Клиническое исследование имплантатов с технологией TiUltra и соответствующих ортопедических компонентов
Проспективное неинтервенционное клиническое исследование для оценки безопасности, производительности и клинических преимуществ имплантатов с технологией TiUltra и соответствующих ортопедических компонентов
This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The primary aim of this study is to demonstrate non-inferiority of all NobelBiocare TiUltra implants to historic data from NobelActive TiUnite coated implant in terms of marginal bone level change over 5 years after final prosthetic delivery. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement
Обзор исследования
Статус
Подробное описание
Primary Objective: The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit.
Secondary Objective:The secondary objectives of this clinical investigation are:
- To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits
- To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit
- To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit
- To evaluate soft tissue outcome (as measured by bleeding index, plaque index and gingival index) to 5 years from definitive prosthetic placement.
- To evaluate SADE, USADE, ADE and DD from implant insertion until 5 years follow-up visit.
Study design: This is a multicenter, prospective, non-interventional study in which a total of 1000 subjects in need of a single, multiple or full arch restoration in any region of the mouth (healed or extracted) will be treated in up to 30 study centers. The study devices are divided into four groups:
- Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
- Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
- Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
- Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)
Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria. Eligible subjects who provide their informed consent for participation will be enrolled into one of four groups, each sized to 250 individuals. They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement . Possible dropouts and withdrawals, as well as possible serious adverse (device) events, will be carefully monitored during the entire study period
Sequence of treatment: As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study. Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject. Standard of care follow-up visits should be scheduled as close as possible to 1-, 3- and 5- years after definitive prosthetic placement, to ascertain a homogenous data set. Deidentified periapical radiographs from each subject visit shall be uploaded to the study eCRF. All images will be forwarded to the core lab for independent analysis. As part of the screening process each subject will undergo a pre-treatment standard of care examination to record demographic characteristics and medical history. The subjects will be informed of the treatment possibilities according to clinic standard of care and about the study.
Depending on the clinical indication, clinician preferences and desired esthetic solution the subject will be enrolled into one of the four previously described groups (G1 to G4). Implant surgery-, bone and tissue regenerative- and prosthodontic procedures shall be performed according to IFU and standard of care. Implants may be placed in either healed or extraction sites utilizing one-stage or two-stage surgical protocol with immediate, early or delayed loading to restore single missing tooth, partial or fully edentulous jaws. The treating clinician should decide individually when definitive prosthesis installation is suitable for each subject.
Study duration: Once the subject has provided written informed consent and fulfilled all inclusion and none of the exclusion criteria, he/she is considered enrolled. Subject enrolment period is expected to take 7 months from time of initiation at each site. Enrolment in each group will stop once the total group size of 250 subjects has been met. The clinical investigation will continue until each subject has been followed for 5-years after final prosthetic delivery.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
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Melbourne, Австралия, 3010
- Melbourne Dental School The University of Melbourne
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New South Wales
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Pyrmont, New South Wales, Австралия, 2009
- Dentartisans Pty ltd
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Perth
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West Perth, Perth, Австралия, 6005
- Bc Prosthodontics
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Vienna, Австрия, 1190
- Implantologie und Ästhetische Zahnheilkunde
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Vienna, Австрия, 1090
- Akademie für orale Implantologie GmbH & Co
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Karlstadt am Main, Германия, 97753
- DrS - Schöne Zähne - Dr. Scherg Praxis für Implantologie & Ästhetik
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Herning
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Herning, Herning, Дания, 7400
- Herning Implantat Center
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Barcelona, Испания, 08006
- Clinica Lluch
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Málaga, Испания, 29016
- Clinica Dental Crooke & Laguna
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Palma de Mallorca, Испания, 07004
- Altés & Mesquida
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Cattolica, Италия, 47841
- Studio Odontoiatrico Specialistico Ban Mancini Fabbri
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Verona, Италия, 37134
- UOC di Chirurgia Maxillo-Facciale e Odontoiatria
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's-Hertogenbosch, Нидерланды, 5216
- Staas & Bergmans Zorgvooruwmond B.V.
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Breda, Нидерланды, 4819
- ParoBrea- Parodontologie & Implantologie
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Groningen, Нидерланды, 9713
- Department of Oral and Maxillofacial Surgery University Medical Center Groningen
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Harstad, Норвегия, 9405
- The Oris Dental Harstad
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Lisbon, Португалия, 1600-042
- Maló Clinic
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Alabama
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Madison, Alabama, Соединенные Штаты, 35758
- Madison Prosthodontics
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Illinois
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Arlington Heights, Illinois, Соединенные Штаты, 60005
- Northwest Oral and Maxillofacial Surgery
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Saint Charles, Illinois, Соединенные Штаты, 60174
- Midwest Dental Implantology
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New York
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New York, New York, Соединенные Штаты, 10022
- New York Center for Orthognathic and Maxillofacial Surgery
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Oregon
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Tualatin, Oregon, Соединенные Штаты, 97062
- Periodontal Associates
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Tampere, Финляндия, 33200
- Dental Center Helmiäinen
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Lyon, Франция, 69002
- Cabinet du Dr Noharet
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Montpellier, Франция, 34090
- BGLP
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Paris, Франция, 75017
- IFCIA
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Egerkingen, Швейцария, 4622
- Dentalspecialist
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Lucerne, Швейцария, 6003
- Brunner Praxis für Zahnmedizin
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Oberrieden, Швейцария, 8942
- Centrella Zahnärzte
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Rorschach, Швейцария, 9400
- Bodensee-Implantat-Zentrum AG
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Gothenburg, Швеция, 413 90
- Folktandvården Västra Götaland, Brånemarkkliniken
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Malmö, Швеция, 217 72
- Pequrio AB
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Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Subjects will be consecutively included provided they meet all of the inclusion criteria and none of the exclusion criteria.They will be treated with the corresponding implant system assigned to the group. The allocation into a certain group is only driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. Each subject will be followed for 5 years after definitive prosthetic placement.
