The Use of PRF in the Management of Soft Tissue Healing (PRF)

December 24, 2019 updated by: Vittorio Moraschini Filho, Universidade Federal Fluminense

The Use of Platelet-rich Fibrin in the Management of Soft Tissue Healing and Pain in Post-extraction Sockets: a Randomized Clinical Trial

The present study aimed to evaluate the clinical effect of platelet-rich fibrin to improve epithelialization and decrease postoperative pain in post extraction sockets

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Production of PRF membranes A venipuncture was performed, prior of performing any treatment (median basilica vein, median cubital vein, median cephalic vein). Blood was drawn into four sterile, red cover tubes (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA) 10-mL tubes without anticoagulant. The tubes were immediately centrifuged at 2700 rpm for 12 min (~708g) using a vertical/ fixed angle centrifuge (IntraSpin™, Biohorizons®, Birmingham, Alabama, USA). The g-force values were referenced at the bottom of the centrifugation tubes (RCF-max). After centrifugation, each L-PRF clot was removed from the tube and separated from the red element phase at the base with pliers. Four L-PRF clots were squeezed between a sterile metal plate and a metal box to obtain L-PRF membranes, similar in size and thickness.

Surgical procedures and initial clinical measurements The participants underwent periapical radiography or computed tomography (when necessary) and clinical examination to assess the absolute need for dental extraction. The participants underwent initial periodontal treatment, including supra and subgingival scaling, plaque control, and were given oral hygiene instructions.

Before tooth extraction, participants from both groups underwent local anaesthesia with mepivacaine 2% (Mepiadre, Nova DFL, Rio de Janeiro, Brazil). All teeth were extracted using a minimally traumatic procedure. No vertical releasing incisions were performed. To avoid root and bony fractures, the molar teeth were sectioned using a multilaminated drill (Zecrya, Microdont, São Paulo, Brazil). Luxation of the teeth was performed using a periotome followed by removal using forceps. After exodontia, a rigorous inspection and curettage of the socket was performed, followed by irrigation with sterile saline solution (Linhamax, Eurofarma, Rio de Janeiro, Brazil).

The sockets of the test group were filled with two PRF membranes followed by cross suture (Mononylon Ethilon, Johnson & Johnson, NJ, USA) to stabilize the membranes (Figure 1A), while the sockets of the control group received no type of biomaterial (i.e., left to spontaneous healing).

Postoperative control It was prescribed Ibuprofen (400 mg, Advil, Pfizer, São Paulo, Brazil) every 6 h was also prescribed in case of pain. Mouthwash with chlorhexidine gluconate 0.12% (Periogard, Colgate, São Paulo, Brazil) was also prescribed twice per day for 2 weeks. Sutures were removed after 10 days.

Clinical measurements One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al (Landry, 1985). The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.

Postoperative pain and number of consumed analgesic tablets were recorded and evaluated. To assess postoperative pain, participants were instructed to complete a 10-unit visual analog scale (VAS) in combination with a graphic rating scale. The VAS ranged from 0 (no pain) to 100 (worst pain imaginable). Questionnaires were collected at the one week follow-up visit.

Study Type

Interventional

Enrollment (Actual)

32

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

  • Brazil
    • Rio De Janeiro
      • Niterói, Rio De Janeiro, Brazil, 24020-140
        • Dental Clinical Research Center of the Fluminense Federal University

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants ≥ 18 years of age;
  • Participants needing molar extraction in the mandible or maxilla region.

Exclusion Criteria:

  • Smokers;
  • Pregnant;
  • Participants with motor difficulties that impeded or hampered hygien;
  • Participants with decompensated metabolic diseases;
  • Participants with periodontal disease;
  • Participants with history of radiotherapy or use of bisphosphonates.

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: Test group
Post-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16)
Procedure: Alveolar socket preservation with Platelet-rich fibrin
The sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture
Other Names:
  • Platelet-Rich Fibrin
No Intervention: Control Goroup
Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluation of the soft tissue epithelialization speed in post-extraction sockets
Time Frame: 90 days
One and two weeks after extraction, an assessment of soft tissue healing around the sockets was performed using the healing index system described by Landry et al. The following parameters were used to assess the level of healing: colour of tissues; epithelialisation of wound margins; presence of bleeding on palpation; granulation; and suppuration. The level of healing was scored as very poor, poor, good, very good, or excellent.
90 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Postoperative pain
Time Frame: 90 days
The participants were instructed to complete a 10-unit visual analog scale (VAS) in combination with a graphic rating scale. The VAS ranged from 0 (no pain) to 100 (worst pain imaginable).
90 days
Number of consumed analgesic
Time Frame: 90 days
Questionnaires were collected at the one week follow-up visit.
90 days

Collaborators and Investigators

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

Sponsor

Universidade Federal Fluminense

Investigators

  • Principal Investigator: Vittorio Moraschini, PhD, Fluminense Federal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

April 15, 2017

Primary Completion (Actual)

August 15, 2019

Study Completion (Actual)

November 15, 2019

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

December 24, 2019

First Posted (Actual)

December 30, 2019

Study Record Updates

Last Update Posted (Actual)

December 30, 2019

Last Update Submitted That Met QC Criteria

December 24, 2019

Last Verified

December 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PRF1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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