Molar, ThirdNCT06073535
The Use of Injectable-Platelet Rich Fibrin (i-PRF) in the Lower Third Molar Extraction
A study testing Extraction of mandibular third molar and i-PRF in people with Molar, Third and Postoperative Complications, run by University of Naples at 1 site in Italy.
Trial summary
Lower third molar extraction is one of the most frequently performed surgical procedures in dentistry. Common sequelae, including pain, swelling and trismus, can severely affect patients' quality of life during the immediate postoperative period. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Molar, Third, Postoperative Complications
- What is being tested?
- Extraction of mandibular third molar and i-PRF
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 27 Feb 2023to 29 Dec 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Need for extraction of totally or partially impacted lower third molar
- Equivalent degree of difficulty of lower third molar extraction
- Patients able to understand and sign informed consent
Who cannot join
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Alcohol and drug abuse
- Pregnancy and breastfeeding
- Patients taking any medications which might interfere with healing
- Dysplastic processes in the affected tooth elements
Show all 10Show fewer
- Non-cooperative patients
- EXCLUSION CRITERIA DURING FOLLOW-UP - Patients who do not adhere throughout the duration of follow-up to the specialist visits
- POSTOPERATIVE EXCLUSION CRITERIA
- Taking more than two doses of prescribed anti-inflammatory/analgesic medication
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Usefulness of Injectable-Platelet Rich Fibrin in the Lower Third Molar Extraction: a Randomized-controlled Clinical Study.
Lower third molar extraction is one of the most frequently performed surgical procedures in dentistry. Common sequelae, including pain, swelling and trismus, can severely affect patients' quality of life during the immediate postoperative period.
The aim of this randomized-controlled trial is to clinically evaluate the reduction of lower third molar extraction-related complications, such as swelling and pain, and wound healing, following submucosal infiltration of injectable platelet rich fibrin.
Read the detailed description
Forty young patients with a partially or totally impacted lower third molar, with an equivalent degree of difficulty, will be selected. All patients will be randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 20 cases: in the first group, the extraction socket will be left healing spontaneously, while in the other side the socket will be filled with i-PRF.
This study was designed as a double-blind research since the investigator will be unaware of their treatment allocation before surgery, and one clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform clinical measurement of the outcomes on the surgery day, 3th and 7th days after surgery.
A software will be used to produce a random sequence of 20 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated to group 1 or group 2.
Prior to surgery, photographic documentation consisting of frontal extraoral photograph, extraoral latero-lateral photograph of the surgery site, extraoral latero-lateral photograph of the opposite site will be performed.
The swelling will be measured summing two linear measurements of distance between Tragus and Pogonion and then Gonion and Commissura labialis points.
Immediately after surgery, the surgeon opens the envelope containing the information about the patient's group membership. In case of i-PRF group, 20 mL will be prepared.
Everyday after surgery, each patients will compile the visual analogic scale to evaluate the pain score.
On 3th and 7th day after surgery, linear measurements of swelling will be taken. Then, on 3th, 7th, 14th, 28th days the wound healing index by Landry will be evaluate.
The Student t test will be used to compare the differences between the two analysed groups. Potential differences between pain, swelling and wound healing based on gender, age and time of surgery will be assessed by using Student's t-test and one-way analysis of variance (ANOVA).
- Conditions
- Molar, Third, Postoperative Complications
- Being tested
- Extraction of mandibular third molar, i-PRF
- Keywords
- Molar, third, Postoperative complications, Swelling, Pain, Platelet-rich fibrin
- Medical subject headings
- Postoperative Complications, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Extraction of mandibular third molarProcedure or surgery
After loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle.
An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary.
i-PRFDevice
20 ml of venous blood will be drawn from the ante-cubital vein of all patients and collected in 2 plastic tubes (Vacutainer, Becton\& Dickinson, Rutherford, NJ) containing no anticoagulant or gelling agent. The tubes will be placed in a centrifuge (DUO Centrifuge, Nice, France) at 700 round per minute for 3 min, at the end of which time the blood will be separated into 2 fractions: the layer of injectable liquid i-PRF, which is more superficial, and the layer of red blood cells, in the deep part. From each tube, i-PRF will be withdrawn using a sterile syringe and it will be infiltrated into the lesion.
| Study group | Role | What they receive |
|---|---|---|
| i-PRF | Experimental | i-PRF will be used after the extraction of the third molar to reduce postoperative complications (swelling, pain) and wound healing. Receives: Procedure: Extraction of mandibular third molar; Device: i-PRF |
| Spontaneous healing | Active comparator | After the extraction of the lower third molar the socket will be left to heal spontaneously. Receives: Procedure: Extraction of mandibular third molar |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative swelling
Measurements will be made with a flexible ruler taking as reference the diagonals joining Tragus and Pogonion; Gonion and Labial Commissura. Swelling will be calculated as the sum of these diagonals.
