- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07643441
Accuracy of Complete-Arch Implant Photogrammetry
Accuracy of Complete-arch Implant Scans Obtained Using Intraoral Photogrammetry and a Mobile-phone Based Photogrammetry.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
Accurate recording of implant positions is essential for the passive fit and long-term success of complete-arch implant-supported prostheses. Photogrammetry-based technologies have emerged as promising alternatives to conventional digital impression techniques for capturing implant positions with high accuracy. While intraoral photogrammetry systems have demonstrated favorable results, the clinical performance of recently introduced mobile-phone-based photogrammetry systems remains insufficiently investigated.
This prospective comparative clinical study aims to evaluate the accuracy and chairside time of complete-arch implant scans obtained using an intraoral photogrammetry system and a mobile-phone-based photogrammetry system in edentulous patients restored with complete-arch implant-supported prostheses. Each participant will undergo implant scanning using both systems according to the manufacturers' recommendations. The resulting digital datasets will be compared with a reference dataset to determine scan accuracy.
The primary outcome measures will be linear and angular discrepancies between the implant positions captured by each photogrammetry system and the reference dataset. Secondary outcome measures will include the chairside time required for scan acquisition. Statistical analyses will be performed to compare the accuracy and efficiency of the evaluated systems.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
-
-
Menoufia
-
Shibīn al Kawm, Menoufia, Egypten, 2266166
- Mohammed El-Sawy
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
Inclusion Criteria:
- Adults aged 18 years or older.
- Completely edentulous patients rehabilitated with implant-supported complete-arch prostheses.
- Presence of at least four osseointegrated implants in the edentulous arch.
- Patients able to undergo digital implant scanning procedures.
- Patients willing to participate and provide written informed consent.
Exclusion Criteria:
- Patients with unstable or failed implants.
- Presence of peri-implant disease, active oral infection, or significant soft-tissue inflammation around the implants.
- Inadequate access for placement of photogrammetry scan bodies or markers.
- Patients with conditions that prevent proper scanning procedures (e.g., inability to maintain mouth opening or remain still during data acquisition).
- Patients requiring immediate implant placement or immediate loading protocols.
- Patients unwilling or unable to provide informed consent.
- Incomplete clinical records or inability to complete all study procedures.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
Intervention / Behandling |
|---|---|
|
Intraoral Photogrammetry (IPG)
Participants will undergo complete-arch implant scanning using an intraoral photogrammetry system (IPF Elite, Shining 3D).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
|
A photogrammetry-based digital impression system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system records implant locations through specialized scan bodies and generates a digital dataset for subsequent accuracy analysis.
Andra namn:
|
|
Mobile-Phone-Based Photogrammetry
Participants will undergo complete-arch implant scanning using a mobile-phone-based photogrammetry system (T-Marker).
Implant positions will be digitally recorded according to the manufacturer's instructions.
Linear and angular discrepancies relative to the reference dataset, as well as chairside scanning time, will be evaluated.
|
A smartphone-assisted photogrammetry system used to capture the three-dimensional positions of implants in complete-arch rehabilitations.
The system acquires photographic data through coded markers and generates a digital dataset for subsequent accuracy analysis.
Andra namn:
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Linear Discrepancy of Complete-Arch Implant Scans
Tidsram: Immediately after scan acquisition and digital analysis (same study visit).
|
Assessment of the linear deviation (μm) between implant positions captured using intraoral photogrammetry and mobile-phone-based photogrammetry systems and those recorded in the reference dataset.
Lower values indicate greater accuracy.
|
Immediately after scan acquisition and digital analysis (same study visit).
|
Samarbetspartners och utredare
Sponsor
Samarbetspartners
Utredare
- Huvudutredare: Mohammed A. El-Sawy, PhD, Menoufia University
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- R.26.125
Plan för individuella deltagardata (IPD)
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IPD-planbeskrivning
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