Bone ResorptionNCT04141215
Allogeneic Bone Paste Versus Allogeneic Bone Powder
A study testing BIOBank bone paste and BIOBank cortico-cancellous bone powder in people with Bone Resorption and Dental Diseases, run by Biobank at 1 site in France.
Trial summary
Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bone Resorption, Dental Diseases
- What is being tested?
- BIOBank bone paste and BIOBank cortico-cancellous bone powder
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteFrance
- Study dates
- 15 Nov 2019to 30 Nov 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient aged ≥ 18 years old
- Patient able to read, understand and give written consent to participate in the study
- Patient affiliated with a social security system or beneficiary of such a system
- Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume
- Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants
- Possibility of acquisition by CBCT for the required protocol visits
Who cannot join
- General contraindication to bone graft and implant surgery
- Pregnant woman or planned pregnancy during the study period or breast-feeding woman;
- Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material
- Patient who received less than 3 months ago a CBCT acquisition at the operative site
- Patient simultaneously requiring more than one GBR augmentation in the same quadrant
- Patient with signs of local infection at the targeted graft site
Show all 11Show fewer
- Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes)
- Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing
- Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces)
- Patient smoker of more than 10 cigarettes a day
- Any other condition that, in the investigator's opinion, would be detrimental to the safety of the patient or fail to meet the requirements of the protocol
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Clinique Rive Gauche
Toulouse, 31100
Bruno Courtois, +33 5 62 89 99 30, brunocourtois.co@gmail.com
About this study
Official title: Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial
Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.
- Conditions
- Bone Resorption, Dental Diseases
- Being tested
- BIOBank bone paste, BIOBank cortico-cancellous bone powder
- Medical subject headings
- Bone Resorption, Stomatognathic Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BIOBank bone pasteBiological
BIOBank bone paste (PPT322)
BIOBank cortico-cancellous bone powderBiological
BIOBank cortico-cancellous bone powder (PPT6)
| Study group | Role | What they receive |
|---|---|---|
| BIOBank bone paste (PPT322) | Experimental | Allogeneic bone paste derived from human living donor femoral heads Receives: Biological: BIOBank bone paste |
| BIOBank cortico-cancellous bone powder (PPT6) | Active comparator | Allogeneic bone powder derived from human living donor femoral heads (used in current practice) Receives: Biological: BIOBank cortico-cancellous bone powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bone volume obtained
The primary endpoint is binary in nature (yes / no) and assessed radiographically by the CBCT: To assess, 4 to 6 months post-transplant, if the bone volume obtained at the time of implant placement corresponds to the desired bone volume before the transplant.
Measured by an independent Evaluator, blind to the treatment received.
Measured: 4 to 6 months post-bone grafting
Secondary outcomes (10)
Duration of surgery
measured in minutes
Measured: immediate post-operative
Ease of manipulation
assessed by the operating surgeon using a Visual Analogue Scale from 0 (Not easy at all) to 10 (Very easy)
Measured: immediate post-bone grafting
Absolute gain in bone volume
measured in mm by a radiographic distance
Measured: 4 months post-bone grafting
Primary osteointegration (implants stability)
measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)
Measured: 4 months post-bone grafting
Peri-implant marginal bone height
measured in mm
Measured: 4 months post-bone grafting
Survivorship of the implant
binary variable yes / no
Measured: 3-4 months post-implant
Need for a new bone augmentation simultaneously with implant placement
Binary yes/no
Measured: 4 to 6 months post-bone grafting (implant placement)
Insufficient primary stability of the implant
Implant Stability Quotient (ISQ) less than 35N
Measured: 4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant
Occurrence of complications related to the transplant
binary yes / no
Measured: 7-10 months post-bone grafting
Nature of possible complications or a thematic grouping in the inter-group comparison
All complications appeared from the bone grafting until the end of the study will be described overall and by arm and grouped by thematic if relevant.
Measured: 7-10 months post-bone grafting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2019
- Study start15 Nov 2019
- Primary completion30 Nov 2022 (estimated)
- Study completion30 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bone ResorptionStudies 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
- Randomized non-inferiority, two-arm, parallel, single-blind and monocentric clinical trial: 1. BIOBank bone paste (PPT322), derived from human living donor femoral heads 2. BIOBank cortico-cancellous bone powder (PPT6), derived from human living donor femoral heads, used in current practice as reference treatment
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 86 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biobank
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Responsible party
- Sponsor
- Investigators
- Bruno Courtois, Dr, Principal investigator, Clinique Rive Gauche (TOULOUSE)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04141215
- Sponsor's protocol ID
- 2019-A00488-49
- Status last verified
- Jan 2022
- First submitted
- 23 Oct 2019
- Last updated
- 2 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Courtois B, L'Homme A, Labadie MP. Allogeneic bone paste versus bone powder for oral guided bone regeneration: A randomized, noninferiority trial. J Periodontol. 2026 Mar;97(3):411-421. doi: 10.1002/jper.11385. Epub 2025 Oct 29.
PubMed 41159915
Study at a glance
From the registry record, last updated by the sponsor on 2 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial
- ClinicalTrials.gov ID
- NCT04141215
- Acronym / sponsor ID
- 2019-A00488-49
- Conditions
- Bone Resorption, Dental Diseases
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 86 participants (estimated)
- Lead sponsor
- BiobankIndustry (pharma, biotech, devices)
- Collaborators
- EVAMED
- Study start
- 15 Nov 2019 (actual)
- Primary completion
- 30 Nov 2022 (estimated)
- Study completion
- 30 Nov 2022 (estimated)
- First posted
- 28 Oct 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.
