Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: t
View:
• 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%.
Locations
Other Locations
Belgium
Cabinet Debaty-Techy
RECRUITING
Aubel
Clinique du Faubourg DentalMe
RECRUITING
Chaudfontaine
Centre Hospitalier Université de Liège
RECRUITING
Liège
Clinique de la Source DentalMe
RECRUITING
Louvain-la-neuve
Centre Oxalys
RECRUITING
Namur
Contact Information
Primary
Emilie Dory, CEO
emilie.dory@wishbone-biotech.com
+32484706172
Backup
Justine Pirson, R&D Manager
justine.pirson@wishbone-biotech.com
+3249487202
Time Frame
Start Date:2024-04-26
Estimated Completion Date:2030-03-31
Participants
Target number of participants:96
Treatments
Active_comparator: Bio-Oss®
Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.
Experimental: WHA
Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement.