Passive Fit of Implant-Supported Frameworks: Digital vs Conventional Impressions
20. august 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Detaljeret 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.
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
8
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ahmed H Hazem Elsayed Helmi Atwa, BDS
- Telefonnummer: +20 1092758696
- E-mail: ahmedhazem@mans.edu.eg
Studiesteder
-
-
Dakahlia Governorate
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Al Mansurah, Dakahlia Governorate, Egypten
- Rekruttering
- Faculty of Dentistry, Mansoura University
-
Kontakt:
- Ahmed H Hazem Elsayed Helmi Atwa, BDS
- Telefonnummer: +20 1092758696
- E-mail: ahmedhazem@mans.edu.eg
-
Ledende efterforsker:
- Ahmed Hazem Elsayed Helmi Atwa, BDS
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
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
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Crossover opgave
- Maskning: Ingen (Åben etiket)
Våben og indgreb
Deltagergruppe / Arm |
Intervention / 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
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.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Efterforskere
- Studiestol: Fatma A El-Waseef, PhD, Mansoura University
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
25. januar 2026
Primær færdiggørelse (Anslået)
25. oktober 2026
Studieafslutning (Anslået)
25. januar 2027
Datoer for studieregistrering
Først indsendt
6. august 2026
Først indsendt, der opfyldte QC-kriterier
20. august 2026
Først opslået (Faktiske)
21. august 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
21. august 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
20. august 2026
Sidst verificeret
1. august 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MS.25-12-95
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