PatternParticipants will undergo a full-arch digital scan using an intraoral scanner, with the addition of a geometric reference pattern placed in the scanning field to improve stitching accuracy and scan reliability. |
Who may qualify
- Ages
- 30 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adults aged 30 to 70 years
- Completely edentulous mandible
- Presence of four osseointegrated implants in the lower jaw
- Good oral and general health
- Willingness to participate and provide written informed consent
Key exclusion criteria (4 listed)
- Systemic diseases or conditions that affect bone healing or implant integration
- Presence of oral inflammation, infection, or soft tissue abnormalities at implant sites
- History of bruxism or parafunctional habits
- Inability to understand or comply with study procedures
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 |
|---|---|---|
| Intraoral Scanner - Standard ProtocolA full-arch digital impression is obtained using a high-precision intraoral scanner. Scan bodies are placed on multi-unit abutments and scanned without the use of external reference markers or geometric aids. The scan follows the manufacturer-recommended scanning path to capture the complete arch. This serves as a baseline digital technique for comparison with geometric pattern-assisted scanning. | Device | Standard Digital Scan |
| Intraoral Scanner with Geometric Reference PatternThe same intraoral scanner is used, but with an additional geometric reference pattern introduced in the scanning field to improve stitching accuracy and alignment of the digital scan. | Device | Geometric Pattern-Assisted Digital Scan |
| Conventional Splinted Impression TechniqueA physical impression is taken using open-tray impression copings splinted with DuraLay resin and polyvinyl siloxane (PVS) material in a custom tray, according to conventional protocols for full-arch implant prostheses. | Procedure or surgery | Conventional Splinted Impression |
Primary outcome
Mean 3D deviation (in microns) between test and reference scans using digital superimposition.
Time frame: Immediately after each impression session (Day 0 for each method).
Accuracy will be assessed by digitally superimposing the scan obtained from each method (conventional splinted impression, standard digital scan, geometric pattern-assisted digital scan) onto a reference scan (conventional method). Specialized software will calculate the mean 3D deviation in microns to quantify spatial accuracy. Lower deviation indicates higher accuracy.
1 secondary outcome
Number of frameworks exhibiting passive fit as determined by the one-screw test.
Time frame: Within 1 hour of framework placement following each impression method.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data (IPD), including digital scan accuracy values and framework fit results, will be made available upon reasonable request after publication of the study results. Data will be shared with qualified researchers for academic and non-commercial purposes only, subject to ethical approval and data-sharing agreements.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intraoral Scanner - Standard Protocol, Intraoral Scanner with Geometric Reference Pattern and Conventional Splinted Impression Technique in people with Edentulous Jaw and Dental Prosthesis, Implant-Supported, run by Mirna ashraf anis heneen 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 6 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: finished, as of the sponsor's last update on 15 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Mean 3D deviation (in microns) between test and reference scans using digital superimposition. (time frame: Immediately after each impression session (Day 0 for each method).). 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 15 Oct 2026.