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Effect of Scanning Techniques on Accuracy of Mandibular Fixed Detachable Prostheses

28. juli 2026 oppdatert av: Mostafa Hamed Mostafa Abd El-Hameed, Tanta University

Influence of Three Different Scanning Techniques on Scanning Accuracy for Mandibular Fixed Detachable Prosthesis (A Cross Over Study).

This crossover clinical study aims to evaluate the influence of three different intraoral scanning techniques on the scanning accuracy and passive fit of mandibular implant-supported fixed detachable prostheses in completely edentulous patients. Each participant will undergo digital implant scanning using three methods: splinted scan bodies, horizontal non-calibrated scan bodies (IO Connect), and auxiliary geometric devices.

Studieoversikt

Detaljert beskrivelse

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:

  1. Splinted Scan Bodies: Implant scan bodies will be splinted using composite resin before intraoral scanning.
  2. Horizontal Non-Calibrated Scan Bodies (IO Connect): Digital impressions will be obtained using the IO Connect horizontal scan body system.
  3. 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.

Studietype

Intervensjonell

Registrering (Antatt)

7

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiekontakt

Studiesteder

    • Gharbia Governorate
      • Tanta, Gharbia Governorate, Egypt, 31527
        • Rekruttering
        • faculty of dentistry, Tanta university
        • Ta kontakt med:
        • Hovedetterforsker:
          • Mostafa Hamed Mostafa Abd El-Hameed, BDS, MSc

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen

Tar imot friske frivillige

Ja

Beskrivelse

Inclusion Criteria:

  1. Completely edentulous patients with age between 40-60 years.
  2. Adequate bone height to fulfill the criteria for implant placement.
  3. 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.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Enhetens gjennomførbarhet
  • Tildeling: Randomisert
  • Intervensjonsmodell: Crossover-oppdrag
  • Masking: Ingen (Open Label)

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Eksperimentell: 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.
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.
Eksperimentell: 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.
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.
Eksperimentell: 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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Implant linear and angular deviation
Tidsramme: Immediately after completion of digital scanning day 0
The linear and angular deviations of implants will be compared and analyzed across different scanning techniques against each other
Immediately after completion of digital scanning day 0
Three-Dimensional part comparison
Tidsramme: Immediately after completion of digital scanning day 0
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.
Immediately after completion of digital scanning day 0

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
fit of verification jig
Tidsramme: Within 1 hour of fabrication and intraoral placement of the verification jig
Passive fit will be evaluated clinically using the Sheffield one-screw test and confirmed by intraoral periapical radiographs.
Within 1 hour of fabrication and intraoral placement of the verification jig

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Hovedetterforsker: Mostafa Hamed Mostafa Abd El-Hameed Abd El-Hameed, BDS, MSc, Faculty of Dentistry, Tanta University, Egypt

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Antatt)

8. august 2026

Primær fullføring (Antatt)

1. april 2027

Studiet fullført (Antatt)

1. juli 2027

Datoer for studieregistrering

Først innsendt

28. juli 2026

Først innsendt som oppfylte QC-kriteriene

28. juli 2026

Først lagt ut (Faktiske)

31. juli 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

31. juli 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

28. juli 2026

Sist bekreftet

1. juli 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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