The Use of PRF in the Management of Soft Tissue Healing

NCT04212767 | Completed

• 1 other identifier: PRF1
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dental Diseases

Keywords

Tooth extraction; Platelet-rich fibrin; Soft tissue

Outcome Measures

Primary Outcomes (1)

• Evaluation of the soft tissue epithelialization speed in post-extraction sockets

  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 Outcomes (2)

• Postoperative pain

  90 days

• Number of consumed analgesic

  90 days

Study Arms (2)

Test group

EXPERIMENTAL

Post-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16)

Procedure: Alveolar socket preservation with Platelet-rich fibrin

Control Goroup

NO INTERVENTION

Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16).

Interventions

Alveolar socket preservation with Platelet-rich fibrin PROCEDURE

The sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture

Also known as: Platelet-Rich Fibrin

Test group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Universidade Federal Fluminense: lead

Study Sites (1)

Dental Clinical Research Center of the Fluminense Federal University

Niterói, Rio de Janeiro, 24020-140, Brazil

Location

Related Publications (3)

• Lei L, Yu Y, Han J, Shi D, Sun W, Zhang D, Chen L. Quantification of growth factors in advanced platelet-rich fibrin and concentrated growth factors and their clinical efficacy as adjunctive to the GTR procedure in periodontal intrabony defects. J Periodontol. 2020 Apr;91(4):462-472. doi: 10.1002/JPER.19-0290. Epub 2019 Nov 17.

  PMID: 31471902 BACKGROUND

• Castro AB, Cortellini S, Temmerman A, Li X, Pinto N, Teughels W, Quirynen M. Characterization of the Leukocyte- and Platelet-Rich Fibrin Block: Release of Growth Factors, Cellular Content, and Structure. Int J Oral Maxillofac Implants. 2019 July/August;34(4):855-864. doi: 10.11607/jomi.7275. Epub 2019 Feb 11.

  PMID: 30742137 BACKGROUND

• Dohan DM, Choukroun J, Diss A, Dohan SL, Dohan AJ, Mouhyi J, Gogly B. Platelet-rich fibrin (PRF): a second-generation platelet concentrate. Part II: platelet-related biologic features. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2006 Mar;101(3):e45-50. doi: 10.1016/j.tripleo.2005.07.009. Epub 2006 Jan 10.

  PMID: 16504850 RESULT

MeSH Terms

Conditions

Stomatognathic Diseases

Study Officials

• Vittorio Moraschini, PhD

  Fluminense Federal University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Prospective, parallel-arm, randomized controlled trial

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 30, 2019
• Study Start: April 15, 2017
• Primary Completion: August 15, 2019
• Study Completion: November 15, 2019
• Last Updated: December 30, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)