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
About this trial
This is an interventional treatment trial for Bone Resorption
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.
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
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
We'll reach out to this number within 24 hrs