Allogeneic Bone Paste Versus Allogeneic Bone Powder

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.

Study Overview

• Status: Recruiting
• Conditions: Bone Resorption; Dental Diseases
• Intervention / Treatment: Biological: BIOBank bone paste; Biological: BIOBank cortico-cancellous bone powder

• Study Type: Interventional
• Enrollment (Anticipated): 86
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Grégoire EDORH; Phone Number: +33 1 64 42 00 75; Email: gedorh@biobank.fr

Study Locations

• France
  • Toulouse, France, 31100
    • Recruiting
    • Clinique Rive Gauche
    • Contact: Bruno Courtois; Phone Number: +33 5 62 89 99 30; Email: brunocourtois.co@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BIOBank bone paste (PPT322); Allogeneic bone paste derived from human living donor femoral heads	Biological: BIOBank bone paste; BIOBank bone paste (PPT322)
ACTIVE_COMPARATOR: BIOBank cortico-cancellous bone powder (PPT6); Allogeneic bone powder derived from human living donor femoral heads (used in current practice)	Biological: BIOBank cortico-cancellous bone powder; BIOBank cortico-cancellous bone powder (PPT6)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of surgery	measured in minutes	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)	immediate post-bone grafting
Absolute gain in bone volume	measured in mm by a radiographic distance	4 months post-bone grafting
Primary osteointegration (implants stability)	measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)	4 months post-bone grafting
Peri-implant marginal bone height	measured in mm	4 months post-bone grafting
Survivorship of the implant	binary variable yes / no	3-4 months post-implant
Need for a new bone augmentation simultaneously with implant placement	Binary yes/no	4 to 6 months post-bone grafting (implant placement)
Insufficient primary stability of the implant	Implant Stability Quotient (ISQ) less than 35N	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	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.	7-10 months post-bone grafting

Collaborators and Investigators

• Sponsor: Biobank
• Collaborators: EVAMED
• Investigators: Principal Investigator: Bruno Courtois, Dr, Clinique Rive Gauche (TOULOUSE)

Study record dates

Study Major Dates

• Study Start (ACTUAL): November 15, 2019
• Primary Completion (ANTICIPATED): November 30, 2022
• Study Completion (ANTICIPATED): November 30, 2022

Study Registration Dates

• First Submitted: October 23, 2019
• First Submitted That Met QC Criteria: October 24, 2019
• First Posted (ACTUAL): October 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): March 2, 2022
• Last Update Submitted That Met QC Criteria: March 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Bone Diseases; Bone Resorption; Stomatognathic Diseases
• Other Study ID Numbers: 2019-A00488-49

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No