Implant Placement in Mandibular Molar Xenograft Versus PRF

June 5, 2017 updated by: Ahmed Hussein El Garhy, Cairo University

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.

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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 Then a blood sample is withdrawn from patient and placed in the centrifuge.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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient satisfaction
Time Frame: 1 week post operative
evaluation of postoperative complications regarding pain and oedema
1 week post operative

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
6 months postoperative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 1, 2016

Primary Completion (ANTICIPATED)

July 1, 2017

Study Completion (ANTICIPATED)

July 1, 2017

Study Registration Dates

First Submitted

June 3, 2017

First Submitted That Met QC Criteria

June 5, 2017

First Posted (ACTUAL)

June 6, 2017

Study Record Updates

Last Update Posted (ACTUAL)

June 6, 2017

Last Update Submitted That Met QC Criteria

June 5, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • cebc.cairouniversity

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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