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RECRUITING
NCT06383377
NA

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

Sponsor: Wishbone SA

View on ClinicalTrials.gov

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.

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.

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

96

Start Date

2024-04-26

Completion Date

2030-03-31

Last Updated

2024-05-29

Healthy Volunteers

Yes

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.

Locations (5)

Clinique de la Source DentalMe

Louvain-la-Neuve, Brabant Wallon, Belgium

Cabinet Debaty-Techy

Aubel, Liège, Belgium

Clinique du Faubourg DentalMe

Chaudfontaine, Liège, Belgium

Centre Hospitalier Université de Liège

Liège, Belgium

Centre Oxalys

Namur, Belgium