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Clinical Trials/NCT06165692
NCT06165692
Completed
Not Applicable

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

Amerigo Giudice1 site in 1 country31 target enrollmentOctober 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Facial Swelling
Sponsor
Amerigo Giudice
Enrollment
31
Locations
1
Primary Endpoint
Facial swelling qualitative analysis
Status
Completed
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 1, 2022
End Date
October 31, 2023
Last Updated
2 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Sponsor
Amerigo Giudice
Responsible Party
Sponsor Investigator
Principal Investigator

Amerigo Giudice

Professor

University Magna Graecia

Eligibility Criteria

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

Outcomes

Primary Outcomes

Facial swelling qualitative analysis

Time Frame: 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

Time Frame: 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

Time Frame: 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 Outcomes

  • 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 Sites (1)

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