NCT01583491

Brief Summary

The purpose of this study is to determine the influence of platelet rich fibrin to reduction of periodontal problems after surgical removal of third molar.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Dec 2011

Shorter than P25 for phase_4

Status
unknown

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

December 1, 2011

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

December 7, 2011

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2012

Completed
23 days until next milestone

First Posted

Study publicly available on registry

April 24, 2012

Completed
7 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2012

Completed
Last Updated

April 25, 2012

Status Verified

April 1, 2012

Enrollment Period

4 months

First QC Date

December 7, 2011

Last Update Submit

April 24, 2012

Conditions

Mastication Disorder

Keywords

platelet rich fibrinmandibular third molarperiodontal problem

Outcome Measures

Primary Outcomes (1)

  • Measurement of periodontal pocket depth at mid buccal, disto buccal and distolingual of mandibular second molar

    4 months

Study Arms (2)

prf group.peridontal problem

ACTIVE COMPARATOR

prf insert into surgical site immediate after surgery

Procedure: autologous platlet rich fibrin

control group

PLACEBO COMPARATOR
Procedure: one side in control group

Interventions

autologous platlet rich fibrinPROCEDURE

one dose immediate after surgery

Also known as: prf
prf group.peridontal problem
one side in control groupPROCEDURE

control group insert any things after surgery

control group

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • have 2 impacted third molars

You may not qualify if:

  • periodontal disease
  • history of periodontal surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Prolactin-Releasing HormoneControl Groups

Intervention Hierarchy (Ancestors)

Hypothalamic HormonesPeptide HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsNeuropeptidesPeptidesAmino Acids, Peptides, and ProteinsNerve Tissue ProteinsProteinsEpidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

December 7, 2011

First Posted

April 24, 2012

Study Start

December 1, 2011

Primary Completion

April 1, 2012

Study Completion

May 1, 2012

Last Updated

April 25, 2012

Record last verified: 2012-04