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

Primary Purpose

Fibrin/Therapeutic Use, Blood Platelets, Molar, Third

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Platelet-rich fibrin
Control group
Sponsored by
Rio de Janeiro State University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibrin/Therapeutic Use focused on measuring platelet-rich fibrin, third molar, bone regeneration

Eligibility Criteria

16 Years - 29 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • João Canellas

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Platelet-rich fibrin group

Control group

Arm Description

Use platelet-rich fibrin after mandibular third molar extraction

mandibular third molar extraction

Outcomes

Primary Outcome Measures

Change in bone density through tomography evaluation

Secondary Outcome Measures

Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation
Pain through Visual Analogue Scale
Pain through Visual Analogue Scale
Pain through Visual Analogue Scale
Soft tissue healing through Clinical evaluation numeric scale

Full Information

First Posted
August 24, 2016
Last Updated
April 10, 2017
Sponsor
Rio de Janeiro State University
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1. Study Identification

Unique Protocol Identification Number
NCT02890680
Brief Title
Effects of the Use of Platelet-rich Fibrin on Bone Regeneration After Impacted Third Molar Surgery
Official Title
Randomized Double Blind Clinical Trial Evaluation of Bone Regeneration After Impacted Third Molar Surgery With the of Platelet-rich Fibrin: Pilot Study
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
August 2016 (undefined)
Primary Completion Date
November 2016 (Actual)
Study Completion Date
January 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rio de Janeiro State University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibrin/Therapeutic Use, Blood Platelets, Molar, Third, Bone Regeneration
Keywords
platelet-rich fibrin, third molar, bone regeneration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet-rich fibrin group
Arm Type
Experimental
Arm Description
Use platelet-rich fibrin after mandibular third molar extraction
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
mandibular third molar extraction
Intervention Type
Procedure
Intervention Name(s)
Platelet-rich fibrin
Intervention Type
Procedure
Intervention Name(s)
Control group
Primary Outcome Measure Information:
Title
Change in bone density through tomography evaluation
Time Frame
Change from Baseline bone measurement at three months after surgery
Secondary Outcome Measure Information:
Title
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
Title
Pain through Visual Analogue Scale
Time Frame
1st day after surgery
Title
Pain through Visual Analogue Scale
Time Frame
3rd day after surgery
Title
Pain through Visual Analogue Scale
Time Frame
7th day after surgery
Title
Soft tissue healing through Clinical evaluation numeric scale
Time Frame
7th day after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
29 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
João Vitor Canellas, DDS; MSc
Organizational Affiliation
Rio de Janeiro University State
Official's Role
Principal Investigator
Facility Information:
Facility Name
João Canellas
City
Rio de Janeiro
ZIP/Postal Code
24240170
Country
Brazil

12. IPD Sharing Statement

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

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