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

Primary Purpose

Dental Diseases

Status
Completed
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
Alveolar socket preservation with Platelet-rich fibrin
Sponsored by
Universidade Federal Fluminense
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dental Diseases focused on measuring Tooth extraction, Platelet-rich fibrin, Soft tissue

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Dental Clinical Research Center of the Fluminense Federal University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Test group

Control Goroup

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Postoperative pain
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).
Number of consumed analgesic
Questionnaires were collected at the one week follow-up visit.

Full Information

First Posted
December 17, 2019
Last Updated
December 24, 2019
Sponsor
Universidade Federal Fluminense
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1. Study Identification

Unique Protocol Identification Number
NCT04212767
Brief Title
The Use of PRF in the Management of Soft Tissue Healing
Acronym
PRF
Official Title
The Use of Platelet-rich Fibrin in the Management of Soft Tissue Healing and Pain in Post-extraction Sockets: a Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
December 2019
Overall Recruitment Status
Completed
Study Start Date
April 15, 2017 (Actual)
Primary Completion Date
August 15, 2019 (Actual)
Study Completion Date
November 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal Fluminense

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Diseases
Keywords
Tooth extraction, Platelet-rich fibrin, Soft tissue

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, parallel-arm, randomized controlled trial
Masking
None (Open Label)
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
Post-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16)
Arm Title
Control Goroup
Arm Type
No Intervention
Arm Description
Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16).
Intervention Type
Procedure
Intervention Name(s)
Alveolar socket preservation with Platelet-rich fibrin
Other Intervention Name(s)
Platelet-Rich Fibrin
Intervention Description
The sockets of the test group will be filled with two platelet-rich fibrin membranes followed by suture
Primary Outcome Measure Information:
Title
Evaluation of the soft tissue epithelialization speed in post-extraction sockets
Description
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.
Time Frame
90 days
Secondary Outcome Measure Information:
Title
Postoperative pain
Description
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).
Time Frame
90 days
Title
Number of consumed analgesic
Description
Questionnaires were collected at the one week follow-up visit.
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vittorio Moraschini, PhD
Organizational Affiliation
Fluminense Federal University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Dental Clinical Research Center of the Fluminense Federal University
City
Niterói
State/Province
Rio De Janeiro
ZIP/Postal Code
24020-140
Country
Brazil

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
31471902
Citation
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.
Results Reference
background
PubMed Identifier
30742137
Citation
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.
Results Reference
background
PubMed Identifier
16504850
Citation
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.
Results Reference
result

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The Use of PRF in the Management of Soft Tissue Healing

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