Mansoura University
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
Location contact
Khaled Zahran, Ph.D.
CONTACT
Mirna Ashraf Anis, B.D.S., M.D.S.
PRINCIPAL_INVESTIGATOR
Mirna Ashraf, B.D.S., M.D.S.
CONTACT
NCT Number: NCT07065487
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.
Interested in participating?
Request Info30 year–70 year
All sexes
Interventional
Not applicable
Al Mansurah, Dakahlia Governorate, 35516, Egypt
Location status: Recruiting
Khaled Zahran, Ph.D.
CONTACT
Mirna Ashraf Anis, B.D.S., M.D.S.
PRINCIPAL_INVESTIGATOR
Mirna Ashraf, B.D.S., M.D.S.
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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 informed consent
Availability for all study appointments
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
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.
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.
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.
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.
Time frame: Within 1 hour of framework placement following each impression method.
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.
Contact information is provided by the study sponsor or research team.
Mirna ashraf anis heneen
Other
Accuracy of Standard vs Geometric Pattern-Assisted Digital Scanning Techniques for Construction of Full Arch Implant Prosthesis Framework: A Crossover Study
Acronym: GPA Scan
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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