Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorWishbone SA
About this trial
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 criteria
This trial accepts healthy volunteersQualifiers
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;
Disqualifiers
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;
Trial design
Design model
Parallel
Treatments tested in this trial
Tooth extraction and bone graft procedure
DeviceThe 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.
Treatment groups
96 Participants
are divided into 2 treatment groupsGroup A: Bio-Oss®Active comparator 1 intervention
Group B: WHAExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
Bone thickness will be measured using CBCT scan 4 months after the bone augmentation procedure and just before implant insertion. The most apical point from the extraction socket defined at baseline will be set as a reference. The vertical reference line will be drawn in the center of the extraction socket crossing the apical reference point. The horizontal reference line is drawn perpendicular to the vertical line crossing the apical reference point. Based on these marks, 3 measurements will be done at 1, 3 and 5 mm from the top of the crest.
Time frame
one yearSecondary outcomes
1
Assessment of the bone density at implant placement.
Assessment of the bone density on the first and second half of the defect at implant placement using a Likert scale at implant placement. Likert scale: 1. = soft bone 2. = medium bone 3. = hard bone
Time frame
one year2
Evaluation of the implant primary stability.
Implants primary stability determined by using the torque wrench at implant placement.
Time frame
one year3
Assessment of the implant osteointegration after implant placement
Taping of the implant and a rotation test will be performed. A torque wrench will be used at 10Ncm for the rotation test.
Time frame
15 months4
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
At 3-, 6- and 12-months and 3- and 5-years after implant placement, implant survival will be assessed by answering if: 1. The implant remains in the jaw. 2. The implant is damaged to the extent that it cannot be restored. The success of the implant will be assessed with the criteria from Buser et al.: * Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia * Absence of a peri-implant infection with suppuration * Absence of mobility * Absence of a continuous radiolucency around the implant
Time frame
5 yearsSponsors and contacts
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Source ClinicalTrials.gov