Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Recruiting now · Not applicable
Conditions studied: Bone Regeneration, Safety Issues
In brief
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.
Key facts
- Study ID
- NCT06383377
- Run by
- Wishbone SA
- People needed
- 96
- Starts
- 2024-04-26
- Expected to finish
- 2030-03-31
- Last updated by the study team
- 2024-05-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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%.
You may not qualify if…
- 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.
Where it is running
- Clinique de la Source DentalMe — Louvain-la-Neuve, Brabant Wallon, Belgium (enrolling)
- Cabinet Debaty-Techy — Aubel, Liège, Belgium (enrolling)
- Clinique du Faubourg DentalMe — Chaudfontaine, Liège, Belgium (enrolling)
- Centre Hospitalier Université de Liège — Liège, Belgium (enrolling)
- Centre Oxalys — Namur, Belgium (enrolling)
Full record on ClinicalTrials.gov
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