RecruitingNot ApplicableNCT06383377

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

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.

Sponsor

Wishbone SA

Enrollment

96 participants

Start Date

Apr 26, 2024

Study Type

INTERVENTIONAL

Conditions

Safety Issues Bone Regeneration

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria9

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 Criteria14

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.

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Interventions

DEVICETooth 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.