Clinical trial NCT04033744: Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Official title: Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Periodontal; Lesion
Periodontal Pocket
Molar, Third
Keywords: Molar, Third
Platelet-Rich Fibrin
Lead sponsor: University of Naples
Sponsor class: OTHER
First posted: 2019-07-26
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

Brief summary: The extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.

Detailed description: Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.

CAL at the distal surface of the lower second molar is chosen as primary outcome.

Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth \>7 mm and a probing clinical attachment level \>6mm.

This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 integer numbers without duplicates generated from atmospheric noise 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 group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.

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 (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.

Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.

Eligibility criteria: Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old

* Periodontally health patients and treated periodontally compromised patients
* Enrollment on a regular supportive periodontal therapy (SPT) program.
* Full-mouth plaque score (FMPS)\< 25% at baseline;
* Full-mouth bleeding score (FMBS)\< 25% at baseline;
* Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
* Intact buccal and lingual cortical bone of the post-extraction site

Exclusion Criteria:

* General contra-indications for surgery (systemic disease, compromised immune system etc);
* Tobacco smoking
* Pregnancy and lactation
* Untreated periodontal conditions;
* Acute infection in the site of the extraction
* Patients taking any medications which might interfere with coagulation
* Platelet count \< 150000/mm3

Primary outcomes:
measure: Clinical attachment level change
timeFrame: 12 and 18 weeks
Secondary outcomes:
measure: probing depth change
timeFrame: 12 and 18 weeks
measure: gingival recession change
timeFrame: 12 and 18 weeks
Other outcomes:
Locations:
city: Naples
country: Italy
facility: Gilberto Sammartino
Study officials:
affiliation: Federico II University
name: Gilberto Sammartino, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
citation: Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
citation: Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.