Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
- Conditions
- Safety IssuesBone Regeneration
- Registration Number
- NCT06383377
- Lead Sponsor
- Wishbone SA
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 96
- 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%.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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.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 boneEvaluation 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 satisfiedImplant 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 implantCollection 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 materialEvaluation 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.
Trial Locations
- Locations (5)
Clinique de la Source DentalMe
🇧🇪Louvain-la-Neuve, Brabant Wallon, Belgium
Cabinet Debaty-Techy
🇧🇪Aubel, Liège, Belgium
Clinique du Faubourg DentalMe
🇧🇪Chaudfontaine, Liège, Belgium
Centre Hospitalier Université de Liège
🇧🇪Liège, Belgium
Centre Oxalys
🇧🇪Namur, Belgium
Clinique de la Source DentalMe🇧🇪Louvain-la-Neuve, Brabant Wallon, BelgiumSami El MasriContactdentiste.elmasri@gmail.comLaurane PansaersSub Investigator