Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
Primary Purpose
Maxillary Diseases
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
L-PRF
L-PRF mixed with xenograft
xenograft
Sponsored by
About this trial
This is an interventional treatment trial for Maxillary Diseases
Eligibility Criteria
Inclusion Criteria:
- Healthy adult patients.
- Both sex, males and females.
- Age from 24 - 49 years old.
- All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
- Extraction done at posterior maxilla involved with the maxillary sinus.
- Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
- Gingival biotype 1-2mm thickness.
- Patient has no previous surgery in Maxillary antrum.
Exclusion Criteria:
- Smokers.
- Pregnant and breast-feeding females.
- Mentally retarded Patients.
- Presence of hematologic disease.
- Previous radiation, chemotherapy, or immunosuppressive treatments.
- Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
- Patient with history of chronic sinus pathosis
- Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Experimental
Arm Label
L-PRF as sole graft material
xenograft as sole graft material
Xenograft mixed with L-PRF as graft material
Arm Description
lateral sinus augmentation using L-PRF as sole graft material
lateral sinus augmentation using xenograft as sole graft material
lateral sinus augmentation using L-PRF mixed with xenograft as graft material
Outcomes
Primary Outcome Measures
histomorphometric analysis
After three months from sinus augmentation, a second surgery will be done for implant placement; during this procedure, a bone core biopsy will be harvested. The biopsy will be stained with mason stain for histomorphometric analysis. The aim is to measure the newly formed bone for three months.
Secondary Outcome Measures
Full Information
NCT ID
NCT04160780
First Posted
September 8, 2019
Last Updated
December 4, 2019
Sponsor
British University In Egypt
1. Study Identification
Unique Protocol Identification Number
NCT04160780
Brief Title
Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
Official Title
Lateral Sinus Augmentation Using L-PRF and Xenograft: Radiographic and Histomorphometry Analysis.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
March 26, 2016 (Actual)
Primary Completion Date
March 1, 2019 (Actual)
Study Completion Date
April 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
British University In Egypt
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
Severe maxillary atrophy occurs after extraction of teeth in poster maxilla due to dimensional changes occur after removal; besides, sinus membrane pneumatization causes alveolar bone resorption, different classification for remaining alveolar bone in the posterior maxilla were done. In this study, the ABC sinus classification was followed in case selection. A sinus augmentation is done with several techniques. Sinus membrane elevation is done with two different approaches, either the crestal approach or lateral window approach.
Using biofiller material for sinus membrane elevation has been tried by many researchers, using a bone graft, platelet concentrates preparation, collagen membranes, tenting screws, or with implant tenting.
In this study, sinus augmentation was performed using a lateral window approach using L-PRF as sole biofiller material in one group, xenograft as only biofiller material in the second group and mixed xenograft with L-PRF in the third group. Histomorphometric analysis was done from the core biopsy after three months of augmentation, and implant placement was done.
After three months, prosthetic parts were placed. The results of this study show that the augmentation of the sinus using L-PRF mixed with bone graft is showing the best results followed by L-PRF only, and the least was xenograft.
From this point of discussion, it can be considered that using L-PRF as sole biofiller material in sinus augmentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Maxillary Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)
8. Arms, Groups, and Interventions
Arm Title
L-PRF as sole graft material
Arm Type
Experimental
Arm Description
lateral sinus augmentation using L-PRF as sole graft material
Arm Title
xenograft as sole graft material
Arm Type
Experimental
Arm Description
lateral sinus augmentation using xenograft as sole graft material
Arm Title
Xenograft mixed with L-PRF as graft material
Arm Type
Experimental
Arm Description
lateral sinus augmentation using L-PRF mixed with xenograft as graft material
Intervention Type
Procedure
Intervention Name(s)
L-PRF
Intervention Description
sinus augmentation using L-PRf as sole graft material
Intervention Type
Procedure
Intervention Name(s)
L-PRF mixed with xenograft
Intervention Description
sinus augmentation using L-PRF mixed with xenograft as sole graft material
Intervention Type
Procedure
Intervention Name(s)
xenograft
Intervention Description
sinus augmentation using xenograft as sole graft material
Primary Outcome Measure Information:
Title
histomorphometric analysis
Description
After three months from sinus augmentation, a second surgery will be done for implant placement; during this procedure, a bone core biopsy will be harvested. The biopsy will be stained with mason stain for histomorphometric analysis. The aim is to measure the newly formed bone for three months.
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Healthy adult patients.
Both sex, males and females.
Age from 24 - 49 years old.
All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
Extraction done at posterior maxilla involved with the maxillary sinus.
Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
Gingival biotype 1-2mm thickness.
Patient has no previous surgery in Maxillary antrum.
Exclusion Criteria:
Smokers.
Pregnant and breast-feeding females.
Mentally retarded Patients.
Presence of hematologic disease.
Previous radiation, chemotherapy, or immunosuppressive treatments.
Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
Patient with history of chronic sinus pathosis
Anticoagulant drugs, Endocarditis risk factors, renal and hepatic failure.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Lateral Sinus Augmentation Using L-PRF as Sole Graft Material
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