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Evaluation of efficacy and safety of Wishbone HA as bone graft substitute, a pre-market clinical investigation.
Group1: Extraction Socket management Group 2: Sinus lift
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Bone graft substitute | Device | Evaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement |
| Measure | Description | Time Frame |
|---|---|---|
| Measure of the bone augmentation success | Group 1 - Extraction Socket Management: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT | 4 months after procedure |
| Measure of the bone augmentation success | Group 2 - Sinus lift: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT | 6 months after procedure |
| Measure | Description | Time Frame |
|---|---|---|
| Safety endpoint: Collection of all device related adverse events | Group 1 - Extraction Socket Management: Collection of all device related adverse events reported by the investigator and by the patient from the time of procedure up to the time of implant insertion: Abnormal tissue reaction of the surrounding area, Not expected complications, Loss of material, Additional signs of Inflammation, Wound dehiscence, Membrane exposure, Persistent feeling of discomfort at the gingival incision |
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Inclusion Criteria:
Subject signed the informed consent form
Subject is ≥18 and ≤ 80 years old.
Subject presented in need of:
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%
The subject displays no clinical contraindications for a 2-stage surgical procedure
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Liège | Recruiting | Liège | 4000 | Belgium |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Jul 14, 2025 | |
| Reset | Jul 31, 2025 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 14, 2025 | Jul 31, 2025 |
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| 4 months after procedure |
| Safety endpoint: Collection of all device related adverse events | Group 2 - Sinus lift: Collection of all device related adverse events reported by the investigator and by the patient from the time of procedure up to the time of implant insertion: Abnormal tissue reaction of the surrounding area, Not expected complications, Loss of material, Additional signs of Inflammation, Wound dehiscence, Membrane exposure, Persistent feeling of discomfort at the gingival incision | 6 months after procedure |
| Procedure success: ability to successfully perform the implants placement | Group 1 - Extraction Socket Management: The procedure is a success if the bone is sufficient for implant placement and implant can be placed successfully with sufficient good primary stability (>10Ncm) measured using a torque wrench. | 4 months after procedure |
| Procedure success: ability to successfully perform the implants placement | Group 2 - Sinus lift: The procedure is a success if the bone is sufficient for implant placement and implant can be placed successfully with sufficient good primary stability (>10Ncm) measured using a torque wrench. | 6 months after procedure |
| Site preparation: need for under or over preparation of the osteotomy | Group 1 - Extraction Socket Management: If the second CBCT shows favourable results, implant placement will be performed. Depending on the clinician's choice, a CAD-CAM surgical guide could be prepared to facilitate proper positioning of the implant(s). Access to the bone crest will be made with an as minimally-invasive surgical approach as possible, depending on the surgeon's choice. The drilling procedure will be performed according to the manufacturer's instructions for the placement the implant(s); during this drilling procedure, the clinician will determine if the bone quality is sufficient for placing the implant(s). | 4 months after procedure |
| Site preparation: need for under or over preparation of the osteotomy | Group 2 - Sinus lift: If the second CBCT shows favourable results, implant placement will be performed. Depending on the clinician's choice, a CAD-CAM surgical guide could be prepared to facilitate proper positioning of the implant(s). Access to the bone crest will be made with an as minimally-invasive surgical approach as possible, depending on the surgeon's choice. The drilling procedure will be performed according to the manufacturer's instructions for the placement the implant(s); during this drilling procedure, the clinician will determine if the bone quality is sufficient for placing the implant(s). | 6 months after procedure |
| Assessment of the bone quality and bone quantity | Group 1 - Extraction Socket Management: Bone quality and bone quantity will be assessed following Lekholm and Zarb classification. | 4 months after procedure |
| Assessment of the bone quality and bone quantity | Group 2 - Sinus lift: Bone quality and bone quantity will be assessed following Lekholm and Zarb classification. | 6 months after procedure |
| Implant survival | Implant survival will be assessed by answering if:
| 1 year after after definitive prosthesis delivery |
| Implant success | Implant Success will be defined in accordance with the criteria proposed by van Steenberghe. Answering yes or no to the following statements:
| 1 year after after definitive prosthesis delivery |
| Papilla index evaluation | The soft tissue contour adjacent to the implant is assessed from definitive prosthetic placement to the 1-year follow up visit using the papilla index according to Jemt 1997 | 1 year after definitive prosthesis delivery |
| Plaque index evaluation | The plaque accumulation is assessed using the modified Plaque Index (mPlI) according to Mombelli et.al: 0 = No detectible plaque 1 = Plaque only recognized by running a probe across the marginal surface of the implant 2 = Plaque can be seen by the naked eye 3 = Abundance of soft matter | 1 year after definitive prosthesis delivery |
| Bleeding index evaluation | The bleeding tendency is assessed by a modified Sulcus Bleeding Index (mBI) according to Mombelli et. al: 0 = No bleeding when a periodontal probe is passed along the gingival margin adjacent to the implant
| 1 year after definitive prosthesis delivery |
| Keratinized mucosa evaluation | Classification will be performed as: 0 = No keratinized mucosa around the implant. 1= Keratinized mucosa Measurement in mm of the keratinized mucosa in the apico-coronal direction using a periodontal probe | 1 year after definitive prosthesis delivery |
| Patient Oral health profile evaluation | The quality of life will be assessed at all visits by a questionnaire which is going to be completed be the subject. The shortened version from Brennan et al., OHIP-14 has been adopted for use in this investigation | 1 year follow-up visit |