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

NCT ID: NCT06383377

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 96 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-26
• Study Completion Date: 2030-03-31

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.

Conditions

Bone Regeneration; Safety Issues

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Tooth extraction and bone graft procedure

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

Tooth extraction and bone graft procedure

Intervention Type: 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.

Interventions

Tooth extraction and bone graft procedure

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.

Intervention Type: DEVICE

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

EVAMED

OTHER

Sponsor Role: collaborator

Pharmalex

UNKNOWN

Sponsor Role: collaborator

Advimago

UNKNOWN

Sponsor Role: collaborator

Wishbone SA

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bruno De Carvalho

Role: PRINCIPAL_INVESTIGATOR

Clinician

Locations

Clinique de la Source DentalMe

Louvain-la-Neuve, Brabant Wallon, Belgium

Site Status: RECRUITING

Cabinet Debaty-Techy

Aubel, Liège, Belgium

Site Status: RECRUITING

Clinique du Faubourg DentalMe

Chaudfontaine, Liège, Belgium

Site Status: RECRUITING

Centre Hospitalier Université de Liège

Liège, , Belgium

Site Status: RECRUITING

Centre Oxalys

Namur, , Belgium

Site Status: RECRUITING

Countries

Belgium

Central Contacts

Emilie Dory, CEO

Role: CONTACT

emilie.dory@wishbone-biotech.com

+32484706172

Justine Pirson, R&D Manager

Role: CONTACT

justine.pirson@wishbone-biotech.com

+3249487202

Facility Contacts

Sami El Masri

Role: primary

dentiste.elmasri@gmail.com

Bertrand Debaty

Role: primary

bertranddebaty@gmail.com

Souheil Salem

Role: primary

souhsal@yahoo.fr

Bruno De Carvalho

Role: primary

mailto:bruno.decarvalho@chuliege.be

Adrien Bolette

Role: primary

bolette.adrien@gmail.com

Other Identifiers

Pre-market parallel study

Identifier Type: -

Identifier Source: org_study_id