Back to resultsAugmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
Primary Purpose
Alveolar Ridge Abnormality of Maxilla
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Augmentation
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Ridge Abnormality of Maxilla focused on measuring Mineralized plasmatic matrix, sticky bone, plasma, autogeous fibrin glue
Eligibility Criteria
Inclusion Criteria:
- Age: from 20 to 40 years old
- no history of previous grafting.
- no History of previous implant placement
- Medically Free e.g no debilitating diseases
Exclusion Criteria:
- Smoker patients.
- Alcoholic patients
- Pregnant.
- Drug Abusers.
- Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.
- Thyroid Disease.
- Problem in Vit.D absorption or in calcitonin hormone secretion.
- History of blood transfusion or donating blood less than 4 months.
- Patient under Corticosteroid therapy.
- Neurologicaly unstable patients.
- History of radiotherapy or chemo-therapy.
- Patient undergo Spect C.T Scan less than 4 Months .
Sites / Locations
- Cairo UniverisityRecruiting
- Cairo University
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
augmentation by xenograft
Arm Description
xenograft mixed with plasma extracted from blood
Outcomes
Primary Outcome Measures
amount of bone loss
amount of bone loss after xenograft by CBCT
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03757195
Brief Title
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
Official Title
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
Study Type
Interventional
2. Study Status
Record Verification Date
November 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 15, 2018 (Actual)
Primary Completion Date
July 29, 2020 (Anticipated)
Study Completion Date
October 25, 2020 (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
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
A new technique of grafting introduce called Mineralized plasmatic matrix. This technique can be used in grafting in anterior zone giving a good results and bone substitution occur using allograft or xenograft.
The bone graft have a good consistency when it mixed with plasma give easy application, strength and stability of the graft. Also plasma rich with CGF (Cellular growth factors).
Detailed Description
Patients suffering from anterior maxillary vertical and horizontal bone loss will be treated using a xeno-graft mixed with the same patient plasma that extracted from his own blood during the operation this graft will be stabilized by collagen membrane and surgical tags.
Patients will be follow up for 6 months to measure amount of bone loss of the xeno-graft during this period post operative using C.B.C.T
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Ridge Abnormality of Maxilla
Keywords
Mineralized plasmatic matrix, sticky bone, plasma, autogeous fibrin glue
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
28 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
augmentation by xenograft
Arm Type
Experimental
Arm Description
xenograft mixed with plasma extracted from blood
Intervention Type
Procedure
Intervention Name(s)
Augmentation
Intervention Description
combination product
Primary Outcome Measure Information:
Title
amount of bone loss
Description
amount of bone loss after xenograft by CBCT
Time Frame
change from baseline at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age: from 20 to 40 years old
no history of previous grafting.
no History of previous implant placement
Medically Free e.g no debilitating diseases
Exclusion Criteria:
Smoker patients.
Alcoholic patients
Pregnant.
Drug Abusers.
Hypertensive , Diabetic, having Problems or disease in Kidney and/or liver.
Thyroid Disease.
Problem in Vit.D absorption or in calcitonin hormone secretion.
History of blood transfusion or donating blood less than 4 months.
Patient under Corticosteroid therapy.
Neurologicaly unstable patients.
History of radiotherapy or chemo-therapy.
Patient undergo Spect C.T Scan less than 4 Months .
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Hany M Ahmed, B.D.S
Phone
00201091971228
Email
hanyyusf4@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek I Abdallah, P.H.D
Phone
01282931864
Email
t_ghareeb@hotmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek I. Abdallah, P.H.D
Organizational Affiliation
Cairo University
Official's Role
Study Director
Facility Information:
Facility Name
Cairo Univerisity
City
Cairo
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hany M Ahmed, BDS
Phone
00201091971228
Email
hanyyusf4@gmail.com
Facility Name
Cairo University
City
Cairo
Country
Egypt
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tarek I. Abdallah, P.H.D
First Name & Middle Initial & Last Name & Degree
Hany M. Ahmed, B.D.S
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
We'll reach out to this number within 24 hrs