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BMAC on PCL Scaffold for Ridge Augmentation

Primary Purpose

Bone Loss in Jaw, Edentulous Alveolar Ridge

Status
Recruiting
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
BMAC on PCL Scaffold
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Loss in Jaw focused on measuring Ridge augmentation, BMAC , PCL

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patient who require horizontal ridge augmentation in the aesthetic zone (Maxillary anterior and premolar area) with defect size of one or two lost teeth.
  • Patients in the age range of 18 years and above.
  • ASA physical status I and II.
  • Patients willing to be a part of the study and ready to give their consent in writing for the same.

Exclusion Criteria:

  • Local criteria:

    • Untreated gingivitis, periodontitis.
    • Insufficient oral hygiene.
    • Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site.

Systemic criteria:

  • Systemic disorders.
  • Smoking.
  • Bone pathology.

Sites / Locations

  • Faculty of Dentistry, Cairo universityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Intervention Group

Arm Description

Ridge augmentation of horizontally deficient alveolar ridge in aesthetic zone by BMAC on PCL scaffold

Outcomes

Primary Outcome Measures

Bone Width gain
The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters

Secondary Outcome Measures

Percentage of bone formation in the bone biopsy
Bone biopsy is obtained after 6 months and subjected to histomorphometric analysis

Full Information

First Posted
January 15, 2022
Last Updated
February 4, 2022
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT05241548
Brief Title
BMAC on PCL Scaffold for Ridge Augmentation
Official Title
Bone Marrow Aspirate Concentrate(BMAC) on 3D Printed Polycaprolactone (PCL) Scaffold for Ridge Augmentation of Horizontal Alveolar Defects in Aesthetic Zone (Clinical Case Series Study)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 15, 2022 (Actual)
Primary Completion Date
June 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
BMAC is used on 3D printed PCL scaffold for horizontal ridge augmentation in aesthetic zone , BMAC contains MSCs which can differentiate in osteogenic medium into osteoblasts which can lay down bone
Detailed Description
Alveolar bone defects were classified according to their morphology and pattern of bone loss into Class I where buccolingual loss occurs while maintaining the vertical height( Horizontal defect), Class II where vertical bone loss occurs with no buccolingual width loss (Vertical defect) and Class III where combination of vertical and horizontal bone loss occurs . These defects require augmentation before implant placement, several techniques were approached including autogenous and non autogenous bone grafting , Guided bone regeneration (GBR), ridge splitting and distraction osteogenesis. Bone grafts used with these techniques are categorized into : autografts, allografts , xenografts and alloplasts. Autogenous bone is considered to be the gold standard in grafting because it is osteogenic in nature, osteoinductive , osteoconductive and immunologically safe The autogenous bone can be harvested intraorally from the chin area, mandibular ramus, retromolar area, maxillary tuberosity, Coronoid process, zygomatic bone or palatal and mandibular tori if present . Intraoral harvesting has the advantage of good access and no need for hospitalization but the main disadvantage is the donor site morbidity and the small amount of harvested bone. Extraoral harvesting sites include the ilium, calvarium, ribs, tibia and fibula. Extraoral harvesting solved the problem of the limited amount of harvested bone graft but the main disadvantages are the need of hospitalization, performing the harvesting procedure under general anesthesia and high morbidity due to the second surgical site Recently, tissue engineering has been used for bone regeneration so called bone tissue engineering (BTE) which aims to combine the progenitor cells to differentiate into osteoblasts, growth factors needed for regenerative process and osteoconductive scaffolds for therapeutic applications. BTE involves harvesting osteogenic cells from an autologous harvesting site ( bone marrow or adipose tissue) and/or ex vivo amplification and seeding the scaffold with cells for in vivo implantation aiming to replicate the properties of autogenous bone and decrease the need for invasive harvesting Bone marrow contains a heterogenous population of progenitor cells such as Mesenchymal stem cells (MSC),hematopoietic stem cells (HSC) and endothelial progenitor cells in addition to several growth factors, including platelet-derived growth factor (PDGF), transforming growth factor-beta (TGF-b), and bone morphogenetic protein (BMP)-2 and BMP-7, which are known to have anabolic and anti-inflammatory effects. Concentration of the mononuclear cell fraction (MNC) of bone marrow aspirate ( which includes MSCs) by density gradient centrifugation process to remove erythrocytes, granulocytes, platelets and immature myeloid precursors to form Bone Marrow Aspirate Concentrate (BMAC) is considered important step in BTE. . Many clinical studies proved the use of Bone Marrow Aspirate Concentrate for treatment of osseous defects and cartilage defects due to the ability of MSCs to differentiate into osteoblasts, chondroblasts or adipocytes. The mesenchymal stem cells (MSCs) are highly biologically competent as they possess the ability to adhere on plastic (scaffolds) in vitro, form colony forming fibroblasts (CFU) and differentiate into mesenchyme lineages ( adipocytes, osteocytes, chondrocytes, tenocytes, myocytes) in addition to their potential of self renewal and promotion of hematopoiesis. Also, they suppress alloresponse after transplantation . Scaffolds are support structures used in tissue engineering to allow 3D growth of cells in an organized way and can be classified into natural (such as collagen plug) , synthetic aliphatic polyesters such as polycaprolactone (PCL), polyglycolic acid (PGA) and polylactic acid (PLA) and their copolymers and derivatives and composite scaffold which are made by combining bioceramics with polymers or xenogenic biomaterials together with bioceramics or polymers .

