Allogeneic Bone Paste Versus Allogeneic Bone Powder

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-15

Study Completion Date

2022-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Bone Resorption Dental Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Statistician will also perform trial analyses with treatment masking

Study Groups

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BIOBank bone paste (PPT322)

Allogeneic bone paste derived from human living donor femoral heads

Group Type EXPERIMENTAL

BIOBank bone paste

Intervention Type BIOLOGICAL

BIOBank bone paste (PPT322)

BIOBank cortico-cancellous bone powder (PPT6)

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

Group Type ACTIVE_COMPARATOR

BIOBank cortico-cancellous bone powder

Intervention Type BIOLOGICAL

BIOBank cortico-cancellous bone powder (PPT6)

Interventions

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BIOBank bone paste

BIOBank bone paste (PPT322)

Intervention Type BIOLOGICAL

BIOBank cortico-cancellous bone powder

BIOBank cortico-cancellous bone powder (PPT6)

Intervention Type BIOLOGICAL

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No