- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07643441
Accuracy of Complete-Arch Implant Photogrammetry
Accuracy of Complete-arch Implant Scans Obtained Using Intraoral Photogrammetry and a Mobile-phone Based Photogrammetry.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Mohammed El-Sawy, PhD
- Telefonnummer: 00201061314522
- E-post: mohamed.elsawy@dent.menofia.edu.eg
Studiesteder
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Menoufia
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Shibīn al Kawm, Menoufia, Egypt, 2266166
- Rekruttering
- Mohammed El-Sawy
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Ta kontakt med:
- Mohammed Elsawy
- E-post: mohamed.elsawy@dent.menofia.edu.eg
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
Beskrivelse
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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.
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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.
Andre navn:
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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.
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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.
Andre navn:
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Linear Discrepancy of Complete-Arch Implant Scans
Tidsramme: Immediately after scan acquisition and digital analysis (same study visit).
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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.
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Immediately after scan acquisition and digital analysis (same study visit).
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Samarbeidspartnere og etterforskere
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Mohammed A. El-Sawy, PhD, Menoufia University
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ADMNF-000026
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
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