Autogenous bone graft has been considered the gold standard in Guided Bone Regeneration (GBR) technique used for bone augmentation. However, there are disadvantages associated with autograft use such as limited amount of available bone and increased morbidity for the patient at the sampling site. Several biomaterials have been used as a replacement of the autogenous bone. Viral-inactivated bone allograft powder is an alternative that has proven efficacy and tolerance. This study aims to assess the non-inferiority of viral-inactivated allogeneic bone paste compared to a viral-inactivated cortico-cancellous allogenic bone powder in achieving the ideal bone volume.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized non-inferiority, two-arm, parallel, single-blind and monocentric clinical trial: 1. BIOBank bone paste (PPT322), derived from human living donor femoral heads 2. BIOBank cortico-cancellous bone powder (PPT6), derived from human living donor femoral heads, used in current practice as reference treatment
| Arm | Type | Receives |
|---|---|---|
| BIOBank bone paste (PPT322) | Experimental | Biological: BIOBank bone pasteAllogeneic bone paste derived from human living donor femoral heads |
| BIOBank cortico-cancellous bone powder (PPT6) | Active comparator | Biological: BIOBank cortico-cancellous bone powderAllogeneic bone powder derived from human living donor femoral heads (used in current practice) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Patient aged ≥ 18 years old
- Patient able to read, understand and give written consent to participate in the study
- Patient affiliated with a social security system or beneficiary of such a system
- Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume
- Presence of a bone deficit requiring horizontal and / or vertical bone augmentation (stage 4 or 5 of the Benic and Hammerle classification) treated by GBR for delayed placement of up to 4 dental implants
Key exclusion criteria (11 listed)
- General contraindication to bone graft and implant surgery
- Pregnant woman or planned pregnancy during the study period or breast-feeding woman;
- Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material
- Patient who received less than 3 months ago a CBCT acquisition at the operative site
- Patient simultaneously requiring more than one GBR augmentation in the same quadrant
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 |
|---|---|---|
| BIOBank bone pasteBIOBank bone paste (PPT322) | Biological | BIOBank bone paste (PPT322) |
| BIOBank cortico-cancellous bone powderBIOBank cortico-cancellous bone powder (PPT6) | Biological | BIOBank cortico-cancellous bone powder (PPT6) |
Primary outcome
Bone volume obtained
Time frame: 4 to 6 months post-bone grafting
The primary endpoint is binary in nature (yes / no) and assessed radiographically by the CBCT: To assess, 4 to 6 months post-transplant, if the bone volume obtained at the time of implant placement corresponds to the desired bone volume before the transplant. Measured by an independent Evaluator, blind to the treatment received.
10 secondary outcomes
Duration of surgery
Time frame: immediate post-operative
Ease of manipulation
Time frame: immediate post-bone grafting
Absolute gain in bone volume
Time frame: 4 months post-bone grafting
Primary osteointegration (implants stability)
Time frame: 4 months post-bone grafting
Peri-implant marginal bone height
Time frame: 4 months post-bone grafting
Survivorship of the implant
Time frame: 3-4 months post-implant
Need for a new bone augmentation simultaneously with implant placement
Time frame: 4 to 6 months post-bone grafting (implant placement)
Insufficient primary stability of the implant
Time frame: 4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant
Occurrence of complications related to the transplant
Time frame: 7-10 months post-bone grafting
Nature of possible complications or a thematic grouping in the inter-group comparison
Time frame: 7-10 months post-bone grafting
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Mar 2022.
- Derived from this study: PubMed 41159915Courtois B, L'Homme A, Labadie MP. Allogeneic bone paste versus bone powder for oral guided bone regeneration: A randomized, noninferiority trial. J Periodontol. 2026 Mar;97(3):411-421. doi: 10.1002/jper.11385. Epub 2025 Oct 29.
- Individual participant dataSharing planned: No
Related trials for Bone Resorption
RecruitingPhase 1
Veverimer to Decrease Net Acid Excretion and Bone Resorption in Adults With Osteopenia
Osteopenia
RecruitingObservational study
A Prospective Natural History Study of Lymphatic Anomalies
Lymphatic Diseases, Lymphatic Abnormalities
Recruiting
Effect of Collagen Membrane on Ridge Preservation
Dehiscence, Tooth Extraction
Not yet recruitingPhase 1/2
Alveolar Ridge Preservation (ARP) Study Using Alloplastic Biomaterial and a Resorbable Synthetic Membrane. A Digital Workflow (CBCT/Scanner) Evaluates Hard and Soft Tissue Volumetric Changes at 4 Months, Validating Support for the Gingival Phenotype and Buccal Bone Plate.
Alveolar Ridge Augmentation, Bone Substitutes
Recruiting
Melatonin Effect on Immediate Dental Implants in the Posterior Mandible
Dental Implant, Immediate Dental Implant Placement
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.
Bruno Courtois, Dr principal investigator
Clinique Rive Gauche (TOULOUSE)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BIOBank bone paste and BIOBank cortico-cancellous bone powder in people with Bone Resorption and Dental Diseases, run by Biobank at 1 site in France.
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 6 inclusion and 11 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 2 Mar 2022. 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 France. 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?
Contact Grégoire EDORH (+33 1 64 42 00 75, gedorh@biobank.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bone volume obtained (time frame: 4 to 6 months post-bone grafting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04141215, which also lists 1 linked publication.
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 2 Mar 2022.