Bone Loss in Jaw
Conditions
Brief summary
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
Interventions
DEVICEBone 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
Sponsors
Wishbone SA
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* Subject signed the informed consent form * Subject is ≥18 and ≤ 80 years old. * Subject presented in need of: 1. tooth extraction without estimated need of connective tissue grafting OR 2. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Measure of the bone augmentation success | 4 months after procedure | Group 1 - Extraction Socket Management: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Procedure success: ability to successfully perform the implants placement | 4 months after procedure | 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. |
| Site preparation: need for under or over preparation of the osteotomy | 4 months after procedure | 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). |
| Assessment of the bone quality and bone quantity | 4 months after procedure | Group 1 - Extraction Socket Management: Bone quality and bone quantity will be assessed following Lekholm and Zarb classification. |
| Implant survival | 1 year after after definitive prosthesis delivery | 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 |
| Implant success | 1 year after after definitive prosthesis delivery | Implant Success will be defined in accordance with the criteria proposed by van Steenberghe. Answering yes or no to the following statements: 1. The implant causes allergic, toxic or gross infectious reactions either locally or systemically. 2. The implant offers anchorage to a functional prosthesis. 3. The implant shows signs of fracture or bending. 4. The implant shows signs of peri-implant radiolucency on an intra-oral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface. 5. The implant shows mobility when individually tested by tapping or rocking with a hand instrument. |
| Safety endpoint: Collection of all device related adverse events | 4 months after procedure | 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 |
| Plaque index evaluation | 1 year after definitive prosthesis delivery | 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 |
| Bleeding index evaluation | 1 year after definitive prosthesis delivery | 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. = Isolated bleeding spots visible 2. = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding |
| Keratinized mucosa evaluation | 1 year after definitive prosthesis delivery | 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 |
| Patient Oral health profile evaluation | 1 year follow-up visit | 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 |
| Papilla index evaluation | 1 year after definitive prosthesis delivery | 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 |
Countries
Belgium
Outcome results
None listed