Facial SwellingNCT06165692
The Use of Platelet-rich-fibrin in Lower Third Molar Surgery.
A study testing PRF in people with Facial Swelling and Tooth Position Anomalies, run by Amerigo Giudice at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 18 to 32 yearsHealthy volunteers can take part
- Conditions the study is for
- Facial Swelling, Tooth Position Anomalies, Tooth, Impacted
- What is being tested?
- PRF
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 31 Oct 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 32 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial
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.
- Conditions
- Facial Swelling, Tooth Position Anomalies, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion
- Being tested
- PRF
- Keywords
- third molar surgery, facial swelling, 3D facial swelling evaluation, PRF, tooth impacted, platelet rich fibrin
- Medical subject headings
- Tooth, Impacted, Tooth Avulsion
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRFBiological
Post-operative PRF placement in the post-extraction socket after third molar surgery
| Study group | Role | What they receive |
|---|---|---|
| Test Group | Experimental | Placement of PRF in the post-extraction socket after third molar surgery Receives: Biological: PRF |
| Control Group | No intervention | No positioning PRF in the post-extraction socket after third molar surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
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) .
Measured: 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) .
Measured: 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) .
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes (2)
Trismus analysis
To assess the effects of PRF administration on trismus (measured in cm)
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
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)
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2023
- Study start1 Oct 2022
- Primary completion1 Oct 2023
- Study completion31 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial SwellingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amerigo Giudice
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Amerigo Giudice, University Magna Graecia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06165692
- Sponsor's protocol ID
- 2/2023
- Status last verified
- Dec 2023
- First submitted
- 15 Nov 2023
- Last updated
- 11 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Platelet-rich-fibrin in Lower Third Molar Surgery: a Split-mouth Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06165692
- Acronym / sponsor ID
- 2/2023
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Amerigo GiudiceUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 1 Oct 2023 (actual)
- Study completion
- 31 Oct 2023 (actual)
- First posted
- 11 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | Experimental | Biological: PRFPlacement of PRF in the post-extraction socket after third molar surgery |
| Control Group | No intervention | –No positioning PRF in the post-extraction socket after third molar surgery |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PRFPost-operative PRF placement in the post-extraction socket after third molar surgery | Biological | Test Group |
Primary outcome
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) .
2 secondary outcomes
Trismus analysis
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Pain analysis with Visual analogue scale (VAS)
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2023.
- Individual participant dataSharing planned: No
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Perioperative Photobiomodulation in Facial Plastic Surgery
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRF in people with Facial Swelling and Tooth Position Anomalies, run by Amerigo Giudice at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Facial swelling qualitative analysis (time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2023.