Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWishbone SA
About this trial
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.
Eligibility criteria
Qualifiers
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;
Disqualifiers
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;
Trial design
Treatments tested in this trial
- Tooth extraction and bone graft procedure
Treatment groups
96 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov