Do Immediate Digital Workflows Increase Patient Value? (ITI PROM RCT)
15 juin 2026 mis à jour par: 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.
Aperçu de l'étude
Statut
Pas encore de recrutement
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Estimé)
50
Phase
- N'est pas applicable
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: PD Dr. Frank Spitznagel, DMD
- Numéro de téléphone: +49-211-81-04440
- E-mail: frank.spitznagel@med.uni-duesseldorf.de
Lieux d'étude
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Allemagne, 40225
- Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
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Contact:
- PD Dr. Frank Spitznagel, DMD, PhD
- Numéro de téléphone: +49-211-81-04440
- E-mail: frank.spitznagel@med.uni-duesseldorf.de
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Chercheur principal:
- PD Dr. Frank Spitznagel, DMD
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Sous-enquêteur:
- Dr. Patrick Klein, DMD
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Sous-enquêteur:
- Prof. Dr. Petra Gierthmühlen, DMD
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Hong Kong, Hong Kong
- The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
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Contact:
- Prof. Melissa Fok, DMD
- Numéro de téléphone: +852 2859 0301
- E-mail: melfok@hku.hk
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Chercheur principal:
- Prof. Melissa Fok, DMD
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Sous-enquêteur:
- Prof. George Prof. Pelekos, DMD
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Sous-enquêteur:
- Dr. Dominic Ho, DMD
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Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Non
La description
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.
Plan d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Aucun (étiquette ouverte)
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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.
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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.
Autres noms:
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Comparateur actif: 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.
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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.
Autres noms:
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Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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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).
Délai: 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.
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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.
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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.
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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Workflow-Related Patient Experience
Délai: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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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.
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Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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Workflow Efficiency
Délai: Visit 1-4 (0 months - up to 4-6 months).
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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).
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Visit 1-4 (0 months - up to 4-6 months).
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Buccal Contour Changes
Délai: 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)
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Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading
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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)
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Radiographic Outcomes
Délai: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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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.
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Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinical Soft Tissue Outcomes 1
Délai: 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)
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Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)
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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)
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Clinical Soft Tissue Outcome 2
Délai: 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)
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Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)
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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)
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Implant/prosthetic outcomes
Délai: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.
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Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Pink and White Esthetics
Délai: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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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:
WES:
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)
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Clinician-reported outcomes
Délai: 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)
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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)
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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)
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Implant Accuracy
Délai: Visit 3 (+0-4 months)
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Implant Placement Accuracy.
Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).
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Visit 3 (+0-4 months)
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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Estimé)
3 août 2026
Achèvement primaire (Estimé)
31 octobre 2028
Achèvement de l'étude (Estimé)
31 octobre 2028
Dates d'inscription aux études
Première soumission
8 juin 2026
Première soumission répondant aux critères de contrôle qualité
15 juin 2026
Première publication (Réel)
18 juin 2026
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
18 juin 2026
Dernière mise à jour soumise répondant aux critères de contrôle qualité
15 juin 2026
Dernière vérification
1 juin 2026
Plus d'information
Termes liés à cette étude
Mots clés
Autres numéros d'identification d'étude
- 2115-2026 (Autre subvention/numéro de financement: ITI - International Team for Implantology)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Description du régime 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.
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
produit fabriqué et exporté des États-Unis.
Non
Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .