Evaluation of a new bone graft substitute for tooth extraction sites

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.

This study is testing a new bone graft substitute called Wishbone HA to see if it works as well as a standard option for helping people heal after tooth extractions.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 96 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Wishbone SA (Industry-sponsored)
• Locations: 5 sites (Louvain-la-Neuve, Brabant Wallon and 4 other locations)
• Trial ID: NCT06383377 on ClinicalTrials.gov

What this trial studies

This clinical investigation aims to evaluate the performance, safety, and benefits of the Wishbone HA (WHA) as a bone graft substitute in filling extraction sockets to enhance alveolar socket preservation. Conducted across multiple clinical centers, the study will randomly assign participants to receive either WHA or a comparator device, Bio-Oss®, to assess non-inferiority in bone reconstruction. A total of 96 subjects will be enrolled, with endpoints focusing on objective measurements of bone reconstruction, implant stability, and patient satisfaction over a period of up to five years.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 who require tooth extraction and meet specific bone and health criteria.

Not a fit: Patients with acute infections, untreated periodontal disease, or those on certain medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide a safer and more effective option for bone grafting in dental procedures, improving patient outcomes.

How similar studies have performed: Previous studies have shown success with similar bone graft substitutes, indicating potential for this approach.

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.

Where this trial is running

Louvain-la-Neuve, Brabant Wallon and 4 other locations

• Clinique de la Source DentalMe — Louvain-la-Neuve, Brabant Wallon, Belgium (Recruiting)
• Cabinet Debaty-Techy — Aubel, Liège, Belgium (Recruiting)
• Clinique du Faubourg DentalMe — Chaudfontaine, Liège, Belgium (Recruiting)
• Centre Hospitalier Université de Liège — Liège, Belgium (Recruiting)
• Centre Oxalys — Namur, Belgium (Recruiting)

Study contacts

• Principal investigator: Bruno De Carvalho — Clinician
• Study coordinator: Emilie Dory, CEO

Conditions Bone Regeneration; Safety Issues