Allogeneic Bone Paste Versus Allogeneic Bone Powder

Bone Resorption Clinical Trial

Official title:

Allogeneic Bone Paste Versus Allogeneic Bone Powder in Pre-implant Guided Bone Regeneration in Oral Surgery: a Randomized Non-inferiority Clinical Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04141215
• Other study ID #: 2019-A00488-49
• Status: Recruiting
• Phase: N/A
• Start date: November 15, 2019
• Est. completion date: November 30, 2022

Study information

• Verified date: January 2022
• Source: Biobank
• Contact: Grégoire EDORH
• Phone: +33 1 64 42 00 75
• Email: gedorh[@]biobank.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 86
• Est. completion date: November 30, 2022
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bone Resorption
• Dental Diseases
• Stomatognathic Diseases

Intervention

Biological:
• BIOBank bone paste
BIOBank bone paste (PPT322)
• BIOBank cortico-cancellous bone powder
BIOBank cortico-cancellous bone powder (PPT6)

Locations

Country	Name	City	State
France	Clinique Rive Gauche	Toulouse

Sponsors (2)

Lead Sponsor	Collaborator
Biobank	EVAMED

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Duration of surgery	measured in minutes	immediate post-operative
Secondary	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
Secondary	Absolute gain in bone volume	measured in mm by a radiographic distance	4 months post-bone grafting
Secondary	Primary osteointegration (implants stability)	measured by Implant Stability Quotient (ISQ) using Resonance frequency analysis (RFA)	4 months post-bone grafting
Secondary	Peri-implant marginal bone height	measured in mm	4 months post-bone grafting
Secondary	Survivorship of the implant	binary variable yes / no	3-4 months post-implant
Secondary	Need for a new bone augmentation simultaneously with implant placement	Binary yes/no	4 to 6 months post-bone grafting (implant placement)
Secondary	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
Secondary	Occurrence of complications related to the transplant	binary yes / no	7-10 months post-bone grafting
Secondary	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