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NCT07656597
Do Immediate Digital Workflows Increase Patient Value?
Conditions: Dental Implant, Implant Therapy, Immediate Dental Implant Placement, Delayed Implant, Guided Surgery Accuracy, Patient-Reported Outcomes (PRO), Single Tooth Dental Implant
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 50
Sponsor: Heinrich-Heine University, Duesseldorf
Location: Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany Düsseldorf North Rhine-Westphalia
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.
Eligibility Criteria
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.
Source: ClinicalTrials.gov (NCT07656597). StuddyBuddy aggregates publicly available trial information.