Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

Официальное название

Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.

Обзор

This investigation is a pre-market, prospective, multi-center, randomized, single blinded, parallel controlled clinical investigation performed in at least 5 clinical centers for confirmatory purposes of the use of WHA as intended in the filling of extraction sockets to enhance preservation of the alveolar socket.

Подробное описание

In this study, the subjects will be pseudonymized and randomized in a 1:1 ratio between WHA and the selected comparator device Bio-Oss®. The sample size of the study has been computed based on a non-inferiority test between Bio- Oss® and WHA for device performance for the filling of extraction sockets. A total of 96 subjects will be enrolled.

The results will be used to demonstrate the safety, performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017/745.

The endpoints are all accurately based on objective measurements:

* Primary Endpoint: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. * Secondary Endpoints:

* Evaluation of implant stability at placement. * Assessment of bone density at the time of implant insertion. * Implant osteointegration at 3months after implant placement. * Evaluation of implant survival and success at 3-, 6-and12-months, 3-and 5- years after implant placement. * Rate of all Adverse Device Events (incidence, type, relatedness, severity, seriousness) from the time of grafting procedure up to 5 years after implant placement. * Patient satisfaction 6- and 12-months after implant placement. * Evaluation of the Sulcus index (peri-implant marginal tissue health status) at 6- and 12-months after implant placement.

Вмешательства

• Устройство Tooth extraction and bone graft procedure
  The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery. Tooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with t

Первичные конечные точки

• Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. [Срок оценки: one year]

Вторичные конечные точки (8)

• Assessment of the bone density at implant placement. [Срок оценки: one year]
• Evaluation of the implant primary stability. [Срок оценки: one year]
• Assessment of the implant osteointegration after implant placement [Срок оценки: 15 months]
• Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement [Срок оценки: 5 years]
• Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness [Срок оценки: 5 years]
• Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. [Срок оценки: 2 years]
• Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. [Срок оценки: 2 years]
• Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. [Срок оценки: 2 years]

Критерии участия

Критерии включения

• The subject signed the informed consent form;
• The subject is ≥ 18 and ≤ 80 years old at surgery;
• The subject is in need of a tooth extraction prior to implant placement;
• All four bony walls are preserved after extraction;
• Minimum 8mm height of bone;
• Minimum 7mm thickness of lingual vestibular;
• The subject is willing and able to comply with all investigation related procedures (such as exercising oral hygiene and attending all follow-up visits);
• Full-mouth bleeding score (FMBS) lower than 25%;
• Full-mouth plaque score (FMPI) lower than 25%.

Критерии исключения

• Subject with an acute infection (abscess) at the surgical site;
• Subject with untreated periodontitis or periodontal disease;
• Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy;
• Subject who is pregnant or breastfeeding;
• Subjects is a heavy smoker (>10 cigarettes a day);
• Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation);
• Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia);
• Subject with severe renal dysfunction and severe liver disease;
• Subject with known severe osteoporosis;
• Subject with multiple sclerosis and/or acromegaly;
• Subject follows radiotherapy;
• Subject with psychiatric disorders or under substance abuse (drug or alcohol);
• Subject who participates in other clinical trials interfering with the present protocol;
• Mucosal diseases in the areas to be treated.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Бельгия · 5 центров

• Clinique de la Source DentalMe — Louvain-la-Neuve
• Cabinet Debaty-Techy — Aubel
• Clinique du Faubourg DentalMe — Chaudfontaine
• Centre Hospitalier Université de Liège — Liège
• Centre Oxalys — Namur

Идентификаторы

NCT: NCT06383377 · Pre-market parallel study

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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