Platelet Rich Fibrin (PRF) in Socket Preservation Technique

Alveolar Bone Loss Clinical Trial

Official title:

The Use of Platelet-Rich Fibrin as Solely Filling Material in Socket Preservation Technique: a Randomized-controlled Clinical Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT06173492
• Other study ID #: UNaples 401-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 11, 2023
• Est. completion date: November 30, 2024

Study information

• Verified date: December 2023
• Source: University of Naples
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The loss of a tooth or change in its function is lead to a change in alveolar ridge's height and volume. Socket preservation (SP) is a procedure designed to prevent or limit alteration of the post-extraction bone ridge to achieve an optimal prosthetic implant rehabilitation. The aim of this randomized-controlled clinical trial is to suggest that platelet rich fibrin (PRF) as solely grafting material may be a valid tool in this technique.

Description:

80 patients with mandibular or maxillary premolars that need to be extracted will be recruited. All patients will be randomly treated by using two different therapeutic approaches, thereby yielding two different study groups, each of which is composed of 40 cases: in the test group the socket preservation technique with PRF will be performed, in control group the post-extraction socket is left healing spontaneously without performing socket preservation. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 80
• Est. completion date: November 30, 2024
• Est. primary completion date: May 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Mandibular or maxillary premolars that need to be extracted due to endodontic failure, caries or fractures and will need to be replaced with a dental implant after 3 months of healing
• 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:

• Significant medical conditions contraindicating surgery
• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss
• Tooth Extraction

Intervention

Procedure:
• 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.

Device:
• Platelet Rich Fibrin
The clot obtained by centrifugation is made into PRF cylinders and inserted into the socket and compacted.

Locations

Country	Name	City	State
Italy	Gilberto Sammartino	Naples

Sponsors (1)

Lead Sponsor	Collaborator
University of Naples

Country where clinical trial is conducted

Italy, 

References & Publications (6)

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. — View Citation

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;1 — View Citation

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. — View Citation

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 — View Citation

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. Ep — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Periodontal probe - alveolar crest distance	Vertical distance measured with a periodontal probe from the alveolar crest (AC) to a reference periodontal probe (P) connecting the cement-enamel junction (CEJ) of the teeth adjacent.	Immediately after surgery, 3 months after surgery
Primary	Width	Horizontal alveolar ridge thickness from the external face of the buccal wall to the outer face of the lingual side is measured with a hand caliper, 1 mm apically from the alveolar ridge in the central area.	Immediately after surgery, 3 months after surgery
Primary	Vestibular bone wall thickness	It is measured with a hand caliper at the center of the vestibular wall, 1 mm apically from the ridge.	Immediately after surgery, 3 months after surgery
Secondary	Wound healing index	Landry index including description from a "Very poor" to an "Excellent" wound healing	3, 7, 14, 28 days after surgery