Back to resultsImplant Placement in Mandibular Molar Xenograft Versus PRF
Primary Purpose
Edentulous Alveolar Ridge
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
extraction,implant placement,PRF
Exctraction,Implant placement,Bone graft
Sponsored by
About this trial
This is an interventional treatment trial for Edentulous Alveolar Ridge focused on measuring Platelet rich fibrin,xenograft
Eligibility Criteria
Inclusion Criteria:
- Patients with non-restorable mandibular molars
Both sexes
-
Exclusion Criteria:
• Heavy smokers more than 20 cigarettes per day.5
Patients with in sufficient interseptal bone height and width
- Patients with systemic disease that may affect normal healing.
- Patients with completely resorbed buccal cortical plate.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
extraction,implant placement,PRF
Exctraction,Implant placement,Bone graft
Arm Description
Extraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material
Extraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material
Outcomes
Primary Outcome Measures
Patient satisfaction
evaluation of postoperative complications regarding pain and oedema
Secondary Outcome Measures
implant stability
measurement of implant stability using osstell device
amount of bone gained or lost around the implants
two cone beam computed tomography (CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03177356
Brief Title
Implant Placement in Mandibular Molar Xenograft Versus PRF
Official Title
Immediate Implant Placement With Deproteinized Bovine Bone (Tutogen) Versus Placement of Platelet-rich Fibrin as a Space Filling Material in Mandibular Molars. Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
June 2017
Overall Recruitment Status
Unknown status
Study Start Date
July 2016 (Actual)
Primary Completion Date
July 2017 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
20 recruited patients indicated for immediate implant placement in mandibular molar patients are divided into 2 groups each group contain 15 patients, one group assigned for placement of bovine bone after molar extraction and immediate implant placement, while the other group we use Platelet-rich fibrin as space filling material.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Edentulous Alveolar Ridge
Keywords
Platelet rich fibrin,xenograft
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
extraction,implant placement,PRF
Arm Type
Experimental
Arm Description
Extraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material
Arm Title
Exctraction,Implant placement,Bone graft
Arm Type
Active Comparator
Arm Description
Extraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material
Intervention Type
Procedure
Intervention Name(s)
extraction,implant placement,PRF
Intervention Description
Surgical extraction of mandibular molar using periotome and forceps followed by implant placement in inter-septal bone. Then a blood sample is withdrawn from patient and placed in the centrifuge. Then Platelet-Rich fibrin is placed in the extraction socket as space filling material
Intervention Type
Procedure
Intervention Name(s)
Exctraction,Implant placement,Bone graft
Intervention Description
Surgical extraction of mandibular molar using extraction forceps and periotome followed by implant placement in interseptal bone. De-proteinized bovine bone graft material is placed as space filling material
Primary Outcome Measure Information:
Title
Patient satisfaction
Description
evaluation of postoperative complications regarding pain and oedema
Time Frame
1 week post operative
Secondary Outcome Measure Information:
Title
implant stability
Description
measurement of implant stability using osstell device
Time Frame
will be measure intraopertively immediately after insertion of the implants and will be measure one more time 6 months after 1st operation at the time of exposure of implants
Title
amount of bone gained or lost around the implants
Description
two cone beam computed tomography (CBCT) will be taken for the patient, one immediate postoperative and the other 6 months after the operation then the height of bone gained or lost around the implants will be assessed by superimposing the same section in the two CBCTS
Time Frame
6 months postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with non-restorable mandibular molars
Both sexes
-
Exclusion Criteria:
• Heavy smokers more than 20 cigarettes per day.5
Patients with in sufficient interseptal bone height and width
Patients with systemic disease that may affect normal healing.
Patients with completely resorbed buccal cortical plate.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Learn more about this trial
Implant Placement in Mandibular Molar Xenograft Versus PRF
We'll reach out to this number within 24 hrs