The Use of PRF in the Management of Soft Tissue Healing
NCT ID: NCT04212767
Last Updated: 2019-12-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
32 participants
INTERVENTIONAL
2017-04-15
2019-11-15
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Test group
Post-extraction sockets covered with Platelet-Rich Fibrin membrane (n=16)
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
Control Goroup
Post-extraction sockets left to spontaneous healing/clot and primary closure (n=16).
No interventions assigned to this group
Interventions
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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 Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Participants needing molar extraction in the mandible or maxilla region.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Universidade Federal Fluminense
OTHER
Responsible Party
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Vittorio Moraschini Filho
Principal Investigator
Principal Investigators
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Vittorio Moraschini, PhD
Role: PRINCIPAL_INVESTIGATOR
Fluminense Federal University
Locations
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Dental Clinical Research Center of the Fluminense Federal University
Niterói, Rio de Janeiro, Brazil
Countries
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References
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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.
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.
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.
Other Identifiers
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PRF1
Identifier Type: -
Identifier Source: org_study_id