Implant Placement in Mandibular Molar Xenograft Versus PRF
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.
1 other identifier
interventional
20
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jul 2016
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 3, 2017
CompletedFirst Posted
Study publicly available on registry
June 6, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 6, 2017
June 1, 2017
1 year
June 3, 2017
June 5, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Patient satisfaction
evaluation of postoperative complications regarding pain and oedema
1 week post operative
Secondary Outcomes (2)
implant stability
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
amount of bone gained or lost around the implants
6 months postoperative
Study Arms (2)
extraction,implant placement,PRF
EXPERIMENTALExtraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material
Exctraction,Implant placement,Bone graft
ACTIVE COMPARATORExtraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material
Interventions
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 Then a blood sample is withdrawn from patient and placed in the centrifuge.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
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
Eligibility Criteria
You may qualify if:
- Patients with non-restorable mandibular molars
- Both sexes
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- DR.
Study Record Dates
First Submitted
June 3, 2017
First Posted
June 6, 2017
Study Start
July 1, 2016
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
June 6, 2017
Record last verified: 2017-06