search
Back to results

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
British University In Egypt
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Maxillary Diseases

Eligibility Criteria

20 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Healthy adult patients.
  2. Both sex, males and females.
  3. Age from 24 - 49 years old.
  4. All patients were free from any systemic diseases as evidenced by Burkett's oral medicine health history questionnaire.
  5. Extraction done at posterior maxilla involved with the maxillary sinus.
  6. Remaining alveolar bone ≤ 5mm vertically and ≥ 4mm horizontally and from 1.5 mm to 3.5 mm vertically.
  7. Gingival biotype 1-2mm thickness.
  8. Patient has no previous surgery in Maxillary antrum.

Exclusion Criteria:

  1. Smokers.
  2. Pregnant and breast-feeding females.
  3. Mentally retarded Patients.
  4. Presence of hematologic disease.
  5. Previous radiation, chemotherapy, or immunosuppressive treatments.
  6. Diabetes mellitus, metabolic bone disease, ongoing treatment with bisphosphonates drugs, or pregnancy.
  7. Patient with history of chronic sinus pathosis
  8. 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

    First Posted
    September 8, 2019
    Last Updated
    December 4, 2019
    Sponsor
    British University In Egypt
    search

    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

    Learn more about this trial

    Lateral Sinus Augmentation Using L-PRF as Sole Graft Material

    We'll reach out to this number within 24 hrs