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Clinical Trials/NCT02890680
NCT02890680CompletedNot Applicable

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

Rio de Janeiro State University2 sites in 1 country20 target enrollmentStarted: August 1, 2016Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
20
Locations
2
Primary Endpoint
Change in bone density through tomography evaluation

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
16 Years to 29 Years (Child, Adult)
Sex
All
Accepts Healthy Volunteers
Yes

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

Outcomes

Primary Outcomes

Change in bone density through tomography evaluation

Time Frame: Change from Baseline bone measurement at three months after surgery

Secondary Outcomes

  • Change in periodontal-probing depth measurement on distal aspect of the second molar through Clinical evaluation(Change from baseline at 3 months after surgery)
  • Pain through Visual Analogue Scale(7th day after surgery)
  • Soft tissue healing through Clinical evaluation numeric scale(7th day after surgery)

Investigators

Sponsor
Rio de Janeiro State University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

João Vitor dos Santos Canellas, DDS MS

MSc

Rio de Janeiro State University

Study Sites (2)

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