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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT06173492
Other study ID # UNaples 401-19
Secondary ID
Status Active, not recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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