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

NCT04033744 | Completed

• 1 other identifier: 56/15
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontal; Lesion; Periodontal Pocket; Molar, Third

Keywords

Molar, Third; Platelet-Rich Fibrin

Outcome Measures

Primary Outcomes (1)

• Clinical attachment level change

  the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.

  12 and 18 weeks

Secondary Outcomes (2)

• probing depth change

  12 and 18 weeks

• gingival recession change

  12 and 18 weeks

Study Arms (2)

PRF (platelet-rich fibrin)

EXPERIMENTAL

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

Procedure: extraction of mandibular third molar

spontaneous healing

ACTIVE COMPARATOR

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

Procedure: extraction of mandibular third molar

Interventions

extraction of mandibular third molar 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

PRF (platelet-rich fibrin); spontaneous healing

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Naples: lead

Study Sites (1)

Gilberto Sammartino

Naples, 80131, Italy

Location

Related Publications (3)

• 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.

  PMID: 28635382 RESULT

• 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.

  PMID: 21718187 RESULT

• 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.

  PMID: 15944972 RESULT

MeSH Terms

Conditions

Periodontal Pocket

Condition Hierarchy (Ancestors)

Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Gilberto Sammartino, Professor

  Federico II University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: One clinician, not involved in patient treatment and not aware of what therapeutic approach was used for the different sites of treatment, performed all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor

Study Record Dates

• First Submitted: July 22, 2019
• First Posted: July 26, 2019
• Study Start: January 7, 2018
• Primary Completion: July 19, 2019
• Study Completion: July 19, 2019
• Last Updated: March 25, 2020

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)