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

Wishbone SA47 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Bone Loss in Jaw

Interventions

Bone graft substituteDEVICE

Evaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (1)

CHU de Liège

Liège, Belgium

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: 6 months after procedure

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Data from ClinicalTrials.gov

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Time frame: 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.

Time frame: 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).

Time frame: 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).

Time frame: 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.

Time frame: 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.

Time frame: 6 months after procedure

Implant survival

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

Time frame: 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. 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.

Time frame: 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

Time frame: 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

Time frame: 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. = Isolated bleeding spots visible 2. = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding

Time frame: 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

Time frame: 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

Time frame: 1 year follow-up visit