NCT06383377 Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
| NCT ID | NCT06383377 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Wishbone SA |
| Condition | Bone Regeneration |
| Study Type | INTERVENTIONAL |
| Enrollment | 96 participants |
| Start Date | 2024-04-26 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 96 participants in total. It began in 2024-04-26 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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
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.
Contact & Investigator
Bruno De Carvalho
PRINCIPAL INVESTIGATOR
Clinician
Frequently Asked Questions
Who can join the NCT06383377 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 80 Years, studying Bone Regeneration. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06383377 currently recruiting?
Yes, NCT06383377 is actively recruiting participants. Contact the research team at emilie.dory@wishbone-biotech.com for enrollment information.
Where is the NCT06383377 trial being conducted?
This trial is being conducted at Louvain-la-Neuve, Belgium, Aubel, Belgium, Chaudfontaine, Belgium, Liège, Belgium and 1 additional location.
Who is sponsoring the NCT06383377 clinical trial?
NCT06383377 is sponsored by Wishbone SA. The principal investigator is Bruno De Carvalho at Clinician. The trial plans to enroll 96 participants.