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Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (MPM)

Primary Purpose

Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
autogenous bone
Mineralized plasmatic matrix
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bone Resorption

Eligibility Criteria

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

Inclusion Criteria:

  1. Patients systemically free.
  2. Patients with posterior maxillary defective ridges indicated for sinus lift procedure.
  3. Cases with 5 mm bone height or less are included in the study.
  4. Age between 18 and 50 years.
  5. Both sexes.
  6. Patients physically able to tolerate surgical and restorative procedures.
  7. Good oral hygiene.
  8. Highly motivated patients.

Exclusion Criteria:

  1. Patients allergic to local anesthetic agent.
  2. Medium and heavy smokers.
  3. Pregnant females.
  4. Presence of any pathosis in the pre-implant site.
  5. Presence of any mucosal disease.
  6. History of oral radiotherapy.
  7. History of prolonged steroids use.
  8. Psychological disorders.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Autogenous bone graft (Gold Standard).

    Mineralized Plasmatic Matrix (MPM)

    Arm Description

    Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.

    Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.

    Outcomes

    Primary Outcome Measures

    Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
    outcome will be measure using questionnaire.

    Secondary Outcome Measures

    Stability of dental implants.
    will be measured using OSTELL Device.

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    January 5, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03014388
    Brief Title
    Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
    Acronym
    MPM
    Official Title
    Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    December 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    January 2017 (undefined)
    Primary Completion Date
    September 2017 (Anticipated)
    Study Completion Date
    October 2017 (Anticipated)

    3. Sponsor/Collaborators

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

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    Using growth factors obtained from patient's venous blood mixed with particulate autogenous bone the study compares bone gain by implant with gold standards in sinus Lift procedures for future implant insertion.
    Detailed Description
    To study the effectiveness of MPM in ridge augmentation with implant insertion compared with autogenous bone graft. -PICO Population(P) : Patients with defective posterior maxillary alveolar ridge. Intervention (I) :Implant placement and ridge augmentation with MPM. Comparator (C) : Autogenous bone graft. Outcome (O) : Patient satisfaction - Implant stability.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Bone Resorption

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Autogenous bone graft (Gold Standard).
    Arm Type
    Experimental
    Arm Description
    Patients with defective posterior maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and to be used for bone augmentation with sinus lift.
    Arm Title
    Mineralized Plasmatic Matrix (MPM)
    Arm Type
    Experimental
    Arm Description
    Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.
    Intervention Type
    Other
    Intervention Name(s)
    autogenous bone
    Other Intervention Name(s)
    Autobone
    Intervention Description
    Autogenous bone graft (gold standard). sinus lift with autogenous bone.
    Intervention Type
    Other
    Intervention Name(s)
    Mineralized plasmatic matrix
    Other Intervention Name(s)
    MPM
    Intervention Description
    By using venoud blood from the patient, together with bone graft, a centrifuge will be used to obtain the top layer after centrifuging blood at 3000 RPM.
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction regarding aesthetic results will be measured using questionnaire.
    Description
    outcome will be measure using questionnaire.
    Time Frame
    9 months
    Secondary Outcome Measure Information:
    Title
    Stability of dental implants.
    Description
    will be measured using OSTELL Device.
    Time Frame
    5 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: Patients systemically free. Patients with posterior maxillary defective ridges indicated for sinus lift procedure. Cases with 5 mm bone height or less are included in the study. Age between 18 and 50 years. Both sexes. Patients physically able to tolerate surgical and restorative procedures. Good oral hygiene. Highly motivated patients. Exclusion Criteria: Patients allergic to local anesthetic agent. Medium and heavy smokers. Pregnant females. Presence of any pathosis in the pre-implant site. Presence of any mucosal disease. History of oral radiotherapy. History of prolonged steroids use. Psychological disorders.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    refaat ragab, Master
    Phone
    01111175536
    Email
    refaat.ragab.rr@gmail.com
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Cairo University CBE
    Organizational Affiliation
    Cairo University - Ethics Committee.
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No
    IPD Sharing Plan Description
    Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.

    Learn more about this trial

    Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft

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