Safety Issues Clinical Trial
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.
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.
Status | Recruiting |
Enrollment | 96 |
Est. completion date | March 31, 2030 |
Est. primary completion date | March 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 80 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
Belgium | Cabinet Debaty-Techy | Aubel | Liège |
Belgium | Clinique du Faubourg DentalMe | Chaudfontaine | Liège |
Belgium | Centre Hospitalier Université de Liège | Liège | |
Belgium | Clinique de la Source DentalMe | Louvain-la-Neuve | Brabant Wallon |
Belgium | Centre Oxalys | Namur |
Lead Sponsor | Collaborator |
---|---|
Wishbone SA | Advimago, EVAMED, Pharmalex |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | one year | |
Secondary | 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: = soft bone = medium bone = hard bone |
one year | |
Secondary | Evaluation of the implant primary stability. | Implants primary stability determined by using the torque wrench at implant placement. | one year | |
Secondary | 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. | 15 months | |
Secondary | 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:
The implant remains in the jaw. 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 |
5 years | |
Secondary | Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness | At a minimum prior and after implantation, and at each follow-up thereafter, the following treatment-emergent local AEs, namely any local AE for which the start date is on or after the date that the intervention began, will be assessed for severity, seriousness, and relatedness to the device and/or procedure and recorded in the eCRF using standard medical terminology:
Pain Flap sloughing Infection Inflammation at the surgical site Swelling at the surgical site Bleeding Bone loss Loss of graft material |
5 years | |
Secondary | Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. | The questionnaire will focus on the following questions:
How satisfied are you with the length of procedures and how they affected your daily functioning? How satisfied are you with the function and aesthetics of the final restoration? How satisfied are you with the pain associated with the treatment? The scale for each of these questions will be as follows: 0= Not satisfied Fairly satisfied Satisfied Extremely satisfied |
2 years | |
Secondary | Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. | Assessment of the peri-implant marginal tissue health status using Sulcus Bleeding Index (mBI)
0= No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant; Isolated bleeding spots visible; Blood forms on a confluent red line on the margin; Heavy or profuse bleeding. |
2 years | |
Secondary | Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. | The bone to implant neck distance will be evaluated at the mesial and distal aspect from the implant at 3- and 12-months post implant placement. | 2 years |
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