Do Immediate Digital Workflows Increase Patient Value? (ITI PROM RCT)
15 июня 2026 г. обновлено: Heinrich-Heine University, Duesseldorf
Do Immediate Digital Workflows Increase Patient Value? A Patient-Reported Outcome Measure-Based Randomized Controlled Trial Comparing Immediate Versus Delayed Digital Posterior Implant Workflows
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.
Обзор исследования
Статус
Еще не набирают
Условия
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.
Тип исследования
Интервенционный
Регистрация (Оцененный)
50
Фаза
- Непригодный
Контакты и местонахождение
В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.
Контакты исследования
- Имя: PD Dr. Frank Spitznagel, DMD
- Номер телефона: +49-211-81-04440
- Электронная почта: frank.spitznagel@med.uni-duesseldorf.de
Места учебы
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North Rhine-Westphalia
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Düsseldorf, North Rhine-Westphalia, Германия, 40225
- Department of Prosthodontics, Medical Faculty and University Hospital Düsseldorf, Heinrich-Heine-University Düsseldorf, Moorenstraße 5, 40225 Düsseldorf, Germany
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Контакт:
- PD Dr. Frank Spitznagel, DMD, PhD
- Номер телефона: +49-211-81-04440
- Электронная почта: frank.spitznagel@med.uni-duesseldorf.de
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Главный следователь:
- PD Dr. Frank Spitznagel, DMD
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Младший исследователь:
- Dr. Patrick Klein, DMD
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Младший исследователь:
- Prof. Dr. Petra Gierthmühlen, DMD
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Hong Kong, Гонконг
- The University of Hong Kong Department of Periodontology and Implant Dentistry, Faculty of Dentistry Prince Philip Dental Hospital
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Контакт:
- Prof. Melissa Fok, DMD
- Номер телефона: +852 2859 0301
- Электронная почта: melfok@hku.hk
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Главный следователь:
- Prof. Melissa Fok, DMD
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Младший исследователь:
- Prof. George Prof. Pelekos, DMD
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Младший исследователь:
- Dr. Dominic Ho, DMD
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Критерии участия
Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.
Критерии приемлемости
Возраст, подходящий для обучения
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Нет
Описание
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.
Учебный план
В этом разделе представлена подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.
Как устроено исследование?
Детали дизайна
- Основная цель: Уход
- Распределение: Рандомизированный
- Интервенционная модель: Параллельное назначение
- Маскировка: Нет (открытая этикетка)
Оружие и интервенции
Группа участников / Армия |
Вмешательство/лечение |
|---|---|
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Экспериментальный: Immediate Digital Workflow / Immediate Implant Placement (Type 1C)
Atraumatic tooth extraction and guided implant placement during the same surgical session.
Socket management follows the standardized protocol according to defect morphology.
Implants are sealed without functional loading and restored with a definitive screw-retained monolithic zirconia crown after healing.
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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.
Другие имена:
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Активный компаратор: Delayed Digital Workflow / Delayed Implant Placement (Type 4B)
Tooth extraction with alveolar ridge preservation as required.
Implant placement is performed after approximately 16 weeks of healing using the same surgical and prosthetic protocol.
Definitive restoration is delivered after healing following implant placement.
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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.
Другие имена:
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Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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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).
Временное ограничение: 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.
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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.
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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.
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Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
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Workflow-Related Patient Experience
Временное ограничение: Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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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.
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Crown delivery (Baseline loading 0 months) and 12-months follow-up post loading
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Workflow Efficiency
Временное ограничение: Visit 1-4 (0 months - up to 4-6 months).
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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).
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Visit 1-4 (0 months - up to 4-6 months).
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Buccal Contour Changes
Временное ограничение: 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)
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Volumetric region-of-interest shrinkage / contour change derived from serial intraoral scans at protocol-defined visits through from baseline till 12 months after loading
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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)
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Radiographic Outcomes
Временное ограничение: Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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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.
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Visit 3 (+0-4 months), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinical Soft Tissue Outcomes 1
Временное ограничение: 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)
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Mid-buccal mucosal level (in mm), keratinized mucosa width (in mm), probing pocket depth (in mm), recession/dehiscence (in mm)
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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)
|
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Clinical Soft Tissue Outcome 2
Временное ограничение: 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)
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Bleeding on probing (in % number of bleeding surfaces/total number of surfaces), Plaque index (in % number of bleeding surfaces/total number of surfaces)
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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)
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Implant/prosthetic outcomes
Временное ограничение: Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Implant survival at 6 and 12 months post-loading; technical complications; prosthetic success according to modified United States Public Health (USPHS) criteria.
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Visit 5 (+4-5 months from Baseline), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Pink and White Esthetics
Временное ограничение: Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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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:
WES:
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 |
Visit 1 (Baseline), Visit 5 (+4-5 months), Visit 6 (+ 6 Months after loading), Visit 7 (+12 Months after loading)
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Clinician-reported outcomes
Временное ограничение: 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)
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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)
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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)
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Implant Accuracy
Временное ограничение: Visit 3 (+0-4 months)
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Implant Placement Accuracy.
Planned versus actual implant position including angulation (in degrees), platform deviation (in mm), and apex deviation (in mm).
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Visit 3 (+0-4 months)
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Соавторы и исследователи
Здесь вы найдете людей и организации, участвующие в этом исследовании.
Даты записи исследования
Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.
Изучение основных дат
Начало исследования (Оцененный)
3 августа 2026 г.
Первичное завершение (Оцененный)
31 октября 2028 г.
Завершение исследования (Оцененный)
31 октября 2028 г.
Даты регистрации исследования
Первый отправленный
8 июня 2026 г.
Впервые представлено, что соответствует критериям контроля качества
15 июня 2026 г.
Первый опубликованный (Действительный)
18 июня 2026 г.
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
18 июня 2026 г.
Последнее отправленное обновление, отвечающее критериям контроля качества
15 июня 2026 г.
Последняя проверка
1 июня 2026 г.
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- 2115-2026 (Другой номер гранта/финансирования: ITI - International Team for Implantology)
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
НЕТ
Описание плана IPD
Individual participant data will not be made publicly available due to data protection and ethical restrictions.
Aggregated study results will be disseminated through peer-reviewed publication.
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Нет
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
Нет
продукт, произведенный в США и экспортированный из США.
Нет
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .