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

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: NCT02890680
Recruitment Status : Completed
First Posted : September 7, 2016
Last Update Posted : April 12, 2017
Sponsor:
Information provided by (Responsible Party):
João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University

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.

Condition or disease Intervention/treatment Phase
Fibrin/Therapeutic Use Blood Platelets Molar, Third Bone Regeneration Procedure: Platelet-rich fibrin Procedure: Control group Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : August 2016
Actual Primary Completion Date : November 2016
Actual Study Completion Date : January 2017

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



Primary Outcome Measures :
  1. Change in bone density through tomography evaluation [ Time Frame: Change from Baseline bone measurement at three months after surgery ]

Secondary Outcome Measures :
  1. 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 ]
  2. Pain through Visual Analogue Scale [ Time Frame: 1st day after surgery ]
  3. Pain through Visual Analogue Scale [ Time Frame: 3rd day after surgery ]
  4. Pain through Visual Analogue Scale [ Time Frame: 7th day after surgery ]
  5. Soft tissue healing through Clinical evaluation numeric scale [ Time Frame: 7th day after surgery ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 29 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

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): NCT02890680


Locations
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Brazil
João Canellas
Rio de Janeiro, Brazil, 24240170
Sponsors and Collaborators
Rio de Janeiro State University
Investigators
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Principal Investigator: João Vitor Canellas, DDS; MSc Rio de Janeiro University State
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Responsible Party: João Vitor dos Santos Canellas, DDS MS, MSc, Rio de Janeiro State University
ClinicalTrials.gov Identifier: NCT02890680    
Other Study ID Numbers: CAAE 56621216.5.0000.5259
First Posted: September 7, 2016    Key Record Dates
Last Update Posted: April 12, 2017
Last Verified: April 2017
Keywords provided by João Vitor dos Santos Canellas, DDS MS, Rio de Janeiro State University:
platelet-rich fibrin
third molar
bone regeneration
Additional relevant MeSH terms:
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Tooth, Impacted
Tooth Diseases
Stomatognathic Diseases