Allogeneic Bone Paste Versus Allogeneic Bone Powder

Biobank

Status: Unknown

Conditions: Dental Diseases; Bone Resorption

Treatments: Biological: BIOBank bone paste; Biological: BIOBank cortico-cancellous bone powder

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04141215

2019-A00488-49

Details and patient eligibility

About

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.

Enrollment: 86 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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86 participants in 2 patient groups

BIOBank bone paste (PPT322)

Experimental group

Description:

Allogeneic bone paste derived from human living donor femoral heads

Treatment:

Biological: BIOBank bone paste

BIOBank cortico-cancellous bone powder (PPT6)

Active Comparator group

Description:

Allogeneic bone powder derived from human living donor femoral heads (used in current practice)

Treatment:

Biological: BIOBank cortico-cancellous bone powder