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NCT03177356 Clinical Trial

Implant Placement in Mandibular Molar Xenograft Versus PRF

Edentulous Alveolar Ridge Clinical Trial

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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT03177356
Other study ID # cebc.cairouniversity
Secondary ID
Status Active, not recruiting
Phase N/A
First received June 3, 2017
Last updated June 5, 2017
Start date July 2016
Est. completion date July 2017

Study information
Verified date June 2017
Source Cairo University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 20
Est. completion date July 2017
Est. primary completion date July 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

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 Then a blood sample is withdrawn from patient and placed in the centrifuge.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
• 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

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Cairo University

Outcome
Type Measure Description Time frame Safety issue
Primary Patient satisfaction evaluation of postoperative complications regarding pain and oedema 1 week post operative
Secondary implant stability measurement of implant stability using osstell device 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
Secondary 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 6 months postoperative
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