Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation

NCT06383377 | Recruiting

• 1 other identifier: Pre-market parallel study
• Study Type: interventional
• Target: 96
• Locations: 1 country
• Sites: 5

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.

Conditions

Bone Regeneration; Safety Issues

Outcome Measures

Primary Outcomes (1)

• Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.

  Bone thickness will be measured using CBCT scan 4 months after the bone augmentation procedure and just before implant insertion. The most apical point from the extraction socket defined at baseline will be set as a reference. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. The horizontal reference line is drawn perpendicular to the vertical line crossing the apical reference point. Based on these marks, 3 measurements will be done at 1, 3 and 5 mm from the top of the crest.

  one year

Secondary Outcomes (8)

• Assessment of the bone density at implant placement.

  one year

• Evaluation of the implant primary stability.

  one year

• Assessment of the implant osteointegration after implant placement

  15 months

• Implant survival rate and success evaluated at 3-, 6- and 12-months and 3- and 5- To evaluate implant survival and success 3-, 6- and 12- months and 3- and 5-years after implant placement

  5 years

• Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness

  5 years

Study Arms (2)

Bio-Oss®

ACTIVE COMPARATOR

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.

Device: Tooth extraction and bone graft procedure

WHA

EXPERIMENTAL

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.

Device: Tooth extraction and bone graft procedure

Interventions

Tooth extraction and bone graft procedure DEVICE

The subject will receive a flash dose of 2 gr of amoxicillin or 600 mg of Clindamycin 1 hour before the surgery. Tooth will be extracted using gentle techniques to guarantee an atraumatic extraction. If the socket presents insufficient bleeding, the clinician must use an appropriate procedure to induce bleeding. The extraction site must be carefully cleaned. Extraction socket will then be filled with WHA or Bio-Oss previously hydrated with saline solution (0.9%). Extraction socket packed with the graft will be covered with a collagen sponge (Geistlich Mucograft® Seal) and sutured (cross suture, Vicryl rapide 4.0). If required, a limited connective tissue graft can be placed in the vestibular region. A CBCT scan will be performed after the bone graft procedure, i.e., after the extraction socket and the biomaterial placement, to measure the initial bone width. The safety of the investigational device will be evaluated.

Bio-Oss®; WHA

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wishbone SA: lead
• EVAMED: collaborator
• Pharmalex: collaborator
• Advimago: collaborator

Study Sites (5)

Clinique de la Source DentalMe

Louvain-la-Neuve, Brabant Wallon, 1348, Belgium

RECRUITING

Cabinet Debaty-Techy

Aubel, Liège, 4880, Belgium

RECRUITING

Clinique du Faubourg DentalMe

Chaudfontaine, Liège, 4053, Belgium

RECRUITING

Centre Hospitalier Université de Liège

Liège, 4000, Belgium

RECRUITING

Centre Oxalys

Namur, 5020, Belgium

RECRUITING

MeSH Terms

Interventions

Tooth Extraction; Bone Transplantation

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry; Tissue Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Orthopedic Procedures; Transplantation

Study Officials

• Bruno De Carvalho

  Clinician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilie Dory, CEO

CONTACT

+32484706172; emilie.dory@wishbone-biotech.com

Justine Pirson, R&D Manager

CONTACT

+3249487202; justine.pirson@wishbone-biotech.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations.

Study Record Dates

• First Submitted: April 10, 2024
• First Posted: April 25, 2024
• Study Start: April 26, 2024
• Primary Completion: March 31, 2025
• Study Completion (Estimated): March 31, 2030
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

BE (5)