Use of PRF in Treatment of Dry Socket.

April 23, 2021 updated by: Medical University of Lodz

Evaluation of Platelet Rich Fibrin Use in the Treatment of Dry Socket.

The aim of the study is to evaluate the influence of PRF application in case of alveolar osteitis.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The main objective was to compare the effects of using two different methods in the treatment of dry socket (alveolar osteitis), which is a postoperative complication of dental extraction. The first was Nipas, applied, if dry socket was diagnosed following a tooth extraction. In case of subsequent extraction of homonymous tooth and reoccurrence of dry socket, patients were treated with application of PRF.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Poland
      • Lodz, Poland, 92-213
        • Department of Oral Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • no known medical history of abnormal platelet counts,
  • patients with symmetric teeth qualified for extraction,

Exclusion Criteria:

  • patients treated previously for existing dry socket,
  • patients allergic to acetylsalicylic acid ,
  • systemic diseases,
  • pregnancy,
  • lactation,
  • drugs known to affect the number or function of platelets,
  • abnormal platelet counts,

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PRF application
Patients with alveolar osteitis in which PRF application was performed.
Procedure: PRF application
PRF application into post-operative wound.
Active Comparator: Aspirin application
Patients with alveolar osteitis in which Nipas was used.
Drug: Nipas application
Nipas application into post-operative wound.
Other Names:
  • Aspirin paste

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensity of pain vs. PRF and Nipas application
Time Frame: 24 hours

In order to evaluate the relationship between intensity of pain after application of PRF and Nipas, Numeric Rating Scale pain scale is used. NRS is a horizontal line with an eleven point numeric range. It is labeled from zero to ten, with zero being an example of someone with no pain and ten being the worst pain possible.

The higher score means worse outcome in case of present study.
24 hours
Influence of treatment on bacteria levels in wounds
Time Frame: 24 hours
The second part of the study was dedicated to analyzing the number of bacteria in tooth extraction wounds.
24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical University of Lodz

Investigators

  • Principal Investigator: Anna Janas-Naze, Prof., Medical University of Lodz

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2019

Primary Completion (Anticipated)

July 1, 2021

Study Completion (Anticipated)

July 1, 2021

Study Registration Dates

First Submitted

July 15, 2020

First Submitted That Met QC Criteria

July 15, 2020

First Posted (Actual)

July 17, 2020

Study Record Updates

Last Update Posted (Actual)

April 26, 2021

Last Update Submitted That Met QC Criteria

April 23, 2021

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0002

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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