- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT07629752
Immediate Loading of Implants in the Aesthetic Zone Using Three-dimensionally Printed Provisional Crowns: a 1-year Prospective Case Series Study
• 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)
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
• 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.
Tipo di studio
Iscrizione (Stimato)
Contatti e Sedi
Contatto studio
- Nome: Henny J A Meijer, Professor doctor
- Numero di telefono: +31503616161
- Email: h.j.a.meijer@umcg.nl
Luoghi di studio
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Provincie Groningen
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Groningen, Provincie Groningen, Olanda, 9700RB
- University Medical Center Groningen
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Investigatore principale:
- Henny JA Meijer, Professor doctor
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Contatto:
- Henny J A Meijer, Professor doctor
- Numero di telefono: +31503616161
- Email: h.j.a.meijer@umcg.nl
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Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
Metodo di campionamento
Popolazione di studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
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Printed provisional restoration
Patients with implant placement in the maxillary esthetic region and with immediate placement of a printed provisional restoration.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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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
Lasso di tempo: Through study completion, an average of 1 year
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Comparison between peri-implant bone level at implant placement and follow-up time point in millimeters measured on intraoral radiographs
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Through study completion, an average of 1 year
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Sopravvivenza dell'impianto e della protesi
Lasso di tempo: Fino al completamento dello studio, in media 1 anno
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Percentuale di impianti e restauri presenti al momento del follow-up
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Fino al completamento dello studio, in media 1 anno
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Soddisfazione del paziente
Lasso di tempo: 1 anno
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Soddisfazione del paziente misurata su una Scala Analogica Visiva.
Minimo = 0 (estremamente insoddisfatto); Massimo = 100 (estremamente soddisfatto).
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1 anno
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Punteggio della placca
Lasso di tempo: 1 anno
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Indice di placca da 0 a 3. Minimo = 0 (nessuna placca visibile); Massimo = 3 (quantità abbondante di placca visibile)
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1 anno
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Punteggio gengivale
Lasso di tempo: 1 anno
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Salute della mucosa peri-implantare descritta dall'indice gengivale da 0 a 3. Minimo = 0 (mucosa sana); Massimo = 3 (mucosa molto infetta).
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1 anno
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Profondità della tasca
Lasso di tempo: 1 anno
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Profondità di sondaggio nel solco peri-implantare in millimetri misurata con una sonda parodontale.
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1 anno
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Bleeding score
Lasso di tempo: 1 year
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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).
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1 year
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Collaboratori e investigatori
Studiare le date dei record
Studia le date principali
Inizio studio (Stimato)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- Printed provisional crowns
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Prove cliniche su Impianti dentali, dente singolo
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Cairo UniversitySconosciutoBlack Stain Dental, Dental Black Stain, Black Stain*, Black Stain, Tooth Stains