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Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

Primary Purpose

Bone Resorption

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Mineralized plasmatic matrix (MPM).
Autogenous bone graft (gold standard).
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 - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Medically free patients.
  2. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm)
  3. Patients with Anterior maxillary defective partially edentulous ridge.
  4. Age between 18 and 40 years.
  5. Both sexes.
  6. Patients physically able to tolerate surgical and restorative procedures.
  7. Patients with an opposing tooth to the pre-implant site.
  8. Good oral hygiene.
  9. Highly motivated patients.

Exclusion Criteria:

  1. Patients allergic to local anesthetic agent.
  2. Pregnant or lactating females.
  3. Presence of any pathosis in the pre-implant site.
  4. Presence of any mucosal disease.
  5. Presence of parafunctional habits.
  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

    Active Comparator

    Arm Label

    Autogenous bone graft (Gold Standard).

    MPM Augmentation.

    Arm Description

    Patients with defective maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.

    Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.

    Outcomes

    Primary Outcome Measures

    Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.

    Secondary Outcome Measures

    Stability of dental implants , this will be measured using Ostell device in ISQ units.

    Full Information

    First Posted
    December 25, 2016
    Last Updated
    December 30, 2016
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03007069
    Brief Title
    Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft
    Official Title
    Implant Insertion in Defective Anterior Maxillary Ridge Augmented Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
    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
    December 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.
    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 maxillary alveolar ridge requiring implant insertion. Intervention (I): 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 maxillary alveolar ridges requiring implant insertion will have Autogenous bone graft (Gold standard) and collagen membrane to be used for bone augmentation around exposed threads of inserted dental implants.
    Arm Title
    MPM Augmentation.
    Arm Type
    Active Comparator
    Arm Description
    Mineralized plasmatic matrix (MPM) to be used without collagen membrane to augment the defect in the maxillary bone and cover the exposed threads of the dental implants.
    Intervention Type
    Other
    Intervention Name(s)
    Mineralized plasmatic matrix (MPM).
    Other Intervention Name(s)
    Sticky bone graft.
    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, for 10 minutes , Which will result if sticky bone graft consistency after mixing.
    Intervention Type
    Other
    Intervention Name(s)
    Autogenous bone graft (gold standard).
    Other Intervention Name(s)
    Autobone.
    Intervention Description
    Exposed implant threads are to be covered with autogenous bone and collagen membrane.
    Primary Outcome Measure Information:
    Title
    Patient Satisfaction regarding esthetic results , outcome will be measure using questionnaire.
    Time Frame
    5 months
    Secondary Outcome Measure Information:
    Title
    Stability of dental implants , this will be measured using Ostell device in ISQ units.
    Time Frame
    5 months.

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    40 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Medically free patients. Evaluated bone height on CBCT to be (0-4 mm buccal bone dehiscence) and width (not less than 4.5 mm) Patients with Anterior maxillary defective partially edentulous ridge. Age between 18 and 40 years. Both sexes. Patients physically able to tolerate surgical and restorative procedures. Patients with an opposing tooth to the pre-implant site. Good oral hygiene. Highly motivated patients. Exclusion Criteria: Patients allergic to local anesthetic agent. Pregnant or lactating females. Presence of any pathosis in the pre-implant site. Presence of any mucosal disease. Presence of parafunctional habits. History of oral radiotherapy. History of prolonged steroids use. Psychological disorders.

    12. IPD Sharing Statement

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

    Learn more about this trial

    Preimplant Site Augmentation Using MPM Versus Autogenous Bone Graft

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