Platelet Rich Fibrin (PRF) in Socket Preservation Technique
NCT ID: NCT06173492
Last Updated: 2023-12-21
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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ACTIVE_NOT_RECRUITING
NA
80 participants
INTERVENTIONAL
2023-01-11
2024-11-30
Brief Summary
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Detailed Description
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A software will be used to produce a random sequence of 80 integer numbers without duplicates generated by a software and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated either to test or control group. All patients are informed by the written consent obtained that they could be causally allocated to one of the two groups.
Before extraction, patients should undergo to periodontal treatment and instrumental investigations such as orthopantomography.
After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the bone cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and the granulation tissue are removed.
In the test group, a blood collection of 40 ml will be performed and PRF is made according to the manufacturer instructions.
One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements immediately after surgery and three months later.
Patients will be checked at 3 days, 1 week after surgery (removal of sutures), 14 days after surgery, 28 days after surgery and at 3 months after surgery (at the time of implant placement).
A Cone Beam Computed Tomography (CBCT) is prescribed immediately after surgery and 3 months after surgery before implant placement.
Differences between the two analysed groups will be evaluate by test t-student through a statistic software.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Socket ridge preservation with PRF
40 ml of blood is drawn and collected in plastic tubes of 10 ml. The tubes are placed in a centrifuge at 2700 rpm for 12 minutes to get the clot of fibrin. After extraction, the clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.
Dental extraction
After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.
Platelet Rich Fibrin
The clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.
Spontaneous healing
No treatment is applied. The socket is made to heal spontaneously.
Dental extraction
After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.
Interventions
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Dental extraction
After local anesthesia (mepivacaine 2%), the tooth is extracted atraumatically with levers and forceps taking care to preserve the cortex. The roots of multi-rooted teeth are separated before extraction. The pocket epithelium and granulation tissue inside the socket are removed.
Platelet Rich Fibrin
The clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.
Eligibility Criteria
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Inclusion Criteria
* Full mouth plaque score ≤ 25% at onset
* Full mouth bleeding score ≤ 25% at onset
* Integrity of the alveolar walls after extraction
* Vestibular wall thickness \< 1 mm
* Patients able to understand and sign informed consensus
Exclusion Criteria
* Pregnancy and breastfeeding
* Tobacco smoking (\>15 cigarettes per day)
* Immunocompromised patients
* Alcohol and drug abuse
* Uncooperative patients
* Periodontally compromised patients
* Acute abscesses at the extraction site
* Other dental elements that are not premolars
* Patients who do not show up for scheduled checkups
18 Years
ALL
Yes
Sponsors
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University of Naples
OTHER
Responsible Party
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Gilberto Sammartino
Full professor
Principal Investigators
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Gilberto Sammartino
Role: PRINCIPAL_INVESTIGATOR
Federico II University
Locations
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Gilberto Sammartino
Naples, , Italy
Countries
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References
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Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x.
Chiapasco M, Zaniboni M, Rimondini L. Dental implants placed in grafted maxillary sinuses: a retrospective analysis of clinical outcome according to the initial clinical situation and a proposal of defect classification. Clin Oral Implants Res. 2008 Apr;19(4):416-28. doi: 10.1111/j.1600-0501.2007.01489.x. Epub 2008 Feb 11.
Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
Cortellini P, Pini Prato G, Baldi C, Clauser C. Guided tissue regeneration with different materials. Int J Periodontics Restorative Dent. 1990;10(2):136-51. No abstract available.
Zhang Y, Ruan Z, Shen M, Tan L, Huang W, Wang L, Huang Y. Clinical effect of platelet-rich fibrin on the preservation of the alveolar ridge following tooth extraction. Exp Ther Med. 2018 Mar;15(3):2277-2286. doi: 10.3892/etm.2018.5696. Epub 2018 Jan 4.
Maiorana C, Poli PP, Deflorian M, Testori T, Mandelli F, Nagursky H, Vinci R. Alveolar socket preservation with demineralised bovine bone mineral and a collagen matrix. J Periodontal Implant Sci. 2017 Aug;47(4):194-210. doi: 10.5051/jpis.2017.47.4.194. Epub 2017 Aug 11.
Other Identifiers
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UNaples 401-19
Identifier Type: -
Identifier Source: org_study_id