Do Immediate Digital Workflows Increase Patient Value?

N/ANot Yet RecruitingNCT07656597

Heinrich-Heine University, Duesseldorf50 enrolled

Overview

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.

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.

Interventions

Immediate digital posterior implant workflowPROCEDURE

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.

Delayed digital posterior implant workflowPROCEDURE

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Outcomes

Primary Outcomes

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).

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.

Time frame: 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.

Secondary Outcomes

Workflow-Related Patient Experience

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.

Time frame: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading

Workflow Efficiency

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).

Time frame: Visit 1-4 (0 months - up to 4-6 months).

Buccal Contour Changes

Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading

Time frame: 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)

Radiographic Outcomes

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.

Time frame: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)

Clinical Soft Tissue Outcomes 1

Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)

Time frame: 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)

Clinical Soft Tissue Outcome 2

Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)

Time frame: 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)

Implant/prosthetic outcomes

Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.

Time frame: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)

Pink and White Esthetics

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: * Mesial papilla * Distal papilla * Curvature of facial mucosa * Level of facial mucosa * Root convexity/ soft tissue colour and texture WES: * Tooth form * Outline and volume of the clinical crown * Colour, which includes the assessment of the dimension's hue and value * Surface texture * Translucency and characterization 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

Time frame: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)

Clinician-reported outcomes

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) * Clinician satisfaction with treatment workflow and outcome assessed at crown delivery and 12 months (0 = extremely dissatisfied, 10 = extremely satisfied) * Clinician stress level during surgery (extraction and implant placement) measuring physiological stress (assessed by heart rate) and psychological stress and workload (assessed by two questionnaires: short-form State-Trait Anxiety Inventory (STAI-6) and the Surgery Task Load Index (SURG-TLX)

Time frame: 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)

Implant Accuracy

Implant Placement Accuracy. Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).

Time frame: Visit 3 (+0-4 months)