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Do Immediate Digital Workflows Increase Patient Value? (ITI PROM RCT)

15 giugno 2026 aggiornato da: Heinrich-Heine University, Duesseldorf

Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows

This two-center randomized controlled trial will evaluate whether an immediate digital posterior implant workflow provides greater patient-defined value than a delayed digital workflow in adults requiring single posterior implant rehabilitation. Participants will be randomized 1:1 to immediate implant placement at the time of tooth extraction or to delayed implant placement after approximately 16 weeks of healing following extraction and ridge preservation as indicated. The primary endpoint is oral health-related quality of life assessed longitudinally using the OHIP-14 questionnaire and analyzed as the model-based mean score averaged across the active treatment phase from baseline through definitive crown delivery. Secondary outcomes include workflow-related patient experience, chairside time, number of visits, postoperative pain, buccal contour changes based on intraoral scan-derived volumetric analysis, radiographic marginal bone level changes, implant survival, clinical peri-implant parameters, technical complications, esthetic outcomes, accuracy of guided implant placement, and clinician-reported workflow outcomes.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

Digital implant workflows enable guided surgery, intraoral scanning, and standardized restorative components, and may reduce treatment burden while supporting efficient, patient-centered care. In posterior single-tooth implant rehabilitation, immediate and delayed placement protocols have been extensively evaluated from a biological perspective, but evidence on patient-reported oral health-related quality of life and workflow efficiency remains limited.

The study compares two standardized digital posterior implant rehabilitation pathways that differ in implant placement timing: immediate placement (Type 1C) versus delayed placement (Type 4B). Participants requiring extraction and single implant therapy in posterior premolar or molar sites will be enrolled at two geographically distinct centers. The immediate workflow combines atraumatic extraction and guided implant placement in one surgical session. The delayed workflow includes extraction and ridge preservation as indicated, followed by implant placement after approximately 16 weeks of healing. Both groups will receive guided implant placement with Straumann BLC implants and a screw-retained monolithic zirconia crown according to the protocol.

The primary objective is to compare the overall treatment-related impact on oral health-related quality of life during the active treatment phase using OHIP-14. Key secondary objectives are to compare workflow-related patient experience, objective workflow efficiency, and peri-implant soft tissue contour changes, while monitoring clinical, radiographic, esthetic, implant-related, and prosthetic safety outcomes.

Tipo di studio

Interventistico

Iscrizione (Stimato)

50

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Germania
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Germania, 40225
        • Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
        • Contatto:
        • Investigatore principale:
          • PD Dr. Frank Spitznagel, DMD
        • Sub-investigatore:
          • Dr. Patrick Klein, DMD
        • Sub-investigatore:
          • Prof. Dr. Petra Gierthmühlen, DMD
  • Hong Kong
      • Hong Kong, Hong Kong
        • The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
        • Contatto:
          • Prof. Melissa Fok, DMD
          • Numero di telefono: +852 2859 0301
          • Email: melfok@hku.hk
        • Investigatore principale:
          • Prof. Melissa Fok, DMD
        • Sub-investigatore:
          • Prof. George Prof. Pelekos, DMD
        • Sub-investigatore:
          • Dr. Dominic Ho, DMD

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

Inclusion Criteria:

  • Adults aged 18 years or older.
  • Indication for single implant therapy in a posterior premolar or molar extraction site.
  • Good oral hygiene with FMPS ≤20%.
  • Controlled periodontitis according to protocol definition.
  • At least one natural tooth adjacent to the implant site and presence of an antagonist tooth.
  • Ability to comply with study procedures and provide written informed consent.
  • Adequate bone volume for immediate or delayed placement.
  • Extraction site suitable for centrally positioned, prosthetically driven implant placement using straight prosthetic components.
  • Ability to achieve 3-4 mm circumferential implant engagement in native bone along the planned implant axis while maintaining safety distance from vital structures.
  • For molar sites, septal bone classified as Smith & Tarnow Type A or Type B, including cases requiring closed sinus floor elevation.
  • Post-extraction socket presenting as a contained or partially contained defect with at least three relatively intact socket walls and no individual socket wall vertical defect >5 mm.
  • No facial soft-tissue dehiscence or mucogingival defect associated with buccal bone dehiscence.

Exclusion Criteria:

  • • Known or suspected poor compliance, alcohol abuse, or substance abuse.

