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
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 |
Verified date | December 2023 |
Source | University Magna Graecia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
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 |
Country | Name | City | State |
---|---|---|---|
Italy | Magna Graecia University of Catanzaro | Catanzaro |
Lead Sponsor | Collaborator |
---|---|
Amerigo Giudice |
Italy,
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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