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CompletedNCT06165692Updated Dec 11, 2023

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

An interventional study of PRF in Facial Swelling, Tooth Position Anomalies and Tooth, Impacted, sponsored by Amerigo Giudice. Completed at 1 site in Italy. Open to participants aged 18 Years to 32 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-11.

Sponsored by Amerigo Giudice · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
31
Allocation
Randomized
Ages
18 Years to 32 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

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

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Keywords

  • third molar surgery
  • facial swelling
  • 3D facial swelling evaluation
  • PRF
  • tooth impacted
  • platelet rich fibrin
03

Who can participate

Ages eligible
18 Years to 32 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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
04

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
31 participants (actual)

Study arms

  • Experimental
    Test Group

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

    Biological: PRF

  • No intervention
    Control Group

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

Interventions

  • BiologicalPRF

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

05

What researchers measure

Primary outcomes

  1. 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) .

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

  2. 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) .

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

  3. 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) .

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

Secondary outcomes

  1. Trismus analysis

    To assess the effects of PRF administration on trismus (measured in cm)

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

  2. 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)

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

06

Study locations

1 site
  • Magna Graecia University of Catanzaro
    Catanzaro, 88100, Italy
07

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT06165692
Lead sponsor
Amerigo Giudice
Responsible party
Amerigo Giudice (Professor, University Magna Graecia) — Sponsor-investigator
First posted
Dec 11, 2023
Start date
Oct 1, 2022
Primary completion
Oct 1, 2023
Completion
Oct 31, 2023
Last update
Dec 11, 2023

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.

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