Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions
20. august 2026 oppdatert av: Ahmed Hazem Elsayed Helmi, Mansoura University
Passive Fit Evaluation of Full-Arch Implant-supported Frameworks Using Digital and Conventional Impression Techniques: Crossover Study
This randomized crossover clinical trial compares the passivity of fit of complete-arch mandibular implant-supported frameworks fabricated using three impression techniques: a non-calibrated splinted digital scan body system (IO-Connect), a Reverse Scan Body (RSB) digital impression technique, and a conventional splinted open-tray impression technique.
Eight completely edentulous patients each receiving four mandibular implants will be included.
Passivity of fit will be evaluated clinically using the Sheffield one-screw test and radiographically using intraoral periapical radiographs obtained with the parallel technique.
Studieoversikt
Status
Rekruttering
Detaljert beskrivelse
Full-arch implant-supported fixed prostheses require a high degree of passive fit to avoid mechanical and biological complications. While digital impression workflows are increasingly used as alternatives to conventional splinted impressions, evidence directly comparing their clinical accuracy for complete-arch implant frameworks remains limited, particularly for the IO-Connect non-calibrated splinting system and the Reverse Scan Body technique.
Eight completely edentulous patients with at least four mandibular implants will be enrolled. Using a crossover design, each patient will undergo all three impression techniques: Group I (IO-Connect splinted scan bodies), Group II (Reverse Scan Body technique), and Group III (conventional splinted open-tray impression with polyvinyl siloxane and Type IV stone casts). For each technique, a corresponding implant-supported framework will be fabricated and evaluated for passivity of fit using the Sheffield one-screw test and periapical radiographs taken with a paralleling device to assess microgaps at the implant-framework interface.
Studietype
Intervensjonell
Registrering (Antatt)
8
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Ahmed H Hazem Elsayed Helmi Atwa, BDS
- Telefonnummer: +20 1092758696
- E-post: ahmedhazem@mans.edu.eg
Studiesteder
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Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypt
- Rekruttering
- Faculty of Dentistry, Mansoura University
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Ta kontakt med:
- Ahmed H Hazem Elsayed Helmi Atwa, BDS
- Telefonnummer: +20 1092758696
- E-post: ahmedhazem@mans.edu.eg
-
Hovedetterforsker:
- Ahmed Hazem Elsayed Helmi Atwa, BDS
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-
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
- Eldre voksen
Tar imot friske frivillige
Nei
Beskrivelse
Inclusion Criteria:
- Completely edentulous patients requiring full-arch implant-supported fixed prosthesis
- Age 35-70 years
- Adequate mandibular bone to place at least four implants without major grafting
- Ability to undergo digital scanning and radiographic evaluation
- Signed informed consent
Exclusion Criteria:
- Systemic conditions affecting healing (uncontrolled diabetes, immunosuppression)
- History of head/neck radiotherapy or bisphosphonate therapy
- Active oral infection or severe bruxism
- Strong gag reflex preventing accurate scanning
- Poor compliance or unwillingness to attend follow-up visits
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Aktiv komparator: Group I: IO-Connect
Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with IO-Connect non-calibrated splinted scan bodies.
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Digital impression of the mandibular arch obtained using IO-Connect non-calibrated splinted scan bodies to fabricate the implant-supported framework for Group I.
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Aktiv komparator: Group II: Reverse Scan Body
Patients received complete-arch implant-supported frameworks fabricated using digital impressions obtained with the Reverse Scan Body (RSB) technique.
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Digital impression obtained using the Reverse Scan Body (RSB) technique, involving extraoral scanning of scan bodies and superimposition with intraoral tissue scans, to fabricate the implant-supported framework for Group II.
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Aktiv komparator: Group III: Conventional Impression
Patients received complete-arch implant-supported frameworks fabricated using a conventional splinted open-tray impression technique.
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Conventional splinted open-tray impression using polyvinyl siloxane material and Type IV dental stone to fabricate the implant-supported framework for Group III.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Passive Fit Assessed by Sheffield One-Screw Test
Tidsramme: The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.
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The framework was seated on all implants and a single distal screw was fully tightened; remaining screw sites were examined visually and tactilely for lifting, rocking, or gaps as an indicator of passive fit.
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The evaluation of passive fit by Sheffield one-screw test will be done 3 months after implant placement (3M-IP), at framework try-in for each of the three impression techniques.
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Passive Fit Assessed by Periapical Radiographs
Tidsramme: The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
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Intraoral periapical radiographs were obtained at each implant site using a paralleling device and evaluated for microgaps at the implant-framework interface.
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The evaluation of passive fit by periapical radiographs will be done 3 months after implant placement, at framework try-in for each of the three impression techniques.
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Fatma A El-Waseef, PhD, Mansoura University
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 (Faktiske)
25. januar 2026
Primær fullføring (Antatt)
25. oktober 2026
Studiet fullført (Antatt)
25. januar 2027
Datoer for studieregistrering
Først innsendt
6. august 2026
Først innsendt som oppfylte QC-kriteriene
20. august 2026
Først lagt ut (Faktiske)
21. august 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
21. august 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
20. august 2026
Sist bekreftet
1. august 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- MS.25-12-95
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