Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Clinical, Histological and Micro-computed Tomographic Evaluation of Neoformed Tissue in Post-extraction Sockets Covered With Platelet-rich Fibrin (PRF) Membrane: a Randomized Controlled Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02300246
Recruitment Status : Unknown
Verified November 2014 by Vittorio Moraschini Filho, Universidade Federal Fluminense.
Recruitment status was:  Recruiting
First Posted : November 24, 2014
Last Update Posted : November 24, 2014
Sponsor:
Collaborators:
Eliane dos Santos Porto Barboza
Diogo Luz
Denise Mandarino
Information provided by (Responsible Party):
Vittorio Moraschini Filho, Universidade Federal Fluminense

Brief Summary:
The platelet-rich fibrin (PRF), belongs to a new generation of plasma concentrate with biomechanical processing simplified and without the need for handling blood biochemistry. Some studies have shown the potential of PRF in release growth factors assisting and accelerating the regeneration of soft tissues, however with contradictory results regarding the hard tissues. The aim of this study will be to evaluate through clinical analyzes, histomorphometric and micro-computed tomographic images, the dimensional changes, the quantity and the quality of the tissues formed socket after extractions that receive membranes of PRF. 15 sockets (test group) will receive a membrane of PRF after extraction and the other 15 (control group) received no biomaterial (spontaneous healing).

Condition or disease Intervention/treatment Phase
Alveolar Socket Preservation Procedure: Platelet-Rich Fibrin Phase 1

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Clinical, Histological and Micro-computed Tomographic Evaluation of Neoformed Tissue in Post-extraction Sockets Covered With Platelet-rich Fibrin (PRF) Membrane: a Randomized Controlled Trial
Study Start Date : July 2014
Estimated Primary Completion Date : December 2014

Arm Intervention/treatment
Experimental: Test Group
Alveolar socket post-extraction covered with PRF
Procedure: Platelet-Rich Fibrin
Alveolar socket preservation with Platelet-Rich Plasma

No Intervention: Control Group
Only clot (spontaneous healing)



Primary Outcome Measures :
  1. Dimensional changes of the alveolar crest. [ Time Frame: 120 days ]
    Clinical examination, histological and micro-computed tomography analyses will be conducted.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients aged over 18 years
  • Healthy patients with indication for dental extraction
  • Teeth adjacent to the extraction site
  • Patients willing to cooperate with the study and who have signed the informed consent form.

Exclusion Criteria:

  • Patients showing periapical or periodontal infection
  • Patients with severe systemic diseases
  • Patients on medications such as chemotherapy, anticoagulants, corticosteroids, biphosphonates and drugs imunossupressivas
  • Patients who have chronic diseases decompensated (e.g. hypertension, diabetes, rheumatic diseases, renal, and hepatic)
  • Patients with bone diseases, metabolic (osteomalacia, hypocalcemia and hypercalcemia).

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02300246


Contacts
Layout table for location contacts
Contact: Vittorio Moraschini, PhD 55(21)996626930 vittoriomf@terra.com.br
Contact: Eliane Barboza, PhD 55(21)979808811 elianeporto.uff@gmail.com

Locations
Layout table for location information
Brazil
Vittorio Moraschini Recruiting
Niteroi, Rio de Janeiro, Brazil, 24230126
Sponsors and Collaborators
Universidade Federal Fluminense
Eliane dos Santos Porto Barboza
Diogo Luz
Denise Mandarino