Measured: Measurements will be taken before surgery, on day 3 and day 7.
Secondary outcomes (1)
Postoperative pain
Pain was assessed with a visual analogic scale (VAS) from 0 (absence of pain) to 10 (severe pain).
Measured: Everyday after surgery until 7th day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2023
- Study start27 Feb 2023
- Primary completion4 Sep 2023
- Study completion29 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Molar, ThirdStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Naples
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gilberto Sammartino, University of Naples
- Investigators
- Gilberto Sammartino, Professor, Principal investigator, Federico II University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06073535
- Sponsor's protocol ID
- UNaples
- Status last verified
- Dec 2023
- First submitted
- 25 Sep 2023
- Last updated
- 21 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sammartino G, Gasparro R, Marenzi G, Trosino O, Mariniello M, Riccitiello F. Extraction of mandibular third molars: proposal of a new scale of difficulty. Br J Oral Maxillofac Surg. 2017 Nov;55(9):952-957. doi: 10.1016/j.bjoms.2017.09.012. Epub 2017 Oct 18.
PubMed 29054564Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
PubMed 19089687Passaretti F, Tia M, D'Esposito V, De Pascale M, Del Corso M, Sepulveres R, Liguoro D, Valentino R, Beguinot F, Formisano P, Sammartino G. Growth-promoting action and growth factor release by different platelet derivatives. Platelets. 2014;25(4):252-6. doi: 10.3109/09537104.2013.809060. Epub 2013 Jul 15.
PubMed 23855408Dohan Ehrenfest DM, Bielecki T, Del Corso M, Inchingolo F, Sammartino G. Shedding light in the controversial terminology for platelet-rich products: platelet-rich plasma (PRP), platelet-rich fibrin (PRF), platelet-leukocyte gel (PLG), preparation rich in growth factors (PRGF), classification and commercialism. J Biomed Mater Res A. 2010 Dec 15;95(4):1280-2. doi: 10.1002/jbm.a.32894. Epub 2010 Oct 5. No abstract available.
PubMed 20925082Farshidfar N, Jafarpour D, Firoozi P, Sahmeddini S, Hamedani S, de Souza RF, Tayebi L. The application of injectable platelet-rich fibrin in regenerative dentistry: A systematic scoping review of In vitro and In vivo studies. Jpn Dent Sci Rev. 2022 Nov;58:89-123. doi: 10.1016/j.jdsr.2022.02.003. Epub 2022 Mar 29.
PubMed 35368368
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Usefulness of Injectable-Platelet Rich Fibrin in the Lower Third Molar Extraction: a Randomized-controlled Clinical Study.
- ClinicalTrials.gov ID
- NCT06073535
- Acronym / sponsor ID
- UNaples
- Conditions
- Molar, Third, Postoperative Complications
- Keywords
- Molar, third, Postoperative complications, Swelling, Pain, Platelet-rich fibrin
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 27 Feb 2023 (actual)
- Primary completion
- 4 Sep 2023 (actual)
- Study completion
- 29 Dec 2023 (estimated)
- First posted
- 10 Oct 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.
Lower third molar extraction is one of the most frequently performed surgical procedures in dentistry. Common sequelae, including pain, swelling and trismus, can severely affect patients' quality of life during the immediate postoperative period.
The aim of this randomized-controlled trial is to clinically evaluate the reduction of lower third molar extraction-related complications, such as swelling and pain, and wound healing, following submucosal infiltration of injectable platelet rich fibrin.
Detailed description
Forty young patients with a partially or totally impacted lower third molar, with an equivalent degree of difficulty, will be selected. All patients will be randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 20 cases: in the first group, the extraction socket will be left healing spontaneously, while in the other side the socket will be filled with i-PRF.
This study was designed as a double-blind research since the investigator will be unaware of their treatment allocation before surgery, and one clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform clinical measurement of the outcomes on the surgery day, 3th and 7th days after surgery.
A software will be used to produce a random sequence of 20 integer numbers without duplicates generated from atmospheric noise and concealed in closed envelopes by one of the investigators. At the time of the patient's first surgery, the envelope will be opened and patient allocated to group 1 or group 2.
Prior to surgery, photographic documentation consisting of frontal extraoral photograph, extraoral latero-lateral photograph of the surgery site, extraoral latero-lateral photograph of the opposite site will be performed.
The swelling will be measured summing two linear measurements of distance between Tragus and Pogonion and then Gonion and Commissura labialis points.
Immediately after surgery, the surgeon opens the envelope containing the information about the patient's group membership. In case of i-PRF group, 20 mL will be prepared.
Everyday after surgery, each patients will compile the visual analogic scale to evaluate the pain score.
On 3th and 7th day after surgery, linear measurements of swelling will be taken. Then, on 3th, 7th, 14th, 28th days the wound healing index by Landry will be evaluate.
