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NCT02890680 Clinical Trial

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
Secondary ID
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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