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

15 de junho de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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 de estudo

Intervencional

Inscrição (Estimado)

50

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Alemanha
    • North Rhine-Westphalia
      • Düsseldorf, North Rhine-Westphalia, Alemanha, 40225
        • Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
        • Contato:
        • Investigador principal:
          • PD Dr. Frank Spitznagel, DMD
        • Subinvestigador:
          • Dr. Patrick Klein, DMD
        • Subinvestigador:
          • 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
        • Contato:
          • Prof. Melissa Fok, DMD
          • Número de telefone: +852 2859 0301
          • E-mail: melfok@hku.hk
        • Investigador principal:
          • Prof. Melissa Fok, DMD
        • Subinvestigador:
          • Prof. George Prof. Pelekos, DMD
        • Subinvestigador:
          • Dr. Dominic Ho, DMD

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Nenhum (rótulo aberto)

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: 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.
Procedimento: 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.
Outros nomes:
  • Colocação imediata do implante
  • Type 1C implant placement
  • Immediate digital workflow
  • Immediate posterior implant rehabilitation
Comparador Ativo: 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.
Procedimento: 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.
Outros nomes:
  • Colocação de implante atrasada
  • Type 4B implant placement
  • Delayed digital workflow
  • Delayed posterior implant rehabilitation

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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).
Prazo: 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.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Workflow-Related Patient Experience
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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)

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Heinrich-Heine University, Duesseldorf

Colaboradores

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

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

3 de agosto de 2026

Conclusão Primária (Estimado)

31 de outubro de 2028

Conclusão do estudo (Estimado)

31 de outubro de 2028

Datas de inscrição no estudo

Enviado pela primeira vez

8 de junho de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

15 de junho de 2026

Primeira postagem (Real)

18 de junho de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

18 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Outros números de identificação do estudo

  • 2115-2026 (Número de outro subsídio/financiamento: ITI - International Team for Implantology)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano 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.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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