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

NARecruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

April 26, 2024

Primary Completion Date

March 31, 2025

Study Completion Date

March 31, 2030

Conditions
Bone RegenerationSafety Issues
Interventions
DEVICE

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."

Trial Locations (5)

1348

RECRUITING

Clinique de la Source DentalMe, Louvain-la-Neuve

4000

RECRUITING

Centre Hospitalier Université de Liège, Liège

4053

RECRUITING

Clinique du Faubourg DentalMe, Chaudfontaine

4880

RECRUITING

Cabinet Debaty-Techy, Aubel

5020

RECRUITING

Centre Oxalys, Namur

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

EVAMED

OTHER

collaborator

Pharmalex

UNKNOWN

collaborator

Advimago

UNKNOWN

lead

Wishbone SA

INDUSTRY