If the subject wishes to withdraw from the clinical study, he/she may do so at any time and for any reason during the clinical study. If provided, the reason for withdrawal should be recorded and documented in the subject's medical record and in the eCRF.
Описание
Inclusion Criteria:
- Subject signed the informed consent
- Subject is between 18 and 70 years of age
- Subjects presented with the need of single, multiple or full arch implant rehabilitation in any region of the mouth.
- Subject with medical and anatomical conditions that are in accordance with the applicable instructions for use (IFU).
- Subject with sufficient bone volume for implant placement.
- Subject is compliant with good oral hygiene as judged by the clinician.
Exclusion Criteria:
- Anatomical conditions discovered during surgery preventing the use of intended implant system.
- Subjects with history of allergy or adverse reactions to any materials used
- Uncontrolled diabetes (subjects with history of diabetes mismanagement and/or known A1c level above 8%)*
- Heavy smokers (>10 cigarettes per day)
- Severe bruxism or dysfunctional tendencies
- Previous oro-maxillo facial radiotheraphy
- Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc)
- Any disorders in the planned implant area such as previous tumors, chronic bone disease or previous radiation.
- Acute, untreated periodontitis in the planned implantation site or adjacent tissue.
- Infections in the planned implantation site or adjacent tissue.
- Documented complete remission of >3 years if history of non-oral cancer.
- Pregnant or lactating women at the time of implant insertion. *Assessment of A1C level is not required unless it is standard of care at the treating clinic
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: OTHER
- Временные перспективы: PROSPECTIVE
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
Group 1 (G1): NobelActive TiUltra implants (3.0, NP, RP, WP)
Subjects will be enrolled into Group 1 and treated with NobelActive TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. |
|
Group 2 (G2): NobelParallel CC TiUltra implants (NP, RP; WP)
Subjects will be enrolled into Group 1 and treated with NobelParallel CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. |
|
Group 3 (G3): NobelReplace CC TiUltra implants (NP, RP)
Subjects will be enrolled into Group 1 and treated with NobelReplace CC TiUltra implants, only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. |
|
Group 4 (G4): Nobel Biocare N1 TiUltra TCC implants (NP, RP)
Subjects will be enrolled into Group 1 and treated with Nobel Biocare N1 TiUltra TCC implants , only if it is driven by the subject's clinical and restorative requirement and standard of care at the enrolling study clinic. |
Subjects will be enrolled and treated with one of the above groups as per the their clinical requirement and standard of care of the clinic. |
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Marginal bone level change
Временное ограничение: Definitive prosthetic delivery to 5-years follow-up
|
The primary endpoint is to evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to the 5-year follow-up visit. |
Definitive prosthetic delivery to 5-years follow-up
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Marginal bone level change
Временное ограничение: Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
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To evaluate the change in the marginal bone level from definitive prosthetic placement (baseline) to 1-year and 3-years follow-up visits |
Definitive Prosthetic delivery to 1-year, Definitive Prosthetic delivery to 3-years
|
|
Cumulative Survival rate/Cumulative success rate
Временное ограничение: Definitive prosthetic delivery to 5-year follow-up
|
To demonstrate cumulative implant survival and success rates from definitive prosthetic placement to 5 years follow-up visit |
Definitive prosthetic delivery to 5-year follow-up
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|
Prsothetic suviival and success rate
Временное ограничение: Definitive prosthetic delivery to 5-years follow-up
|
To demonstrate cumulative prosthetic survival and success rates to 5 years follow-up visit |
Definitive prosthetic delivery to 5-years follow-up
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Sost tissue outcome- Bleeding index
Временное ограничение: Definitive prosthetic delivery to 5-years follow-up
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To evaluate soft tissue outcome as measured by bleeding index from definitive prosthetic placement to 5 years follow-up visit |
Definitive prosthetic delivery to 5-years follow-up
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Sost tissue outcome- Plaque index
Временное ограничение: Definitive prosthetic delivery to 5-years follow-up
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To evaluate soft tissue outcome as measured by plaque index from definitive prosthetic placement to 5 years follow-up visit. |
Definitive prosthetic delivery to 5-years follow-up
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Sost tissue outcome- Ginigval index
Временное ограничение: Definitive prosthetic delivery to 5-years follow-up
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To evaluate soft tissue outcome as measured by gingival index from definitive prosthetic placement to 5 years follow-up visit |
Definitive prosthetic delivery to 5-years follow-up
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Adverse event
Временное ограничение: Implant insertion to 5-years follow-up
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To evaluate Serious Adverse Device Effects , Unanticipated Serious Adverse Device Effect , Adverse Device Effects and Device Deficiency from implant insertion until 5 years follow-up visit. |
Implant insertion to 5-years follow-up
|
Соавторы и исследователи
Спонсор
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Другие идентификационные номера исследования
- T-192
Планирование данных отдельных участников (IPD)
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Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
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. .