- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03757195
Augmentation of Maxillary Horizontal And Vertical Bone Deficiency Using Mineralized Plasmatic Matrix
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).
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Recruiting
- Cairo Univerisity
-
Contact:
- Hany M Ahmed, BDS
- Phone Number: 00201091971228
- Email: hanyyusf4@gmail.com
-
Cairo, Egypt
- Not yet recruiting
- Cairo University
-
Contact:
- Tarek I. Abdallah, P.H.D
-
Principal Investigator:
- Hany M. Ahmed, B.D.S
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 .
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: augmentation by xenograft
xenograft mixed with plasma extracted from blood
|
combination product
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
amount of bone loss
Time Frame: change from baseline at 6 months
|
amount of bone loss after xenograft by CBCT
|
change from baseline at 6 months
|
Collaborators and Investigators
Sponsor
Investigators
- Study Director: Tarek I. Abdallah, P.H.D, Cairo University
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CEBC-CU-2017-11-16
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Alveolar Ridge Abnormality of Maxilla
-
Cairo UniversityUnknown
-
Nobel BiocareCompletedAlveolar Ridge AbnormalityUnited States
-
Shahid Beheshti University of Medical SciencesCompletedCleft of Alveolar RidgeIran, Islamic Republic of
-
Cairo UniversityUnknownCleft of Alveolar RidgeEgypt
-
Ivory Graft Ltd.CompletedAlveolar Bone Grafting | Deficiency of Alveolar Ridge (Disorder) | Mandibular Prosthesis UserIsrael
-
Ivory Graft Ltd.Active, not recruitingAlveolar Bone Grafting | Deficiency of Alveolar Ridge (Disorder) | Mandibular Prosthesis UserIsrael
-
Cairo UniversityNot yet recruitingSocket Preservation, Alveolar Ridge Deficiency, Alveolar Ridge Preservation
-
University of Alabama at BirminghamCompletedAlveolar Ridge Preservation | Alveolar Ridge AugmentationUnited States
-
Cliniques universitaires Saint-Luc- Université...Geistlich Pharma AGRecruitingAlveolar Ridge AugmentationBelgium
-
Yasmine FouadCompletedAlveolar Ridge Preservation
Clinical Trials on Augmentation
-
Shirley Ryan AbilityLabU.S. Department of EducationCompleted
-
University of BernSonnenhof Hospital, BernTerminatedOsteoporosis | Vertebral FractureSwitzerland
-
Universidad Científica del SurNYU Langone HealthCompletedDental Implants | Bone Regeneration | Cone-beam Computed Tomography | Bone Substitutes | Bone TransplantationPeru
-
University Hospital of FerraraUniversity of Modena and Reggio EmiliaCompleted
-
The Catholic University of KoreaUnknown
-
McGill UniversityCanadian Institutes of Health Research (CIHR); Centre for Interdisciplinary... and other collaboratorsNot yet recruitingCognitive Impairment | Stroke, Ischemic | Stroke Hemorrhagic
-
Universidad Complutense de MadridOsteology FoundationRecruitingDental Malocclusion | Maxillary DeficiencySpain
-
DFINE Inc.WithdrawnMultiple Myeloma | Compression Fracture of Vertebral Column
-
Queen Mary University of LondonGeistlich Pharma AGRecruitingTooth Loss | Wound Heal | Dental DiseasesUnited Kingdom
-
Nexilis AGTerminatedOsteoporotic Fracture of VertebraAustria