Actively Recruiting
Prospective Multi-center Randomized Clinical Investigation to Assess Performance and Safety of Wishbone HA as Bone Graft Substitute Compared to Bio-Oss® for Socket Management Before Implant Placement
Led by Wishbone SA · Updated on 2024-05-29
96
Participants Needed
5
Research Sites
260 weeks
Total Duration
On this page
Sponsors
W
Wishbone SA
Lead Sponsor
E
EVAMED
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the use of Wishbone HA (WHA), a bone graft substitute, for filling extraction sockets to support bone preservation before implant placement. This prospective, randomized, single-blinded clinical investigation involves at least five centers and compares WHA to an established product called Bio-Oss®. The study aims to confirm the safety, performance, and benefits of WHA in this bone regeneration context, following regulatory requirements. Participants will have a tooth extracted in a minimally traumatic way, and the socket will be filled with either WHA or Bio-Oss® granules. Follow-up visits will occur at 2 and 6 weeks to monitor healing. Implant placement is planned four months after grafting, with implant loading after a minimum of three months post-placement. Implant survival and success will be assessed up to five years after placement, including long-term follow-up visits. Throughout the study, participants will undergo CBCT imaging to measure bone reconstruction, assessments of implant stability and bone density, and evaluations of implant integration and survival. Patient satisfaction and tissue health around the implant will also be monitored up to a year or more after implant placement. Safety will be tracked by recording any device-related adverse events for up to five years, ensuring comprehensive monitoring during the study period.
CONDITIONS
Brief 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...
- Signed informed consent form
- Age between 18 and 80 years at surgery
- Need for tooth extraction prior to implant placement
- All four bony walls preserved after extraction
- Minimum bone height of 8 mm
- Minimum lingual vestibular thickness of 7 mm
- Willing and able to follow study procedures and attend follow-ups
- Full-mouth bleeding score below 25%
- Full-mouth plaque score below 25%
You will not qualify if you...
- Acute infection (abscess) at the surgical site
- Untreated periodontitis or periodontal disease
- Autoimmune diseases or treatment with antiresorptive drugs or steroids
- Pregnant or breastfeeding
- Heavy smoker (more than 10 cigarettes per day)
- Inability to maintain basic oral hygiene
- Metabolic diseases such as diabetes, hyperparathyroidism, or osteomalacia
- Severe kidney or liver disease
- Known severe osteoporosis
- Multiple sclerosis or acromegaly
- Undergoing radiotherapy
- Psychiatric disorders or substance abuse
- Participation in other interfering clinical trials
- Mucosal diseases in treatment areas
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Procedure day plus 6 weeks post-surgery
Participants undergo tooth extraction and bone graft procedure using either the Wishbone HA or Bio-Oss® device. The extraction socket is prepared and filled, then covered and sutured. Immediate post-operative safety and healing are monitored.
3 visits (surgery day, 2 weeks post-surgery, and 6 weeks post-surgery)
Duration - Approximately 7 months from bone graft procedure to implant loading
Implant placement is performed 4 months after the bone graft procedure, followed by implant loading after a minimum of 3 months post-implant placement and a control visit.
1 visit for implant placement and 1 control visit before implant loading
Duration - Up to 5 years after implant placement
Participants are monitored for implant survival, success, and safety outcomes. Evaluations include implant stability, bone density, osteointegration, peri-implant tissue health, patient satisfaction, and adverse events.
Visits at 3, 6, 12 months, and at 3 and 5 years post-implant placement
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
J
Justine Pirson, R&D Manager
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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