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| Name | Class |
|---|---|
| EVAMED | OTHER |
| Pharmalex | UNKNOWN |
| Advimago | UNKNOWN |
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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.
In this study, the subjects will be pseudonymized and randomized in a 1:1 ratio between WHA and the selected comparator device Bio-Oss®. The sample size of the study has been computed based on a non-inferiority test between Bio- Oss® and WHA for device performance for the filling of extraction sockets. A total of 96 subjects will be enrolled.
The results will be used to demonstrate the safety, performance and benefit of the product WHA in the socket indication in compliance with the MDR 2017/745.
The endpoints are all accurately based on objective measurements:
Primary Endpoint: Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
Secondary Endpoints:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Bio-Oss® | Active Comparator | Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. |
|
| WHA | Experimental | Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tooth extraction and bone graft procedure | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| one year |
| Evaluation of the implant primary stability. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emilie Dory, CEO | Contact | +32484706172 | emilie.dory@wishbone-biotech.com | |
| Justine Pirson, R&D Manager | Contact | +3249487202 | justine.pirson@wishbone-biotech.com |
| Name | Affiliation | Role |
|---|---|---|
| Bruno De Carvalho | Clinician | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinique de la Source DentalMe | Recruiting | Louvain-la-Neuve | Brabant Wallon | 1348 | Belgium |
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The parallel group will be treated with the product Bio-Oss® in a 1:1 randomization. Bio- Oss® is a natural bone mineral of bovine origin. Bio-Oss® is available as granules of spongious bone. Sterilization of Bio-Oss® is carried out by irradiation. Bio-Oss® has a macro- and microporous structure similar to human spongious bone. Bio-Oss® supports the in-growth of new bone at the implantation site by serving as a stable scaffold for osteoblasts; over time it is subject to the physiological remodeling process. Bio-Oss® is slowly resorbable, depending on the physiological environment of the individual patient, or integrated into the host bone. The highly purified osteoconductive mineral structure is produced from natural bone in a multistage purification process, adhering to the strictest safety regulations.
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Patients will not be informed of their randomization assignment until the 1 year post implant placement follow-up visit. At this timepoint, the primary endpoint will have been achieved (at the implant placement visit) as well as the majority of the secondary endpoints. After the bone grafting surgery, all patients will receive an identic implant cart that does not break the blinding of the study. 1 year after implant placement, the patients will receive their definitive implant cart.
|
Implants primary stability determined by using the torque wrench at implant placement. |
| one year |
| 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 |
| 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 success of the implant will be assessed with the criteria from Buser et al.:
| 5 years |
| 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:
| 5 years |
| Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. | The questionnaire will focus on the following questions:
The scale for each of these questions will be as follows: 0= Not satisfied
| 2 years |
| 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;
| 2 years |
| 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 |
| Cabinet Debaty-Techy | Recruiting | Aubel | Liège | 4880 | Belgium |
|
| Clinique du Faubourg DentalMe | Recruiting | Chaudfontaine | Liège | 4053 | Belgium |
|
| Centre Hospitalier Université de Liège | Recruiting | Liège | 4000 | Belgium |
|
| Centre Oxalys | Recruiting | Namur | 5020 | Belgium |
|
| ID | Term |
|---|---|
| D014081 | Tooth Extraction |
| D016025 | Bone Transplantation |
| ID | Term |
|---|---|
| D019647 | Oral Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D003813 | Dentistry |
| D016378 | Tissue Transplantation |
| D064987 | Cell- and Tissue-Based Therapy |
| D001691 | Biological Therapy |
| D013812 | Therapeutics |
| D019637 | Orthopedic Procedures |
| D014180 | Transplantation |
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