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

Not Applicable

Completed

• Conditions: Tooth Avulsion; Tooth Position Anomalies; Tooth, Impacted; Facial Swelling; Tooth Extraction Status Nos
• Interventions: Biological: PRF

• Registration Number: NCT06165692
• Lead Sponsor: Amerigo Giudice

Brief Summary

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.

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 Timeline

• Study Start: 2022-10-01
• Primary Completion: 2023-10-01
• Study Completion: 2023-10-31
• Study First Submitted: 2023-11-15
• Status Verified: 2023-12
• Study First Submitted QC: 2023-12-08
• Last Update Submitted: 2023-12-08
• Study First Posted: 2023-12-11
• Last Update Posted: 2023-12-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 31

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Test Group	PRF	Placement of PRF in the post-extraction socket after third molar surgery

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Magna Graecia University of Catanzaro; 🇮🇹 Catanzaro, Italy