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NOT YET RECRUITING
NCT07656597
NA

Do Immediate Digital Workflows Increase Patient Value?

Sponsor: Heinrich-Heine University, Duesseldorf

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

50

Start Date

2026-08-03

Completion Date

2028-10-31

Last Updated

2026-06-18

Healthy Volunteers

No

Interventions

PROCEDURE

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.

PROCEDURE

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.

Locations (2)

Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany

Düsseldorf, North Rhine-Westphalia, Germany

The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital

Hong Kong, Hong Kong