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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT06165692
Other study ID # 2/2023
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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