Bone Regeneration, Safety Issues
Conditions
Brief summary
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.
Detailed description
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: * Evaluation of implant stability at placement. * Assessment of bone density at the time of implant insertion. * Implant osteointegration at 3months after implant placement. * Evaluation of implant survival and success at 3-, 6-and12-months, 3-and 5- years after implant placement. * Rate of all Adverse Device Events (incidence, type, relatedness, severity, seriousness) from the time of grafting procedure up to 5 years after implant placement. * Patient satisfaction 6- and 12-months after implant placement. * Evaluation of the Sulcus index (peri-implant marginal tissue health status) at 6- and 12-months after implant placement.
Interventions
DEVICETooth extraction and bone graft procedure
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.
Sponsors
EVAMED
Pharmalex
Advimago
Wishbone SA
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion criteria
* The subject signed the informed consent form; * The subject is ≥ 18 and ≤ 80 years old at surgery; * The subject is in need of a tooth extraction prior to implant placement; * All four bony walls are preserved after extraction; * Minimum 8mm height of bone; * Minimum 7mm thickness of lingual vestibular; * 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%.
Exclusion criteria
* Subject with an acute infection (abscess) at the surgical site; * Subject with untreated periodontitis or periodontal disease; * Subject with autoimmune diseases or subjects that had received or were currently receiving treatment with antiresorptive drugs (e.g., bisphosphonates), or steroid therapy; * Subject who is pregnant or breastfeeding; * Subjects is a heavy smoker (\>10 cigarettes a day); * Subject with an inability to conduct basic oral hygiene (poor oral hygiene and motivation); * Subject with metabolic diseases (diabetes, hyperparathyroidism, osteomalacia); * Subject with severe renal dysfunction and severe liver disease; * Subject with known severe osteoporosis; * Subject with multiple sclerosis and/or acromegaly; * Subject follows radiotherapy; * Subject with psychiatric disorders or under substance abuse (drug or alcohol); * Subject who participates in other clinical trials interfering with the present protocol; * Mucosal diseases in the areas to be treated.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. | one year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Evaluation of the implant primary stability. | one year | Implants primary stability determined by using the torque wrench at implant placement. |
| Assessment of the implant osteointegration after implant placement | 15 months | Taping of the implant and a rotation test will be performed. A torque wrench will be used at 10Ncm for the rotation test. |
| 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 | 5 years | At 3-, 6- and 12-months and 3- and 5-years after implant placement, 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. The success of the implant will be assessed with the criteria from Buser et al.: * Absence of persistent subjective complaints such as pain, foreign body sensation and/or dysesthesia * Absence of a peri-implant infection with suppuration * Absence of mobility * Absence of a continuous radiolucency around the implant |
| Assessment of the bone density at implant placement. | one year | 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: 1. = soft bone 2. = medium bone 3. = hard bone |
| Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire. | 2 years | The questionnaire will focus on the following questions: * How satisfied are you with the length of procedures and how they affected your daily functioning? * How satisfied are you with the function and aesthetics of the final restoration? * How satisfied are you with the pain associated with the treatment? The scale for each of these questions will be as follows: 0= Not satisfied 1. Fairly satisfied 2. Satisfied 3. Extremely satisfied |
| Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement. | 2 years | 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; 1. Isolated bleeding spots visible; 2. Blood forms on a confluent red line on the margin; 3. Heavy or profuse bleeding. |
| Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement. | 2 years | 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. |
| Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness | 5 years | 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: * Pain * Flap sloughing * Infection * Inflammation at the surgical site * Swelling at the surgical site * Bleeding * Bone loss * Loss of graft material |
Countries
Belgium
Contacts
Primary ContactEmilie Dory, CEO
Backup ContactJustine Pirson, R&D Manager
Outcome results
None listed