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Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study

1. juni 2026 opdateret af: University Medical Center Groningen

• Background There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes. It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation/reconstruction in the maxillary esthetic zone.

One recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional three-dimensionally printed provisional crowns and allows for rapid additive production of prosthetic restorations.

Until date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction.

  • Main research question The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns.
  • Design (including population, confounders/outcomes) The study design is a prospective, single-arm observational study for evaluation of 30 patients with a failing tooth in the maxillary aesthetic region to be treated with an implant-supported provisional and definitive restoration by means of a provisional and definitive crown. Outcomes: registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.
  • Expected results Satisfying results for patients and professionals (VAS-scores and PES/WES-scores)

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

• Introduction and rationale There is a growing tendency to place a provisional crown immediately following implant placement. Clinical advantages are shortening of treatment duration and soft tissue guiding during healing resulting in better aesthetic outcomes (El Ghoul & Chidiac, 2012). It was shown that good esthetic results can be achieved on the long term with immediate provisionalization of single-tooth implants placed in either fresh extraction sockets or after alveolar ridge preservation/reconstruction in the maxillary esthetic zone (Donker et al., 2024; Meijer et al., 2025).

The popularity of immediate implant loading is related to evolving society factors, including more demanding patients and a wish for direct treatment (Huynh-Ba et al., 2018). Developments in the digital workflow in implant dentistry made treatment planning with the use of intra-oral scans and cone-beam computed tomography (CBCT) and fabrication of a provisional restoration using three-dimensional printers for additive manufacturing possible, further shortening the treatment duration. It was shown that patients prefer intra-oral scanning over analog impression taking (Schepke et al., 2015). Thus, it can be assumed that a digital workflow has advantages over an analog workflow for both the clinician and patients. One recent development in three-dimensional printing is digital press stereolithography (DPS), which overcomes the challenges of printing highly-filled viscous materials. This enables the use of more durable materials than traditional provisional crowns and allows for rapid additive production of prosthetic restorations.

Until date, no studies have been described investigating immediate loading of implants in the aesthetic zone using three-dimensional DPS-printers and their impact on patient-satisfaction.

The purpose of this one-year prospective case series study is to perform an assessment of patient-reported outcomes of single-tooth implants with immediate provisionalization using three-dimensionally printed provisional crowns, with respect to registration of time/complications during the diagnostic/planning/manufacturing process, evaluation of clinical and radiographical performance and aesthetic outcome.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

30

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Holland
    • Provincie Groningen
      • Groningen, Provincie Groningen, Holland, 9700RB
        • University Medical Center Groningen
        • Ledende efterforsker:
          • Henny JA Meijer, Professor doctor
        • Kontakt:

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

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Patient is missing a tooth in the maxillary esthetic region and indicated to be treated with a dental implant and restoration

Beskrivelse

Inclusion Criteria:

  • The patient is 18 years or older;
  • The implant region is an incisor (central or lateral), cuspid or first bicuspid in the maxilla; the adjacent teeth are natural teeth;
  • Sufficient healthy and vital bone after alveolar ridge preservation to insert a dental implant with a minimum length of 10 mm and at least 3.5 mm in diameter with initial stability > 45 Ncm;
  • The implant site must be free from infection;
  • Adequate oral hygiene (modified plaque index and modified sulcus bleeding index ≤ 1);
  • Sufficient mesio-distal, bucco-lingual, and interocclusal space for placement of an anatomic crown;
  • The provisional crown can be designed free from occlusal contact;
  • The patient is capable of understanding and giving informed consent.

Exclusion Criteria:

  • Medical and general contraindications for the surgical procedures;
  • Presence of an active and uncontrolled periodontal disease;
  • Bruxism;
  • Smoking
  • A history of local radiotherapy to the head and neck region.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Printed provisional restoration
Patients with implant placement in the maxillary esthetic region and with immediate placement of a printed provisional restoration.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in peri-implant marginal bone level Description: Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs Time Frame: Through study completion, an average of 1 year
Tidsramme: Through study completion, an average of 1 year
Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs
Through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Implantat- og restaurationsoverlevelse
Tidsramme: Gennem studiefærdiggørelsen, i gennemsnit 1 år
Procentdel af implantater og restaurationer til stede ved opfølgningspunktet
Gennem studiefærdiggørelsen, i gennemsnit 1 år
Patienttilfredshed
Tidsramme: 1 år
Patienttilfredshed målt på en visuel analog skala. Minimum = 0 (yderst utilfreds); Maksimum = 100 (yderst tilfreds).
1 år
Plaquescore
Tidsramme: 1 år
Plaqueindeks fra 0 til 3. Minimum = 0 (ingen plaque synlig); Maksimum = 3 (rigelig mængde plaque synlig)
1 år
Gingivalscore
Tidsramme: 1 år
Sundheden af peri-implantat slimhinde beskrevet ved Gingival indeks fra 0 til 3. Minimum = 0 (sund slimhinde); Maksimum = 3 (meget inficeret slimhinde).
1 år
Lommetykkelse
Tidsramme: 1 år
Probedybde i den peri-implantære sulcus i millimeter målt med en parodontalprobe.
1 år
Bleeding score
Tidsramme: 1 year
Bleeding in peri-implant sulcus after probing measured with a Bleeding index from 0 to 3. Minimum = 0 (no bleeding after probing); Maximum = 3 (abundance amount of bleeding after probing).
1 year

Samarbejdspartnere og efterforskere

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

Sponsor

University Medical Center Groningen

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 (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. juli 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

1. juni 2026

Først opslået (Faktiske)

5. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

5. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

1. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Andre undersøgelses-id-numre

  • Printed provisional crowns

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Betingelser

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