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

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ClinicalTrials.gov Identifier: NCT03014388
Recruitment Status : Unknown
Verified December 2016 by Refaat Ragab Abu Ellill, Cairo University.
Recruitment status was:  Not yet recruiting
First Posted : January 9, 2017
Last Update Posted : January 9, 2017
Sponsor:
Information provided by (Responsible Party):
Refaat Ragab Abu Ellill, Cairo University

Study Description
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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.

Condition or disease Intervention/treatment Phase
Bone Resorption Other: autogenous bone Other: Mineralized plasmatic matrix Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
Study Start Date : January 2017
Estimated Primary Completion Date : September 2017
Estimated Study Completion Date : October 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

Arms and Interventions
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Arm Intervention/treatment
Experimental: Autogenous bone graft (Gold Standard).
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.
 Other: autogenous bone
Autogenous bone graft (gold standard). sinus lift with autogenous bone.
Other Name: Autobone
Experimental: Mineralized Plasmatic Matrix (MPM)
Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.
 Other: Mineralized plasmatic matrix
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.
Other Name: MPM


Outcome Measures
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Primary Outcome Measures :
  1. Patient Satisfaction regarding aesthetic results will be measured using questionnaire. [ Time Frame: 9 months ]
    outcome will be measure using questionnaire.


Secondary Outcome Measures :
  1. Stability of dental implants. [ Time Frame: 5 months ]
    will be measured using OSTELL Device.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03014388


Contacts
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Contact: refaat ragab, Master 01111175536 refaat.ragab.rr@gmail.com

Sponsors and Collaborators
Cairo University
Investigators
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Principal Investigator: Cairo University CBE Cairo University - Ethics Committee.
More Information
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Responsible Party: Refaat Ragab Abu Ellill, Dentist at menistry of health, Cairo University
ClinicalTrials.gov Identifier: NCT03014388    
Other Study ID Numbers: CairoU MPM
First Posted: January 9, 2017    Key Record Dates
Last Update Posted: January 9, 2017
Last Verified: December 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.
Additional relevant MeSH terms:
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Bone Resorption
Bone Diseases
Musculoskeletal Diseases