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

Tooth Extraction Status Nos Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06165692
• Other study ID #: 2/2023
• Status: Completed
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: October 31, 2023

Study information

• Verified date: December 2023
• Source: University Magna Graecia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 31
• Est. completion date: October 31, 2023
• Est. primary completion date: October 1, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 32 Years

Eligibility

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

Related Conditions & MeSH terms

• Facial Swelling
• Tooth Avulsion
• Tooth Extraction Status Nos
• Tooth Position Anomalies
• Tooth, Impacted

Intervention

Biological:
• PRF
Post-operative PRF placement in the post-extraction socket after third molar surgery

Locations

Country	Name	City	State
Italy	Magna Graecia University of Catanzaro	Catanzaro

Sponsors (1)

Lead Sponsor	Collaborator
Amerigo Giudice

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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