- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT07740265
Effect of Scanning Techniques on Accuracy of Mandibular Fixed Detachable Prostheses
Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).
Przegląd badań
Status
Warunki
Szczegółowy opis
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.
Typ studiów
Zapisy (Szacowany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Kontakt w sprawie studiów
- Nazwa: Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc
- Numer telefonu: +201090461713
- E-mail: mostafa_hamed@dent.tanta.edu.eg
Lokalizacje studiów
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Gharbia Governorate
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Tanta, Gharbia Governorate, Egipt, 31527
- Rekrutacyjny
- faculty of dentistry, Tanta university
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Kontakt:
- Mostafa Hamed Mostafa Abd El-Hameed
- Numer telefonu: +201090461713
- E-mail: mostafa_hamed@dent.tanta.edu.eg
-
Główny śledczy:
- Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dorosły
Akceptuje zdrowych ochotników
Opis
Inclusion Criteria:
- 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.
Exclusion Criteria:
1-. Insufficient vertical inter-arch space to accommodate the restorative components.
2. Presence of psychiatric or neurological conditions. 3. Any systemic diseases that may affect implant bone osteointegration.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Wykonalność urządzenia
- Przydział: Randomizowane
- Model interwencyjny: Zadanie krzyżowe
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: Splinted Scan Bodies with composite
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.
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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.
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Eksperymentalny: horizontal non-calibrated scan bodies
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.
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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.
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Eksperymentalny: Auxiliary Geometric Device Scanning
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.
|
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.
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Implant linear and angular deviation
Ramy czasowe: Immediately after completion of digital scanning day 0
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The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other
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Immediately after completion of digital scanning day 0
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Three-Dimensional part comparison
Ramy czasowe: Immediately after completion of digital scanning day 0
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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.
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Immediately after completion of digital scanning day 0
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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fit of verification jig
Ramy czasowe: Within 1 hour of fabrication and intraoral placement of the verification jig
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Passive fit will be evaluated clinically using the Sheffield one-screw test and confirmed by intraoral periapical radiographs.
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Within 1 hour of fabrication and intraoral placement of the verification jig
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc, Faculty of Dentistry, Tanta University, Egypt
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Szacowany)
Zakończenie podstawowe (Szacowany)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- RP-11-25-3482
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
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