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

RecruitingNAAges 18 Years - 80 YearsAllWishbone SA
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: * 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%. Exclusion Criteria: * 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.
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What it tests

  • Tooth extraction and bone graft procedure
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Where

5 sites
Clinique de la Source DentalMe
Louvain-la-Neuve, Belgium
Cabinet Debaty-Techy
Aubel, Belgium
Clinique du Faubourg DentalMe
Chaudfontaine, Belgium
Centre Hospitalier Université de Liège
Liège, Belgium
Centre Oxalys
Namur, Belgium
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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