Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Influence of Provisional Restoration Type on Outcomes of Immediate Implant Placement and Loading (PRODIGI)

8. 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

  • Egypten
    • 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:

  • 1. Patients presenting with non-restorable teeth in the maxillary esthetic zone indicated for extraction and immediate implant placement.

    2. Age ranging from 18 to 50 years. 3. Adequate interarch relationship and interocclusal space to accommodate the planned prosthetic restoration.

    4. 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.

    5. Good oral hygiene and periodontal health. 6. Willingness to attend all follow-up visits and comply with study requirements.

Exclusion Criteria:

  • 1. Presence of acute infection, pathological lesions, or severe periodontal disease at the planned implant site.

    2. Smokers. 3. Alcohol or drug abuse. 4. Patients with systemic conditions contraindicating implant surgery (e.g., uncontrolled diabetes mellitus, bleeding disorders, immunosuppression, recent radiotherapy to the head and neck region).

    5. Pregnancy or lactation. 6. Patients with parafunctional habits such as bruxism or clenching. 7. 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 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 placementin the maxillary esthetic zone.
Procedure: 3D-Printed Resin Provisional Crown
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.
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.
Procedure: CAD/CAM-Milled PMMA Provisional Crown
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.

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.
Soft tissue contour and peri-implant tissue condition will be assessed using digital intraoral scanning (STL files) using superimposition.
Baseline (immediately after provisionalization), 1 month, 3 months, and 6 months postoperatively.

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.
After 3 and 6 months postoperatively.
Implant stability
Tidsramme: Immediate post-operative and at 3 months.
Implant stability will be evaluated using Osstell device based on resonance frequency analysis (ISQ values).
Immediate post-operative and at 3 months.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

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)

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)

14. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. 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)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Umiddelbar tandimplantatplacering

Kliniske forsøg med 3D-Printed Resin Provisional Crown

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Denmark

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

3
Abonner