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Implant Placement in Mandibular Molar Xenograft Versus PRF

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ClinicalTrials.gov Identifier: NCT03177356
Recruitment Status : Active, not recruiting
First Posted : June 6, 2017
Last Update Posted : June 6, 2017
Sponsor:
Information provided by (Responsible Party):
Ahmed Hussein El Garhy, Cairo University

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.

Condition or disease Intervention/treatment Phase
Edentulous Alveolar Ridge Procedure: extraction,implant placement,PRF Procedure: Exctraction,Implant placement,Bone graft Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
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.
Actual Study Start Date : July 2016
Estimated Primary Completion Date : July 2017
Estimated Study Completion Date : July 2017

Arm Intervention/treatment
Experimental: extraction,implant placement,PRF
Extraction of Mandibular first molar and Implant placement followed by Placement of placement of Platelet rich fibrin as space filling material
Procedure: extraction,implant placement,PRF
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 Then a blood sample is withdrawn from patient and placed in the centrifuge.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

Active Comparator: Exctraction,Implant placement,Bone graft
Extraction of mandibular first molar followed by implant placement and xenogenic bone graft as space filling material
Procedure: Exctraction,Implant placement,Bone graft
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 Measures :
  1. Patient satisfaction [ Time Frame: 1 week post operative ]
    evaluation of postoperative complications regarding pain and oedema


Secondary Outcome Measures :
  1. implant stability [ 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 ]
    measurement of implant stability using osstell device

  2. amount of bone gained or lost around the implants [ Time Frame: 6 months postoperative ]
    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



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Patients with non-restorable mandibular molars
  2. 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.

Responsible Party: Ahmed Hussein El Garhy, DR., Cairo University
ClinicalTrials.gov Identifier: NCT03177356     History of Changes
Other Study ID Numbers: cebc.cairouniversity
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: June 6, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Ahmed Hussein El Garhy, Cairo University:
Platelet rich fibrin,xenograft