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

NCT06165692 | Completed

• 1 other identifier: 2/2023
• Study Type: interventional
• Target: 31
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

third molar surgery; facial swelling; 3D facial swelling evaluation; PRF; tooth impacted; platelet rich fibrin

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• Trismus analysis

  Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

• Pain analysis with Visual analogue scale (VAS)

  Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery

Study Arms (2)

Test Group

EXPERIMENTAL

Placement of PRF in the post-extraction socket after third molar surgery

Biological: PRF

Control Group

NO INTERVENTION

No positioning PRF in the post-extraction socket after third molar surgery

Interventions

PRF BIOLOGICAL

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

Test Group

Eligibility Criteria

• Age: 18 Years - 32 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amerigo Giudice: lead

Study Sites (1)

Magna Graecia University of Catanzaro

Catanzaro, 88100, Italy

Location

MeSH Terms

Conditions

Tooth, Impacted; Tooth Avulsion

Condition Hierarchy (Ancestors)

Tooth Diseases; Stomatognathic Diseases; Tooth Injuries; Wounds and Injuries

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 15, 2023
• First Posted: December 11, 2023
• Study Start: October 1, 2022
• Primary Completion: October 1, 2023
• Study Completion: October 31, 2023
• Last Updated: December 11, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)