Bone RegenerationNCT06383377
Evaluation of Performance, Safety and Benefit of the Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
A study testing Tooth extraction and bone graft procedure in people with Bone Regeneration and Safety Issues, run by Wishbone SA at 5 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Regeneration, Safety Issues
- What is being tested?
- Tooth extraction and bone graft procedure
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- 5 sitesBelgium
- Study dates
- 26 Apr 2024to 31 Mar 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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;
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- 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%.
Who cannot join
- 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);
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- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
Belgium5 sites, 5 recruiting
- Recruiting
Cabinet Debaty-Techy
Aubel, Liège, 4880
Bertrand Debaty, bertranddebaty@gmail.com
- Recruiting
Clinique du Faubourg DentalMe
Chaudfontaine, Liège, 4053
Souheil Salem, souhsal@yahoo.fr
- Recruiting
Centre Hospitalier Université de Liège
Liège, 4000
Bruno De Carvalho, mailto:bruno.decarvalho@chuliege.be
Lemmy Liegeois
- Recruiting
Clinique de la Source DentalMe
Louvain-la-Neuve, Brabant Wallon, 1348
Sami El Masri, dentiste.elmasri@gmail.com
Laurane Pansaers
- Recruiting
Centre Oxalys
Namur, 5020
Adrien Bolette, bolette.adrien@gmail.com
About this study
Official title: Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.
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.
Read the 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.
- Conditions
- Bone Regeneration, Safety Issues
- Being tested
- Tooth extraction and bone graft procedure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tooth extraction and bone graft procedureDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Bio-Oss® | Active comparator | Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. Receives: Device: Tooth extraction and bone graft procedure |
| WHA | Experimental | Tooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. Receives: Device: Tooth extraction and bone graft procedure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
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.
Measured: one year
Secondary outcomes (8)
Assessment of the bone density at implant placement.
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:
- = soft bone
- = medium bone
- = hard bone
Measured: one year
Evaluation of the implant primary stability.
Implants primary stability determined by using the torque wrench at implant placement.
Measured: one year
Assessment of the implant osteointegration after implant placement
Taping of the implant and a rotation test will be performed. A torque wrench will be used at 10Ncm for the rotation test.
Measured: 15 months
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
At 3-, 6- and 12-months and 3- and 5-years after implant placement, 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.
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
Measured: 5 years
Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness
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
Measured: 5 years
Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire.
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
- Fairly satisfied
- Satisfied
- Extremely satisfied
Measured: 2 years
Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement.
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;
- Isolated bleeding spots visible;
- Blood forms on a confluent red line on the margin;
- Heavy or profuse bleeding.
Measured: 2 years
Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement.
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start26 Apr 2024
- Primary completion31 Mar 2025 (estimated)
- Study completion31 Mar 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 96 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wishbone SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED, Pharmalex, Advimago
- Responsible party
- Sponsor
- Investigators
- Bruno De Carvalho, Principal investigator, Clinician
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06383377
- Sponsor's protocol ID
- Pre-market parallel study
- Status last verified
- May 2024
- First submitted
- 10 Apr 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Multi-center, Randomized, Single Blinded and Parallel Controlled Clinical Investigation to Assess the Performance, Safety and Benefit of the Wishbone HA Medical Device, a Deproteinized Bovine Bone Material, as a Bone Graft Substitute in the Socket Management Indication Requiring Bone Grafting Procedure Before Implant Placement.
- ClinicalTrials.gov ID
- NCT06383377
- Acronym / sponsor ID
- Pre-market parallel study
- Conditions
- Bone Regeneration, Safety Issues
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 96 participants (estimated)
- Lead sponsor
- Wishbone SAIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED, Pharmalex, Advimago
- Study start
- 26 Apr 2024 (actual)
- Primary completion
- 31 Mar 2025 (estimated)
- Study completion
- 31 Mar 2030 (estimated)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Bio-Oss® | Active comparator | Device: Tooth extraction and bone graft procedureTooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the comparator (Bio-Oss® Geistlich, granules 0.25 - 1mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. |
| WHA | Experimental | Device: Tooth extraction and bone graft procedureTooth scheduled for extraction will be removed in the least traumatic way. The socket will be filled with the investigational device (WHA, granules 0.25- 1.0mm). Two follow up visits to monitor the healing process will take place at 2 and 6 weeks after surgery. Implant placement will be performed 4 months after the regenerative procedure. Implant loading will be allowed after having waited a minimum of 3 months after the implant placement and after a control visit. The implant survival and success will be assessed at 3, 6 and 12 months after implant placement. A long-term follow-up will evaluate the implant survival and success at 3 and 5 years post implant placement. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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;
Key exclusion criteria (14 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Tooth extraction and bone graft procedureThe 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. | Device | Bio-Oss®, WHA |
Primary outcome
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure.
Time frame: 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.
8 secondary outcomes
Assessment of the bone density at implant placement.
Time frame: one year
Evaluation of the implant primary stability.
Time frame: one year
Assessment of the implant osteointegration after implant placement
Time frame: 15 months
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
Time frame: 5 years
Collection of all adverse events (AEs) related to the device and/or procedure, and assessment of incidence, type, severity, seriousness
Time frame: 5 years
Evaluation of patient satisfaction at 6- and 12-months after implant placement using questionnaire.
Time frame: 2 years
Evaluation of the peri-implant marginal tissue health status at 6 and 12 months after implant placement.
Time frame: 2 years
Evaluation of the evolution of the interproximal bone level 3- and 12-months after implant placement.
Time frame: 2 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Bruno De Carvalho principal investigator
Clinician
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tooth extraction and bone graft procedure in people with Bone Regeneration and Safety Issues, run by Wishbone SA at 5 sites in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emilie Dory, CEO (+32484706172, emilie.dory@wishbone-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone reconstruction as measured by CBCT (in mm) after bone grafting procedure. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.