ClinicalTrials.gg
CompletedNCT07065487GPA ScanUpdated Oct 15, 2026

Accuracy of Standard and Geometric Pattern-Assisted Digital Scanning for Full-Arch Implant Prosthesis Frameworks

An interventional study of Intraoral Scanner - Standard Protocol and Intraoral Scanner with Geometric Reference Pattern in Edentulous Jaw, Dental Prosthesis, Implant-Supported and Prosthodontics, sponsored by Mirna ashraf anis heneen. Completed at 1 site in Egypt. Open to participants aged 30 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-10-15.

Sponsored by Mirna ashraf anis heneen · Not applicable, Interventional, and Diagnostic

Updated Oct 15, 2026Now CompletedPrimary completion moved+2 moreGo to Updates ↓
Phase
Not applicable
Study type
Interventional
Enrollment
4
Allocation
Randomized
Ages
30 Years to 70 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-13

Among 25 studies in Jaw, Edentulous with a site in Egypt — 3 open to participants now, 7 under way, none of them phase 3. Jaw, Edentulous · Egypt.

Enrollment
23rd of 23
4 · median 20
Started
2025
with 2 others
No phase
23 of 25
3 open now
Registered
17th of 25
by date

Among the 25 studies in Jaw, Edentulous with a site in Egypt, this one is the 23rd largest by enrollment of the 23 interventional ones that give a count, is one of 3 that started in 2025, is one of 23 with no phase, and was the 17th registered.

Jaw, Edentulous

122 studies on the registry are indexed under Jaw, Edentulous; 20 are open to participants now.

Browse Jaw, Edentulous studies →

Open to participants now

3 of the 25 studies in Jaw, Edentulous with a site in Egypt are open now. Recruiting first, the newest first:

All 3 open studies →

A study can be open while its sites in Egypt have not opened yet or have stopped. Only those recruiting at a site in Egypt →

Who these studies take

Of the 9 Jaw, Edentulous studies recruiting now, 4 set no upper age limit and 4 stop at 75 or younger; 1 takes children under 18; 5 take healthy volunteers.

This study: 30 Years to 70 Years · all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 25 studies in Jaw, Edentulous with a site in Egypt, or all of them as a file.
02

Study 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.

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.

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.

03

Conditions studied

  • Edentulous Jaw
  • Dental Prosthesis, Implant-Supported
  • Prosthodontics
  • Dental Implantation, Endosseous

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Keywords

  • Digital impression
  • Full-arch implant
  • Geometric pattern
  • Prosthesis framework
  • Intraoral scanner
  • Splinted impression
  • CAD/CAM prosthodontics
  • Passive fit
  • Dental implants
04

Who can participate

Ages eligible
30 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Availability for all study appointments

Exclusion criteria

Exclusion Criteria:

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

Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Crossover assignment
Masking
None (open label)
Enrollment
4 participants (actual)

Study arms

  • Experimental
    Conventional Splinted Impression

    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.

    Procedure: Conventional Splinted Impression Technique

  • Experimental
    Standard Digital Scan

    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.

    Device: Intraoral Scanner - Standard Protocol

  • Experimental
    Geometric Pattern-Assisted Digital Scan

    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.

    Device: Intraoral Scanner with Geometric Reference Pattern

Interventions

  • DeviceIntraoral Scanner - Standard Protocol

    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.

  • DeviceIntraoral Scanner with Geometric Reference Pattern

    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.

  • ProcedureConventional Splinted Impression Technique

    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.

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 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.

    Time frame: Within 1 hour of framework placement following each impression method.

07

Study locations

1 site
  • Mansoura University
    Al Mansurah, Dakahlia Governorate 35516, Egypt
08

References and documents

Individual participant data

Plan to share: 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.

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report

Time frame: Beginning 6 months after publication of the study results and for up to 5 years.

Access criteria: De-identified individual participant data (IPD) and supporting materials (study protocol, statistical analysis plan, and informed consent form) will be available to qualified researchers affiliated with academic institutions or non-profit organizations. Access will be granted for non-commercial, ethically approved research purposes. Interested researchers must submit a formal request to the Principal Investigator via email, including a research proposal and institutional ethical approval. Access will be provided through secure, password-protected file sharing platforms.

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Sep 2025 to primary completion in Jul 2026, 9 months.

Of 58 non-industry interventional studies with no phase under Jaw, Edentulous, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 30. This study's 9 months is below that.

Counting every sponsor, half of 66 studies reached it within 20 months; a quarter within 12 and three quarters within 38.

Since we started tracking on Sep 25, 2026, the dates moved once, on Oct 15, 2026: primary completion Sep 2026 → Jul 2026 and completion Sep 2026 → Jul 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Jun 20, 2025
First posted
Jul 15, 2025
StartActual
Sep 30, 2025
Primary completionActual
Jul 11, 2026was Sep 2026
CompletionActual
Jul 15, 2026was Sep 2026
Last update
Oct 15, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Recruiting→Completed
changed Oct 15, 2026
Primary completion
Sep 15, 2026→Jul 11, 2026 (actual)
Oct 15, 2026
Study completion
Sep 15, 2026→Jul 15, 2026 (actual)
Oct 15, 2026
Show all 1 update
  1. Oct 15, 2026
    Recruiting→Completed
    Primary completion Sep 15, 2026→Jul 11, 2026 (now actual)
    Study completion Sep 15, 2026→Jul 15, 2026 (now actual)
    + 3 other changes: verification date, contact details and site details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07065487
Lead sponsor
Mirna ashraf anis heneen
Responsible party
Mirna ashraf anis heneen (Assistant Lecturer of Prosthodontics, Horus University, Damietta - PhD Candidate, Mansoura University, Mansoura University) — Sponsor-investigator
First posted
Jul 15, 2025
Start date
Sep 30, 2025
Primary completion
Jul 11, 2026
Completion
Jul 15, 2026
Last update
Oct 15, 2026

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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