Evaluation of a new bone graft substitute for tooth extraction sites

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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
• Email: emilie.dory@wishbone-biotech.com
• Phone: +32484706172

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.