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
About this trial
This is an interventional treatment trial for Bone Resorption
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.
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
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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