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bone Loss in Jaw, Edentulous Alveolar Ridge
Keywords
Ridge augmentation, BMAC , PCL

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
7 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Ridge augmentation of horizontally deficient alveolar ridge in aesthetic zone by BMAC on PCL scaffold
Intervention Type
Procedure
Intervention Name(s)
BMAC on PCL Scaffold
Intervention Description
Horizontal ridge augmentation in aesthetic zone by using bone marrow aspirate concentrate on PCL scaffold
Primary Outcome Measure Information:
Title
Bone Width gain
Description
The width of the augmented alveolar ridge measured from the Cone Beam Computed Tomography in millimeters
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Percentage of bone formation in the bone biopsy
Description
Bone biopsy is obtained after 6 months and subjected to histomorphometric analysis
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patient who require horizontal ridge augmentation in the aesthetic zone (Maxillary anterior and premolar area) with defect size of one or two lost teeth. Patients in the age range of 18 years and above. ASA physical status I and II. Patients willing to be a part of the study and ready to give their consent in writing for the same. Exclusion Criteria: Local criteria: Untreated gingivitis, periodontitis. Insufficient oral hygiene. Previous radiation therapy the head and neck neoplasia, or bone augmentation to implant site. Systemic criteria: Systemic disorders. Smoking. Bone pathology.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Alaa Hassan
Phone
00201090101125
Email
alaa.hassan@dentistry.cu.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
Aalaa Emara, PhD
Email
aalaa.emara@dentistry.cu.edu.eg
Facility Information:
Facility Name
Faculty of Dentistry, Cairo university
City
Cairo
ZIP/Postal Code
12311
Country
Egypt
Individual Site Status
Recruiting

12. IPD Sharing Statement

Citations:
PubMed Identifier
26798765
Citation
Chahla J, Dean CS, Moatshe G, Pascual-Garrido C, Serra Cruz R, LaPrade RF. Concentrated Bone Marrow Aspirate for the Treatment of Chondral Injuries and Osteoarthritis of the Knee: A Systematic Review of Outcomes. Orthop J Sports Med. 2016 Jan 13;4(1):2325967115625481. doi: 10.1177/2325967115625481. eCollection 2016 Jan.
Results Reference
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PubMed Identifier
29126349
Citation
Cotter EJ, Wang KC, Yanke AB, Chubinskaya S. Bone Marrow Aspirate Concentrate for Cartilage Defects of the Knee: From Bench to Bedside Evidence. Cartilage. 2018 Apr;9(2):161-170. doi: 10.1177/1947603517741169. Epub 2017 Nov 10.
Results Reference
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PubMed Identifier
16923606
Citation
Dominici M, Le Blanc K, Mueller I, Slaper-Cortenbach I, Marini F, Krause D, Deans R, Keating A, Prockop Dj, Horwitz E. Minimal criteria for defining multipotent mesenchymal stromal cells. The International Society for Cellular Therapy position statement. Cytotherapy. 2006;8(4):315-7. doi: 10.1080/14653240600855905.
Results Reference
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PubMed Identifier
19149628
Citation
Jager M, Jelinek EM, Wess KM, Scharfstadt A, Jacobson M, Kevy SV, Krauspe R. Bone marrow concentrate: a novel strategy for bone defect treatment. Curr Stem Cell Res Ther. 2009 Jan;4(1):34-43. doi: 10.2174/157488809787169039.
Results Reference
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PubMed Identifier
17335361
Citation
McAllister BS, Haghighat K. Bone augmentation techniques. J Periodontol. 2007 Mar;78(3):377-96. doi: 10.1902/jop.2007.060048.
Results Reference
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PubMed Identifier
31215114
Citation
Sanz M, Dahlin C, Apatzidou D, Artzi Z, Bozic D, Calciolari E, De Bruyn H, Dommisch H, Donos N, Eickholz P, Ellingsen JE, Haugen HJ, Herrera D, Lambert F, Layrolle P, Montero E, Mustafa K, Omar O, Schliephake H. Biomaterials and regenerative technologies used in bone regeneration in the craniomaxillofacial region: Consensus report of group 2 of the 15th European Workshop on Periodontology on Bone Regeneration. J Clin Periodontol. 2019 Jun;46 Suppl 21:82-91. doi: 10.1111/jcpe.13123.
Results Reference
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PubMed Identifier
6578906
Citation
Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part I. Technique and wound healing. Compend Contin Educ Dent (Lawrenceville). 1983 Sep-Oct;4(5):437-53. No abstract available.
Results Reference
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PubMed Identifier
6321099
Citation
Seibert JS. Reconstruction of deformed, partially edentulous ridges, using full thickness onlay grafts. Part II. Prosthetic/periodontal interrelationships. Compend Contin Educ Dent (Lawrenceville). 1983 Nov-Dec;4(6):549-62. No abstract available.
Results Reference
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PubMed Identifier
30623455
Citation
Shanbhag S, Suliman S, Pandis N, Stavropoulos A, Sanz M, Mustafa K. Cell therapy for orofacial bone regeneration: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:162-182. doi: 10.1111/jcpe.13049.
Results Reference
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BMAC on PCL Scaffold for Ridge Augmentation

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