Allogeneic Bone Paste Versus Allogeneic Bone Powder

NCT04141215 | Unknown

• 1 other identifier: 2019-A00488-49
• Study Type: interventional
• Target: 86
• Locations: 1 country
• Sites: 1

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.

Conditions

Bone Resorption; Dental Diseases

Outcome Measures

Primary Outcomes (1)

• 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.

  4 to 6 months post-bone grafting

Secondary Outcomes (10)

• Duration of surgery

  immediate post-operative

• Ease of manipulation

  immediate post-bone grafting

• Absolute gain in bone volume

  4 months post-bone grafting

• Primary osteointegration (implants stability)

  4 months post-bone grafting

• Peri-implant marginal bone height

  4 months post-bone grafting

Study Arms (2)

BIOBank bone paste (PPT322)

EXPERIMENTAL

Allogeneic bone paste derived from human living donor femoral heads

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)

Biological: BIOBank cortico-cancellous bone powder

Interventions

BIOBank bone paste BIOLOGICAL

BIOBank bone paste (PPT322)

BIOBank bone paste (PPT322)

BIOBank cortico-cancellous bone powder BIOLOGICAL

BIOBank cortico-cancellous bone powder (PPT6)

BIOBank cortico-cancellous bone powder (PPT6)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• Biobank: lead
• EVAMED: collaborator

Study Sites (1)

Clinique Rive Gauche

Toulouse, 31100, France

RECRUITING

Related Publications (1)

• Courtois B, L'Homme A, Labadie MP. Allogeneic bone paste versus bone powder for oral guided bone regeneration: A randomized, noninferiority trial. J Periodontol. 2025 Oct 29. doi: 10.1002/jper.11385. Online ahead of print.

  PMID: 41159915 DERIVED

MeSH Terms

Conditions

Bone Resorption; Stomatognathic Diseases

Condition Hierarchy (Ancestors)

Bone Diseases; Musculoskeletal Diseases

Study Officials

• Bruno Courtois, Dr

  Clinique Rive Gauche (TOULOUSE)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Grégoire EDORH

CONTACT

+33 1 64 42 00 75; gedorh@biobank.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Statistician will also perform trial analyses with treatment masking
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: October 23, 2019
• First Posted: October 28, 2019
• Study Start: November 15, 2019
• Primary Completion: November 30, 2022
• Study Completion: November 30, 2022
• Last Updated: March 2, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)