    • Systemic or local contraindications to implant surgery.
    • History of head/neck radiotherapy or recent malignancy within 5 years.
    • Use of medications affecting bone metabolism.
    • Bisphosphonate use within the past 5 years.
    • Uncontrolled periodontal disease.
    • Heavy smoking (>10 cigarettes/day).
    • Pregnancy or lactation.
    • Teeth with periapical lesions >5 mm in greatest diameter, or sockets demonstrating a large cortical perforation >5 mm in greatest dimension on CBCT.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Immediate Digital Workflow / Immediate Implant Placement (Type 1C)
Atraumatic tooth extraction and guided implant placement during the same surgical session. Socket management follows the standardized protocol according to defect morphology. Implants are sealed without functional loading and restored with a definitive screw-retained monolithic zirconia crown after healing.
Procedura: Immediate digital posterior implant workflow
Participants allocated to the immediate digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by immediate implant placement during the same surgical session. Implant placement will be performed using a prosthetically driven digital workflow with static guided surgery. Socket management and sealing of the extraction socket will be performed according to the standardized study protocol and local standard of care. Definitive prosthetic restoration will be delivered after the planned healing period.
Altri nomi:
  • Posizionamento immediato dell'impianto
  • Type 1C implant placement
  • Immediate digital workflow
  • Immediate posterior implant rehabilitation
Comparatore attivo: Delayed Digital Workflow / Delayed Implant Placement (Type 4B)
Tooth extraction with alveolar ridge preservation as required. Implant placement is performed after approximately 16 weeks of healing using the same surgical and prosthetic protocol. Definitive restoration is delivered after healing following implant placement.
Procedura: Delayed digital posterior implant workflow
Participants allocated to the delayed digital workflow will undergo atraumatic extraction of a non-restorable posterior tooth followed by alveolar ridge preservation as indicated according to the standardized study protocol and local standard of care. Implant placement will be performed after approximately 16 weeks of healing using a prosthetically driven digital workflow with static guided surgery. Definitive prosthetic restoration will be delivered after the planned healing period.
Altri nomi:
  • Inserimento ritardato dell'impianto
  • Type 4B implant placement
  • Delayed digital workflow
  • Delayed posterior implant rehabilitation

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Oral health-related quality of life (OHIP) assessed with OHIP-14 Questionnaire: model-based mean OHIP-14 score averaged across the active treatment phase (0-4 months).
Lasso di tempo: Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.
The primary estimand is the between-group difference in model-based least-squares mean OHIP-14 scores (0-4) averaged across the active treatment phase. Lower OHIP-14 scores indicate lower treatment-related impact / better oral health-related quality of life.
Baseline / enrollment (0 months), 7 days after surgical intervention(s), and definitive crown delivery (approximately 4 months); approximately baseline (0 months) through 4-6 months depending on allocation.

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Workflow-Related Patient Experience
Lasso di tempo: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
Overall treatment experience assessed using a Visual Analogue Scale (VAS 0-100) at crown delivery and at 12-months follow-up. Higher scores indicate greater perceived treatment experience and perceived value of the treatment pathway.
Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
Workflow Efficiency
Lasso di tempo: Visit 1-4 (0 months - up to 4-6 months).
Chairside time (in minutes) per visit and cumulative chairside time (in minutes) from enrollment through crown delivery (Visit 1-4); number of visits and unplanned interventions (measured in time per minutes).
Visit 1-4 (0 months - up to 4-6 months).
Buccal Contour Changes
Lasso di tempo: Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading
Visit 1 (Baseline), Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Radiographic Outcomes
Lasso di tempo: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Marginal bone level changes at implant placement, loading, +6 months, and +12 months post loading (measured in mm); proportion of implants with >1 mm or >2 mm marginal bone loss.
Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcomes 1
Lasso di tempo: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)
Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinical Soft Tissue Outcome 2
Lasso di tempo: Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)
Visit 1 (Baseline), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant/prosthetic outcomes
Lasso di tempo: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.
Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Pink and White Esthetics
Lasso di tempo: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)

Pink Esthetic Score/ White Esthetic Score (PES/WES);

The PES and WES scores allow an objective evaluation of the aesthetics of implant supported single crowns and adjacent soft tissues based on five parameters:

PES:

  • Mesial papilla
  • Distal papilla
  • Curvature of facial mucosa
  • Level of facial mucosa
  • Root convexity/ soft tissue colour and texture

WES:

  • Tooth form
  • Outline and volume of the clinical crown
  • Colour, which includes the assessment of the dimension's hue and value
  • Surface texture
  • Translucency and characterization

Each variable will be assessed using a 0-1-2 scoring system; 0 being the lowest, and 2 being the highest value. Hence, the highest possible PES and WES score is 10 each, whereas the highest possible combined PES/WES score is 20
Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Clinician-reported outcomes
Lasso di tempo: Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)

Procedural difficulty and workflow perception assessed using a numeric rating scale (NRS, 0-10) at extraction and implant placement (0 = extremely easy, 10 = extremely difficult)

  • Clinician satisfaction with treatment workflow and outcome assessed at crown delivery and 12 months (0 = extremely dissatisfied, 10 = extremely satisfied)
  • Clinician stress level during surgery (extraction and implant placement) measuring physiological stress (assessed by heart rate) and psychological stress and workload (assessed by two questionnaires: short-form State-Trait Anxiety Inventory (STAI-6) and the Surgery Task Load Index (SURG-TLX)
Visit 2 (+ 2-4 weeks), Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
Implant Accuracy
Lasso di tempo: Visit 3 (+0-4 months)
Implant Placement Accuracy. Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).
Visit 3 (+0-4 months)

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Heinrich-Heine University, Duesseldorf

Collaboratori

The University of Hong Kong
ITI International Team for Implantology, Switzerland

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

3 agosto 2026

Completamento primario (Stimato)

31 ottobre 2028

Completamento dello studio (Stimato)

31 ottobre 2028

Date di iscrizione allo studio

Primo inviato

8 giugno 2026

Primo inviato che soddisfa i criteri di controllo qualità

15 giugno 2026

Primo Inserito (Effettivo)

18 giugno 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

18 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

15 giugno 2026

Ultimo verificato

1 giugno 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Altri numeri di identificazione dello studio

  • 2115-2026 (Altro numero di sovvenzione/finanziamento: ITI - International Team for Implantology)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

Individual participant data will not be made publicly available due to data protection and ethical restrictions. Aggregated study results will be disseminated through peer-reviewed publication.

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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