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

Bone Regeneration Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02890680
• Other study ID #: CAAE 56621216.5.0000.5259
• Status: Completed
• Phase: N/A
• First received: August 24, 2016
• Last updated: April 10, 2017
• Start date: August 2016
• Est. completion date: January 2017

Study information

• Verified date: April 2017
• Source: Rio de Janeiro State University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: January 2017
• Est. primary completion date: November 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 16 Years to 29 Years

Eligibility

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

Related Conditions & MeSH terms

• Blood Platelets
• Bone Regeneration
• Fibrin/Therapeutic Use
• Molar, Third

Intervention

Procedure:
• Platelet-rich fibrin

• Control group

Locations

Country	Name	City	State
Brazil	João Canellas	Rio de Janeiro

Sponsors (1)

Lead Sponsor	Collaborator
Rio de Janeiro State University

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in bone density through tomography evaluation		Change from Baseline bone measurement at three months after surgery
Secondary	Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation		Change from baseline at 3 months after surgery
Secondary	Pain through Visual Analogue Scale		1st day after surgery
Secondary	Pain through Visual Analogue Scale		3rd day after surgery
Secondary	Pain through Visual Analogue Scale		7th day after surgery
Secondary	Soft tissue healing through Clinical evaluation numeric scale		7th day after surgery