Clinical trial NCT04141215: Allogeneic Bone Paste Versus Allogeneic Bone Powder
Official title: Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Bone Resorption
Dental Diseases
Lead sponsor: Biobank
Sponsor class: INDUSTRY
Collaborators: name: EVAMED
First posted: 2019-10-28
Enrollment: 86
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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
Primary purpose: TREATMENT

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

1. Patient aged ≥ 18 years old
2. Patient able to read, understand and give written consent to participate in the study
3. Patient affiliated with a social security system or beneficiary of such a system
4. Partially edentulous patient with 1 to 2 intercalary missing teeth or a terminal gap with distal vertical and lateral support bone volume
5. 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
6. Possibility of acquisition by CBCT for the required protocol visits

Exclusion Criteria:

1. General contraindication to bone graft and implant surgery
2. Pregnant woman or planned pregnancy during the study period or breast-feeding woman;
3. Patient who has had a bone augmentation by GBR during the previous 12 months, in the area targeted for filling with the allogeneic material
4. Patient who received less than 3 months ago a CBCT acquisition at the operative site
5. Patient simultaneously requiring more than one GBR augmentation in the same quadrant
6. Patient with signs of local infection at the targeted graft site
7. Systemic, metabolic or autoimmune disease that may adversely affect healing of soft and bone tissue (eg, unbalanced type 1 or type 2 diabetes)
8. Use of treatments (chemotherapy or radiotherapy) or drugs (bisphosphonates, chronic steroids) known to potentially interfere with tissue healing
9. Patient presenting a dental plaque objectified by an oral examination (Loe SILNESS ≥ 2 on more than 50% of the dental surfaces)
10. Patient smoker of more than 10 cigarettes a day
11. 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

Primary outcomes:
measure: Bone volume obtained
timeFrame: 4 to 6 months post-bone grafting
Secondary outcomes:
measure: Duration of surgery
timeFrame: immediate post-operative
measure: Ease of manipulation
timeFrame: immediate post-bone grafting
measure: Absolute gain in bone volume
timeFrame: 4 months post-bone grafting
measure: Primary osteointegration (implants stability)
timeFrame: 4 months post-bone grafting
measure: Peri-implant marginal bone height
timeFrame: 4 months post-bone grafting
measure: Survivorship of the implant
timeFrame: 3-4 months post-implant
measure: Need for a new bone augmentation simultaneously with implant placement
timeFrame: 4 to 6 months post-bone grafting (implant placement)
measure: Insufficient primary stability of the implant
timeFrame: 4 to 6 months post-bone grafting (implant placement) and 3-4 months post-implant
measure: Occurrence of complications related to the transplant
timeFrame: 7-10 months post-bone grafting
measure: Nature of possible complications or a thematic grouping in the inter-group comparison
timeFrame: 7-10 months post-bone grafting
Other outcomes:
Locations:
city: Toulouse
country: France
facility: Clinique Rive Gauche
Study officials:
affiliation: Clinique Rive Gauche (TOULOUSE)
name: Bruno Courtois, Dr
role: PRINCIPAL_INVESTIGATOR
References: