Clinical Trial

Do Immediate Digital Workflows Increase Patient Value?

Study acronym: ITI PROM RCT
Not Yet Recruiting
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Summary
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.
Trial Details
NCT Number NCT07656597
Lead Sponsor Heinrich-Heine University, Duesseldorf
Collaborators: The University of Hong Kong, ITI International Team for Implantology, Switzerland
Conditions Dental Implant, Implant Therapy, Immediate Dental Implant Placement, Delayed Implant, Guided Surgery Accuracy, Patient-Reported Outcomes (PRO), Single Tooth Dental Implant
Enrollment 50 participants
Start Date 2026-08-03
Primary Completion 2028-10-31 (estimated)
Study Completion 2028-10-31 (estimated)
Updated on ClinicalTrials.gov 2026-06-18