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

15. června 2026 aktualizováno: 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.

Přehled studie

Postavení

Zatím nenabíráme

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Odhadovaný)

50

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

Studijní místa

  • Hongkong
      • Hong Kong, Hongkong
        • The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
        • Kontakt:
          • Prof. Melissa Fok, DMD
          • Telefonní číslo: +852 2859 0301
          • E-mail: melfok@hku.hk
        • Vrchní vyšetřovatel:
          • Prof. Melissa Fok, DMD
        • Dílčí vyšetřovatel:
          • Prof. George Prof. Pelekos, DMD
        • Dílčí vyšetřovatel:
          • Dr. Dominic Ho, DMD
  • Německo
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Německo, 40225
        • Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
        • Kontakt:
        • Vrchní vyšetřovatel:
          • PD Dr. Frank Spitznagel, DMD
        • Dílčí vyšetřovatel:
          • Dr. Patrick Klein, DMD
        • Dílčí vyšetřovatel:
          • Prof. Dr. Petra Gierthmühlen, DMD

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: 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.
Postup: 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.
Ostatní jména:
  • Okamžité zavedení implantátu
  • Type 1C implant placement
  • Immediate digital workflow
  • Immediate posterior implant rehabilitation
Aktivní komparátor: 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.
Postup: 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.
Ostatní jména:
  • Zpožděné zavedení implantátu
  • Type 4B implant placement
  • Delayed digital workflow
  • Delayed posterior implant rehabilitation

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
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).
Časové okno: 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.

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Workflow-Related Patient Experience
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Heinrich-Heine University, Duesseldorf

Spolupracovníci

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

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Odhadovaný)

3. srpna 2026

Primární dokončení (Odhadovaný)

31. října 2028

Dokončení studie (Odhadovaný)

31. října 2028

Termíny zápisu do studia

První předloženo

8. června 2026

První předloženo, které splnilo kritéria kontroly kvality

15. června 2026

První zveřejněno (Aktuální)

18. června 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

18. června 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

15. června 2026

Naposledy ověřeno

1. června 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • 2115-2026 (Jiné číslo grantu/financování: ITI - International Team for Implantology)

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu 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.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

produkt vyrobený a vyvážený z USA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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