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

Study Overview
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Brief Summary
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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

Official Title
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Prospective, Single Center, Pivotal Investigation to Investigate Efficacy and Safety of WISHBONE HA, Used as Bone Graft Substitute for Different Indications Where Bone Grafting Procedures Are Required Before Implant Placement.

Conditions
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Bone Loss in Jaw

Intervention / Treatment
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* Device: Bone graft substitute


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject signed the informed consent form Subject is ≥18 and ≤ 80 years old. Subject presented in need of: tooth extraction without estimated need of connective tissue grafting OR defect in the upper jaw requiring sinus lift with or without lateral augmentation procedure prior to implant placement 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: Less than 2 mm of remaining keratinized mucosa Severe vertical resorption of the crest (except internal resorptions, i.e. expanded sinuses) Ridge with prior bone augmentation procedure performed (i.e ridge preservation) Any disorders in the planned implant area such as previous tumors, chronic bone disease. Alcohol or drug abuse as noted in subject records or in subject history. Any ongoing application of interfering medication (steroid therapy, bisphosphonate, etc). Reason to believe that the treatment might have a negative effect on the subject's overall situation (psychiatric problems), as noted in subject records or history. Smoking: >10 cigarettes per day

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Bone graft substitute|Evaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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: The implant remains in the jaw The implant is damaged to the extent that it cannot be restored | 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: The implant causes allergic, toxic or gross infectious reactions either locally or systemically. The implant offers anchorage to a functional prosthesis. The implant shows signs of fracture or bending. The implant shows signs of peri-implant radiolucency on an intra-oral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface. The implant shows mobility when individually tested by tapping or rocking with a hand instrument. | 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 = Isolated bleeding spots visible = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding | 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 |