Clinical trial NCT06383377: Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Official title: 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.
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Bone Regeneration
Safety Issues
Lead sponsor: Wishbone SA
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
name: Pharmalex
name: Advimago
First posted: 2024-04-25
Enrollment: 96
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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.

Detailed description: In this study, the subjects will be pseudonymized and randomized in a 1:1 ratio between WHA and the selected comparator device Bio-Oss®. The sample size of the study has been computed based on a non-inferiority test between Bio- Oss® and WHA for device performance for the filling of extraction sockets. A total of 96 subjects will be enrolled.

The results will be used to demonstrate the safety, performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017/745.

The endpoints are all accurately based on objective measurements:

* Primary Endpoint: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
* Secondary Endpoints:

  * Evaluation of implant stability at placement.
  * Assessment of bone density at the time of implant insertion.
  * Implant osteointegration at 3months after implant placement.
  * Evaluation of implant survival and success at 3-, 6-and12-months, 3-and 5- years after implant placement.
  * Rate of all Adverse Device Events (incidence, type, relatedness, severity, seriousness) from the time of grafting procedure up to 5 years after implant placement.
  * Patient satisfaction 6- and 12-months after implant placement.
  * Evaluation of the Sulcus index (peri-implant marginal tissue health status) at 6- and 12-months after implant placement.

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.

Primary outcomes:
measure: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
timeFrame: one year
Secondary outcomes:
measure: Assessment of the bone density at implant placement.
timeFrame: one year
measure: Evaluation of the implant primary stability.
timeFrame: one year
measure: Assessment of the implant osteointegration after implant placement
timeFrame: 15 months
measure: 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
timeFrame: 5 years
measure: Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness
timeFrame: 5 years
measure: Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire.
timeFrame: 2 years
measure: Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement.
timeFrame: 2 years
measure: Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement.
timeFrame: 2 years
Other outcomes:
Locations:
city: Louvain-la-Neuve
country: Belgium
facility: Clinique de la Source DentalMe
state: Brabant Wallon
city: Aubel
country: Belgium
facility: Cabinet Debaty-Techy
state: Liège
city: Chaudfontaine
country: Belgium
facility: Clinique du Faubourg DentalMe
state: Liège
city: Liège
country: Belgium
facility: Centre Hospitalier Université de Liège
city: Namur
country: Belgium
facility: Centre Oxalys
Study officials:
affiliation: Clinician
name: Bruno De Carvalho
role: PRINCIPAL_INVESTIGATOR
References: