Facial SwellingNCT07764757
Platelet-Rich Fibrin as an Antibiotic Delivery Vehicle in Mandibular Third Molar Surgery
A study testing Antibiotic-enriched Platelet-Rich Fibrin (PRF) and Platelet-Rich Fibrin (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 evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth 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?
- Antibiotic-enriched Platelet-Rich Fibrin (PRF) and Platelet-Rich Fibrin (PRF)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteItaly
- Study dates
- 1 Nov 2025to 20 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Healthy patients (ASA I) according to the American Society of Anesthesiologists classification.
- Age 18-32 years.
- Ability to provide written informed consent.
- Bilateral mandibular third molars requiring extraction for prophylactic, therapeutic, or strategic reasons.
- Complete root development of mandibular third molars (Shumaker Stage H).
- Availability of diagnostic-quality CBCT scans with adequate field of view (17 × 20).
- Mandibular third molars classified as having conventional or moderate surgical difficulty according to Juodzbalys and Daugela classification.
Who cannot join
- Known allergy to corticosteroids.
- Immunosuppression or immunocompromised conditions.
- Acute infection at the mandibular third molar extraction sites.
- Current or previous intravenous amino-bisphosphonate therapy.
- Psychiatric disorders.
- Thrombocytopenia (platelet count <40,000/µL), thrombocytosis, or other coagulation disorders.
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- Severe hepatic cirrhosis, advanced chronic renal failure, or uncontrolled -diabetes mellitus.
- Pregnancy or breastfeeding.
- Requirement for additional regenerative procedures (e.g., bone grafting).
- Localized facial malformations involving the cheek region.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
The present study aims to evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth clinical trial.
- Conditions
- Facial Swelling, Tooth Position Anomalies, Tooth, Impacted, Tooth Extraction Status Nos, Tooth Avulsion
- Being tested
- Antibiotic-enriched Platelet-Rich Fibrin (PRF), Platelet-Rich Fibrin (PRF)
- Keywords
- third molar surgery, facial swelling, 3D facial swelling evaluation, PRF, tooth impacted, platelet rich fibrin, antibiotic delivery
- 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.
Antibiotic-enriched Platelet-Rich Fibrin (PRF)Biological
Platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation and applied into the mandibular third molar extraction socket to provide local antibiotic delivery.
Platelet-Rich Fibrin (PRF)Biological
Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket.
| Study group | Role | What they receive |
|---|---|---|
| Test Group - Antibiotic and PRF | Experimental | Participants will receive platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation. The antibiotic-enriched PRF clot will be placed into the mandibular third molar extraction socket to provide local antibiotic delivery at the surgical site. Receives: Biological: Antibiotic-enriched Platelet-Rich Fibrin (PRF) |
| Control Group - PRF only | Active comparator | Participants will receive standard platelet-rich fibrin prepared without antibiotic addition. The PRF clot will be placed into the mandibular third molar extraction socket according to the same surgical protocol. Receives: Biological: Platelet-Rich Fibrin (PRF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of postoperative infection
Occurrence of postoperative infection following mandibular third molar surgery, assessed through clinical examination based on the presence of signs and symptoms of infection (e.g., purulent discharge, erythema, fever, or need for additional antibiotic therapy).
Measured: Up to 7 days after surgery
Facial swelling qualitative analysis
Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
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 postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on volumetric differences. Facial volume changes will be measured in cubic centimeters (cm³) through three-dimensional facial scan superimposition.
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 postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on linear measurements. Facial changes will be assessed by evaluating linear differences (mm) between preoperative and postoperative three-dimensional facial scans.
Measured: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Secondary outcomes (2)
Trismus analysis
To compare postoperative limitation of mouth opening between treatment groups following mandibular third molar surgery. Trismus will be assessed by measuring maximum mouth opening (MMO) in millimeters (mm).
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 compare postoperative pain intensity between treatment groups following mandibular third molar surgery. Pain will be assessed using a Visual Analog Scale (VAS), ranging from 0 (no pain) to 10 (worst possible pain).
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 posted14 Aug 2026
- Study start1 Nov 2025
- Primary completion1 Sep 2026 (estimated)
- Study completion20 Nov 2026 (estimated)
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, Investigator, Outcomes assessor
- 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
- NCT07764757
- Sponsor's protocol ID
- 23/2023
- Status last verified
- Jul 2026
- First submitted
- 10 Aug 2026
- Last updated
- 20 Aug 2026
- 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 20 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Antibiotic-Prepared Platelet-Rich Fibrin on Postoperative Recovery After Mandibular Third Molar Surgery: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07764757
- Acronym / sponsor ID
- 23/2023
- 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, antibiotic delivery
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Amerigo GiudiceUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- 1 Sep 2026 (estimated)
- Study completion
- 20 Nov 2026 (estimated)
- First posted
- 14 Aug 2026 (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 evaluate the effect of platelet-rich fibrin (PRF) used as a local antibiotic delivery vehicle on postoperative outcomes, including facial swelling, trismus, and pain, following mandibular third molar surgery in a randomized split-mouth clinical trial.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group - Antibiotic and PRF | Experimental | Biological: Antibiotic-enriched Platelet-Rich Fibrin (PRF)Participants will receive platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation. The antibiotic-enriched PRF clot will be placed into the mandibular third molar extraction socket to provide local antibiotic delivery at the surgical site. |
| Control Group - PRF only | Active comparator | Biological: Platelet-Rich Fibrin (PRF)Participants will receive standard platelet-rich fibrin prepared without antibiotic addition. The PRF clot will be placed into the mandibular third molar extraction socket according to the same surgical protocol. |
Who may qualify
- Ages
- 18 to 32 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Healthy patients (ASA I) according to the American Society of Anesthesiologists classification.
- Age 18-32 years.
- Ability to provide written informed consent.
- Bilateral mandibular third molars requiring extraction for prophylactic, therapeutic, or strategic reasons.
- Complete root development of mandibular third molars (Shumaker Stage H).
Key exclusion criteria (10 listed)
- Known allergy to corticosteroids.
- Immunosuppression or immunocompromised conditions.
- Acute infection at the mandibular third molar extraction sites.
- Current or previous intravenous amino-bisphosphonate therapy.
- Psychiatric disorders.
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 |
|---|---|---|
| Antibiotic-enriched Platelet-Rich Fibrin (PRF)Platelet-rich fibrin prepared with the addition of antibiotic prior to centrifugation and applied into the mandibular third molar extraction socket to provide local antibiotic delivery. | Biological | Test Group - Antibiotic and PRF |
| Platelet-Rich Fibrin (PRF)Standard platelet-rich fibrin prepared without antibiotic addition and applied into the mandibular third molar extraction socket. | Biological | Control Group - PRF only |
Primary outcome
Incidence of postoperative infection
Time frame: Up to 7 days after surgery
Occurrence of postoperative infection following mandibular third molar surgery, assessed through clinical examination based on the presence of signs and symptoms of infection (e.g., purulent discharge, erythema, fever, or need for additional antibiotic therapy).
Facial swelling qualitative analysis
Time frame: Change from baseline (before surgery) at 2 day after surgery and at 7 days after surgery
Change in facial volume from baseline, assessed by three-dimensional facial scan superimposition and expressed as colorimetric variation between the preoperative and postoperative scans.
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 postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on volumetric differences. Facial volume changes will be measured in cubic centimeters (cm³) through three-dimensional facial scan superimposition.
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 postoperative facial swelling between treatment groups using quantitative three-dimensional analysis based on linear measurements. Facial changes will be assessed by evaluating linear differences (mm) between preoperative and postoperative three-dimensional facial scans.
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
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Aug 2026.
- Individual participant dataSharing planned: No
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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 Antibiotic-enriched Platelet-Rich Fibrin (PRF) and Platelet-Rich Fibrin (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 7 inclusion and 10 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: under way, not looking for participants, as of the sponsor's last update on 20 Aug 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Incidence of postoperative infection (time frame: Up to 7 days after surgery). The study lists 4 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 20 Aug 2026; AzTrials last refreshed its copy on 8 Nov 2026.