NCT02890680

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2016

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2016

Completed
23 days until next milestone

First Submitted

Initial submission to the registry

August 24, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

September 7, 2016

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

April 12, 2017

Status Verified

April 1, 2017

Enrollment Period

3 months

First QC Date

August 24, 2016

Last Update Submit

April 10, 2017

Conditions

Fibrin/Therapeutic UseBlood PlateletsMolar, ThirdBone Regeneration

Keywords

platelet-rich fibrinthird molarbone regeneration

Outcome Measures

Primary Outcomes (1)

  • Change in bone density through tomography evaluation

    Change from Baseline bone measurement at three months after surgery

Secondary Outcomes (5)

  • 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

    1st day after surgery

  • Pain through Visual Analogue Scale

    3rd day after surgery

  • Pain through Visual Analogue Scale

    7th day after surgery

  • Soft tissue healing through Clinical evaluation numeric scale

    7th day after surgery

Study Arms (2)

Platelet-rich fibrin group

EXPERIMENTAL

Use platelet-rich fibrin after mandibular third molar extraction

Procedure: Platelet-rich fibrin

Control group

PLACEBO COMPARATOR

mandibular third molar extraction

Procedure: Control group

Interventions

Platelet-rich fibrinPROCEDURE
Platelet-rich fibrin group
Control groupPROCEDURE
Control group

Eligibility Criteria

Age16 Years - 29 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Healthy patients
  • Preoperative platelet count higher than 150,00/ mm3
  • Patient who required bilateral mandibular third molar extractions

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

João Canellas

Rio de Janeiro, Rio de Janeiro, 24240170, Brazil

Location

MeSH Terms

Interventions

Control Groups

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • João Vitor Canellas, DDS; MSc

    Rio de Janeiro University State

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MSc

Study Record Dates

First Submitted

August 24, 2016

First Posted

September 7, 2016

Study Start

August 1, 2016

Primary Completion

November 1, 2016

Study Completion

January 1, 2017

Last Updated

April 12, 2017

Record last verified: 2017-04

Locations

BR(1)