Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery

April 10, 2017 updated by: João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University

Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study

The purpose of this study is to evaluate the bone regeneration after impacted third molar surgery on split mouth design using platelet-rich fibrin.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Rio de Janeiro, Brazil, 24240170
        • João Canellas

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

16 years to 29 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Healthy patients
  • Preoperative platelet count higher than 150,00/ mm3
  • Patient who required bilateral mandibular third molar extractions

Exclusion Criteria:

  • Smokers patients
  • Alcoholics patients
  • Patients whom the inferior second molar was missing
  • Patients who had acute pericoronitis on the inferior third molar
  • Severe periodontal disease

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 Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Platelet-rich fibrin group
Use platelet-rich fibrin after mandibular third molar extraction
Procedure: Platelet-rich fibrin
Placebo Comparator: Control group
mandibular third molar extraction
Procedure: Control group

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in bone density through tomography evaluation
Time Frame: Change from Baseline bone measurement at three months after surgery
Change from Baseline bone measurement at three months after surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation
Time Frame: Change from baseline at 3 months after surgery
Change from baseline at 3 months after surgery
Pain through Visual Analogue Scale
Time Frame: 1st day after surgery
1st day after surgery
Pain through Visual Analogue Scale
Time Frame: 3rd day after surgery
3rd day after surgery
Pain through Visual Analogue Scale
Time Frame: 7th day after surgery
7th day after surgery
Soft tissue healing through Clinical evaluation numeric scale
Time Frame: 7th day after surgery
7th day after surgery

Collaborators and Investigators

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

Sponsor

Rio de Janeiro State University

Investigators

  • Principal Investigator: João Vitor Canellas, DDS; MSc, Rio de Janeiro University State

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

August 1, 2016

Primary Completion (Actual)

November 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

August 24, 2016

First Submitted That Met QC Criteria

August 31, 2016

First Posted (Estimate)

September 7, 2016

Study Record Updates

Last Update Posted (Actual)

April 12, 2017

Last Update Submitted That Met QC Criteria

April 10, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CAAE 56621216.5.0000.5259

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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