Not_yet_recruitingNANCT07656597

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

Sponsor: Heinrich-Heine University, Duesseldorf

Trial Details

ConditionDental Implant, Implant Therapy, Immediate Dental Implant Placement, Delayed Implant, Guided Surgery Accuracy, Patient-Reported Outcomes (PRO), Single Tooth Dental Implant
InterventionImmediate digital posterior implant workflow; Delayed digital posterior implant workflow
PhaseNA
StatusNot_yet_recruiting
Participants50
Est. Completion31 Oct 2028
Last Updated18 June 2026

Primary Outcome

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).

Eligibility Criteria

Inclusion 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.

Trial Sites

Countries

GermanyHong Kong
View Registry Entry

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