Bone Loss in JawNCT04054219
Evaluation of Efficacy and Safety of Wishbone HA as Bone Graft Substitute, a Pre-market Clinical Investigation
A study testing Bone graft substitute in people with Bone Loss in Jaw, run by Wishbone SA at 1 site in Belgium.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Bone Loss in Jaw
- What is being tested?
- Bone graft substitute
- Type of treatment
- Medical device
- How many people
- 47 participants
- Where
- 1 siteBelgium
- Study dates
- 8 Jul 2019to 31 May 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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
- Subject signed the informed consent form
- Subject is ≥18 and ≤ 80 years old.
- Subject presented in need of:
- tooth extraction without estimated need of connective tissue grafting OR
- 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).
Show all 9Show fewer
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
CHU de Liège
Liège, 4000
France Lambert, 003243667654, France.Lambert@chuliege.be
About this study
Official title: Prospective, Single Center, Pivotal Investigation to Investigate Efficacy and Safety of WISHBONE HA, Used as Bone Graft Substitute for Different Indications Where Bone Grafting Procedures Are Required Before Implant Placement.
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
- Conditions
- Bone Loss in Jaw
- Being tested
- Bone graft substitute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 6 months after procedure
Secondary outcomes (15)
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
Measured: 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
Measured: 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.
Measured: 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.
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: 6 months after procedure
Implant survival
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
Measured: 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:
- The implant causes allergic, toxic or gross infectious reactions either locally or systemically.
- The implant offers anchorage to a functional prosthesis.
- The implant shows signs of fracture or bending.
- The implant shows signs of peri-implant radiolucency on an intra-oral radiograph using a paralleling technique strictly perpendicular to the implant-bone interface.
- The implant shows mobility when individually tested by tapping or rocking with a hand instrument.
Measured: 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
Measured: 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
Measured: 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
- = Isolated bleeding spots visible
- = Blood forms a confluent red line on the margin 3 = Heavy or profuse bleeding
Measured: 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
Measured: 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
Measured: 1 year follow-up visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2019
- Study start8 Jul 2019
- Primary completion28 Feb 2020 (estimated)
- Study completion31 May 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bone Loss in JawStudies 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wishbone SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04054219
- Sponsor's protocol ID
- 20181207_WHA_CIP
- Status last verified
- Aug 2019
- First submitted
- 7 Aug 2019
- Last updated
- 21 Aug 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single Center, Pivotal Investigation to Investigate Efficacy and Safety of WISHBONE HA, Used as Bone Graft Substitute for Different Indications Where Bone Grafting Procedures Are Required Before Implant Placement.
- ClinicalTrials.gov ID
- NCT04054219
- Acronym / sponsor ID
- 20181207_WHA_CIP
- Conditions
- Bone Loss in Jaw
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Wishbone SAIndustry (pharma, biotech, devices)
- Study start
- 8 Jul 2019 (actual)
- Primary completion
- 28 Feb 2020 (estimated)
- Study completion
- 31 May 2021 (estimated)
- First posted
- 13 Aug 2019 (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.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Subject signed the informed consent form
- Subject is ≥18 and ≤ 80 years old.
- Subject presented in need of:
- 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%
Key exclusion criteria (8 listed)
- 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.
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 |
|---|---|---|
| Bone graft substituteEvaluation of a device made of deproteinized bovine bone material as bone graft substitute in different indications requiring bone grafting procedures before implant placement | Device | – |
Primary outcome
Measure of the bone augmentation success
Time frame: 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
Measure of the bone augmentation success
Time frame: 6 months after procedure
Group 2 - Sinus lift: Efficacy endpoint based on the bone augmentation success (bone gain after bone augmentation procedure) measured by Cone Beam CT
15 secondary outcomes
Safety endpoint: Collection of all device related adverse events
Time frame: 4 months after procedure
Safety endpoint: Collection of all device related adverse events
Time frame: 6 months after procedure
Procedure success: ability to successfully perform the implants placement
Time frame: 4 months after procedure
Procedure success: ability to successfully perform the implants placement
Time frame: 6 months after procedure
Site preparation: need for under or over preparation of the osteotomy
Time frame: 4 months after procedure
Site preparation: need for under or over preparation of the osteotomy
Time frame: 6 months after procedure
Assessment of the bone quality and bone quantity
Time frame: 4 months after procedure
Assessment of the bone quality and bone quantity
Time frame: 6 months after procedure
Implant survival
Time frame: 1 year after after definitive prosthesis delivery
Implant success
Time frame: 1 year after after definitive prosthesis delivery
Papilla index evaluation
Time frame: 1 year after definitive prosthesis delivery
Plaque index evaluation
Time frame: 1 year after definitive prosthesis delivery
Bleeding index evaluation
Time frame: 1 year after definitive prosthesis delivery
Keratinized mucosa evaluation
Time frame: 1 year after definitive prosthesis delivery
Patient Oral health profile evaluation
Time frame: 1 year follow-up visit
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2019.
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bone graft substitute in people with Bone Loss in Jaw, run by Wishbone SA at 1 site 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 8 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: status not confirmed, as of the sponsor's last update on 21 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Measure of the bone augmentation success (time frame: 4 months after procedure). The study lists 2 primary outcomes in all. 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 21 Aug 2019.