Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Tracking Information
First Submitted Date  ICMJE January 5, 2017
First Posted Date  ICMJE January 9, 2017
Last Update Posted Date January 9, 2017
Study Start Date  ICMJE January 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Patient Satisfaction regarding aesthetic results will be measured using questionnaire. [ Time Frame: 9 months ]
outcome will be measure using questionnaire.
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: January 5, 2017)
Stability of dental implants. [ Time Frame: 5 months ]
will be measured using OSTELL Device.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft
Official Title  ICMJE Posterior Maxillary Ridge Augmentation With Sinus Lift Using Mineralized Plasmatic Matrix Versus Autogenous Bone Graft (A Randomized Clinical Trial Comparative Study)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Bone Resorption
Intervention  ICMJE
  • Other: autogenous bone
    Autogenous bone graft (gold standard). sinus lift with autogenous bone.
    Other Name: Autobone
  • 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
Study Arms  ICMJE
  • 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.
    Intervention: Other: autogenous bone
  • Experimental: Mineralized Plasmatic Matrix (MPM)
    Patients with defective posterior maxillary alveolar ridges requiring implant insertion will receive bone graft using Mineralized plasmatic matrix.
    Intervention: Other: Mineralized plasmatic matrix
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: January 5, 2017)
20
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2017
Estimated Primary Completion Date September 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 50 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03014388
Other Study ID Numbers  ICMJE CairoU MPM
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Plan Description: Evaluation of the comparative Effectiveness of MPM Augmentation in posterior maxillary ridge defects with Autogenous bone graft.
Responsible Party Refaat Ragab Abu Ellill, Cairo University
Study Sponsor  ICMJE Cairo University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Cairo University CBE Cairo University - Ethics Committee.
PRS Account Cairo University
Verification Date December 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP