Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin

NCT ID: NCT04033744

Last Updated: 2020-03-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-07
• Study Completion Date: 2019-07-19

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.

Conditions

Periodontal; Lesion; Periodontal Pocket; Molar, Third

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

PRF (platelet-rich fibrin)

PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar

Group Type: EXPERIMENTAL

extraction of mandibular third molar

Intervention Type: PROCEDURE

After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary

spontaneous healing

after the extraction of the third molar the socket will be left to heal spontaneously

Group Type: ACTIVE_COMPARATOR

extraction of mandibular third molar

Intervention Type: PROCEDURE

After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary

Interventions

extraction of mandibular third molar

After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Naples

OTHER

Sponsor Role: lead

Responsible Party

Gilberto Sammartino

Full Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gilberto Sammartino, Professor

Role: PRINCIPAL_INVESTIGATOR

Federico II University

Locations

Gilberto Sammartino

Naples, , Italy

Countries

Italy

References

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.

Reference Type: RESULT

PMID: 28635382 (View on PubMed)

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.

Reference Type: RESULT

PMID: 21718187 (View on PubMed)

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.

Reference Type: RESULT

PMID: 15944972 (View on PubMed)

Other Identifiers

56/15

Identifier Type: -

Identifier Source: org_study_id