Influence of Provisional Restoration Type on Outcomes of Immediate Implant Placement and Loading (PRODIGI)
21. juli 2026 opdateret af: Mansoura University
Influence of Provisional Restoration Type on Clinical Outcomes of Fully Digital Single-Visit Immediate Implant Placement and Loading: A Randomized Clinical Trial
A randomized clinical trial comparing 3D-printed resin and CAD/CAM-milled PMMA provisional restorations used for immediate loading of fully digitally guided immediate implants.
Studieoversigt
Status
Aktiv, ikke rekrutterende
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Sixty patients were randomly allocated to receive either a 3D-printed resin or a CAD/CAM-milled PMMA provisional crown used for immediate loading after fully digitally guided immediate implant placement in the maxillary esthetic zone.
Clinical and peri-implant soft tissue outcomes will be evaluated.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
60
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
Dakahlia Governorate
-
Al Mansurah, Dakahlia Governorate, Egypten
- Faculty of Dentistry Mansoura University
-
-
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
Tager imod sunde frivillige
Ingen
Beskrivelse
Inclusion Criteria:
- Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.
- Age ranging from 18 to 50 years.
- Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.
- Intact extraction socket walls with a jumping gap not exceeding 4 mm, as measured on preoperative CBCT images. The jumping gap will be defined as the horizontal distance between the implant surface and the inner aspect of the buccal socket wall and will be grafted in all cases.
- Good oral hygiene and periodontal health.
- Willingness to attend all follow-up visits and comply with study requirements.
Exclusion Criteria:
- Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.
- Smokers.
- Alcohol or drug abuse.
- Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).
- Pregnancy or lactation.
- Patients with parafunctional habits such as bruxism or clenching.
- Inability to maintain adequate oral hygiene or 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: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Study Group 2 (CAD/CAM-Milled PMMA Group)
Thirty patients received a digitally designed CAD/CAM-milled PMMA immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
|
A digitally designed CAD/CAM-milled PMMA immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
|
|
Eksperimentel: Study Group 1 (3D-Printed resin Group)
Thirty patients received a digitally designed 3D-printed resin immediate provisional crown for immediate loading, serving as a customized healing abutment following fully guided immediate implant placement in the maxillary esthetic zone.
|
A digitally designed and 3D-printed resin immediate provisional crown was delivered immediately after fully guided implant placement in the maxillary esthetic zone and served as a customized healing abutment.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Peri-implant soft tissue changes
Tidsramme: Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
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Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
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Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Pink Esthetic Score (PES)
Tidsramme: After 3 and 6 months postoperatively.
|
Peri-implant soft tissue esthetics were assessed using the Pink Esthetic Score (0-14).
Higher scores indicated better esthetic outcomes.
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After 3 and 6 months postoperatively.
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Implant stability
Tidsramme: Immediate post-operative and at 3 months.
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Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
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Immediate post-operative and at 3 months.
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
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)
1. december 2025
Primær færdiggørelse (Faktiske)
30. juni 2026
Studieafslutning (Anslået)
1. juli 2026
Datoer for studieregistrering
Først indsendt
8. juli 2026
Først indsendt, der opfyldte QC-kriterier
8. juli 2026
Først opslået (Faktiske)
14. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
22. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
21. juli 2026
Sidst verificeret
1. juli 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- R.26.06.127
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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