The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.

The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial.

Study Overview

• Status: Completed
• Conditions: Tooth, Impacted; Tooth Position Anomalies; Facial Swelling; Tooth Extraction Status Nos; Tooth Avulsion
• Intervention / Treatment: Biological: PRF

Detailed Description

The present study aims to analyze the effect of PRF (Platelet-rich-fibrin) in terms of facial swelling, trismus and pain after surgical removal of mandibular third molar (M3M) in a split-mouth randomized controlled clinical trial. Facial swelling will be assessed using an innovative three-dimensional digital technique.

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Italy
  • Catanzaro, Italy, 88100
    • Magna Graecia University of Catanzaro

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Patients aged 18 to 32 years who required both M3M extractions were recruited
• Good health status
• Indication to surgical extraction of both M3M
• Complete root formation
• Surgical risk level classified as "Conventional" or "Moderate" according to Daugela et al. classification

Exclusion Criteria:

• Person under the age of 18 or over 32
• Allergy or contraindications to administration of corticosteroids
• Acute infection in any of the teeth to be extracted
• Patients with chronic liver disease, diabetes, immune system dysfunction, or haematological disease
• Pregnancy or breastfeeding
• History of treatment with antiresorptive drugs
• Chronic kidney disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Test Group; Placement of PRF in the post-extraction socket after third molar surgery	Biological: PRF; Post-operative PRF placement in the post-extraction socket after third molar surgery
No Intervention: Control Group; No positioning PRF in the post-extraction socket after third molar surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial swelling qualitative analysis	To compare the effectiveness of PRF in reducing facial swelling using qualitative three-dimensional analysis (measured by colorimetric variation given by the overlapping volumes) .	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - volumetric differences	To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis ( volumes measured in cm3) .	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Facial swelling quantitative analysis - linear differences	To compare the effectiveness of PRF in reducing facial swelling using quantitative three-dimensional analysis (linear differences measured in cm2) .	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trismus analysis	To assess the effects of PRF administration on trismus (measured in cm)	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)	To assess the effects of PRF administration on pain (measured by VAS-score from 0 to 10 point, with 10 as the worst outcome)	Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Collaborators and Investigators

• Sponsor: Amerigo Giudice

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Actual): October 1, 2023
• Study Completion (Actual): October 31, 2023

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: December 8, 2023
• First Posted (Estimated): December 11, 2023

Study Record Updates

• Last Update Posted (Estimated): December 11, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: PRF; platelet rich fibrin; third molar surgery; facial swelling; 3D facial swelling evaluation; tooth impacted
• Additional Relevant MeSH Terms: Wounds and Injuries; Stomatognathic Diseases; Tooth Diseases; Tooth Injuries; Tooth, Impacted; Tooth Avulsion
• Other Study ID Numbers: 2/2023

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No