Actively Recruiting
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Led by Wishbone SA · Updated on 2024-05-29
96
Participants Needed
5
Research Sites
309 weeks
Total Duration
On this page
Sponsors
W
Wishbone SA
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- The subject signed the informed consent form
- The subject is 63; 18 and 64; 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
Clinique de la Source DentalMe
Louvain-la-Neuve, Brabant Wallon, Belgium, 1348
Actively Recruiting
2
Cabinet Debaty-Techy
Aubel, Liège, Belgium, 4880
Actively Recruiting
3
Clinique du Faubourg DentalMe
Chaudfontaine, Liège, Belgium, 4053
Actively Recruiting
4
Centre Hospitalier Université de Liège
Liège, Belgium, 4000
Actively Recruiting
5
Centre Oxalys
Namur, Belgium, 5020
Actively Recruiting
Research Team
E
Emilie Dory, CEO
CONTACT
J
Justine Pirson, R&D Manager
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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