Do Immediate Digital Workflows Increase Patient Value?

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Процедура 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
• Процедура 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.

Первичные конечные точки

• 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). [Срок оценки: 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.]

Вторичные конечные точки (10)

• Workflow-Related Patient Experience [Срок оценки: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading]
• Workflow Efficiency [Срок оценки: Visit 1-4 (0 months - up to 4-6 months).]
• Buccal Contour Changes [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: 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 [Срок оценки: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)]
• Pink and White Esthetics [Срок оценки: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)]
• Clinician-reported outcomes [Срок оценки: 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 [Срок оценки: Visit 3 (+0-4 months)]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• • 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Германия · 1 центр

• Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich — Düsseldorf

Гонконг · 1 центр

• The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of — Гонконг

Идентификаторы

NCT: NCT07656597 · 2115-2026 · 2115-2026

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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