The Student t test will be used to compare the differences between the two analysed groups. Potential differences between pain, swelling and wound healing based on gender, age and time of surgery will be assessed by using Student's t-test and one-way analysis of variance (ANOVA).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| i-PRF | Experimental | Procedure: Extraction of mandibular third molar, Device: i-PRFi-PRF will be used after the extraction of the third molar to reduce postoperative complications (swelling, pain) and wound healing. |
| Spontaneous healing | Active comparator | Procedure: Extraction of mandibular third molarAfter the extraction of the lower third molar the socket will be left to heal spontaneously. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Need for extraction of totally or partially impacted lower third molar
- Equivalent degree of difficulty of lower third molar extraction
- Patients able to understand and sign informed consent
Key exclusion criteria (10 listed)
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Alcohol and drug abuse
- Pregnancy and breastfeeding
- Patients taking any medications which might interfere with healing
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 |
|---|---|---|
| Extraction of mandibular third molarAfter loco-regional anesthesia was administered, a full-thickness mucoperiosteal flap was raised. The flap incision was extended from the vestibular side of the retromolar trigon to the second molar, corresponding to its distolingual cusp. The incision continued intrasulcular at the second molar and proceeded with a release incision distally to the papilla between the first and second molars, on a 45° angle. An osteotomy using a Lindemann burr under constant irrigation, followed by an odontotomy using a diamond burr was performed, if necessary. | Procedure or surgery | Spontaneous healing, i-PRF |
| i-PRF20 ml of venous blood will be drawn from the ante-cubital vein of all patients and collected in 2 plastic tubes (Vacutainer, Becton\& Dickinson, Rutherford, NJ) containing no anticoagulant or gelling agent. The tubes will be placed in a centrifuge (DUO Centrifuge, Nice, France) at 700 round per minute for 3 min, at the end of which time the blood will be separated into 2 fractions: the layer of injectable liquid i-PRF, which is more superficial, and the layer of red blood cells, in the deep part. From each tube, i-PRF will be withdrawn using a sterile syringe and it will be infiltrated into the lesion. | Device | i-PRF |
Primary outcome
Postoperative swelling
Time frame: Measurements will be taken before surgery, on day 3 and day 7.
Measurements will be made with a flexible ruler taking as reference the diagonals joining Tragus and Pogonion; Gonion and Labial Commissura. Swelling will be calculated as the sum of these diagonals.
1 secondary outcome
Postoperative pain
Time frame: Everyday after surgery until 7th day.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Results publication: PubMed 29054564Sammartino G, Gasparro R, Marenzi G, Trosino O, Mariniello M, Riccitiello F. Extraction of mandibular third molars: proposal of a new scale of difficulty. Br J Oral Maxillofac Surg. 2017 Nov;55(9):952-957. doi: 10.1016/j.bjoms.2017.09.012. Epub 2017 Oct 18.
- Results publication: PubMed 19089687Dohan Ehrenfest DM, de Peppo GM, Doglioli P, Sammartino G. Slow release of growth factors and thrombospondin-1 in Choukroun's platelet-rich fibrin (PRF): a gold standard to achieve for all surgical platelet concentrates technologies. Growth Factors. 2009 Feb;27(1):63-9. doi: 10.1080/08977190802636713.
- Results publication: PubMed 23855408Passaretti F, Tia M, D'Esposito V, De Pascale M, Del Corso M, Sepulveres R, Liguoro D, Valentino R, Beguinot F, Formisano P, Sammartino G. Growth-promoting action and growth factor release by different platelet derivatives. Platelets. 2014;25(4):252-6. doi: 10.3109/09537104.2013.809060. Epub 2013 Jul 15.
- Results publication: PubMed 20925082Dohan Ehrenfest DM, Bielecki T, Del Corso M, Inchingolo F, Sammartino G. Shedding light in the controversial terminology for platelet-rich products: platelet-rich plasma (PRP), platelet-rich fibrin (PRF), platelet-leukocyte gel (PLG), preparation rich in growth factors (PRGF), classification and commercialism. J Biomed Mater Res A. 2010 Dec 15;95(4):1280-2. doi: 10.1002/jbm.a.32894. Epub 2010 Oct 5. No abstract available.
- Results publication: PubMed 35368368Farshidfar N, Jafarpour D, Firoozi P, Sahmeddini S, Hamedani S, de Souza RF, Tayebi L. The application of injectable platelet-rich fibrin in regenerative dentistry: A systematic scoping review of In vitro and In vivo studies. Jpn Dent Sci Rev. 2022 Nov;58:89-123. doi: 10.1016/j.jdsr.2022.02.003. Epub 2022 Mar 29.
- 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.
Gilberto Sammartino, Professor principal investigator
Federico II University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Extraction of mandibular third molar and i-PRF in people with Molar, Third and Postoperative Complications, run by University of Naples 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 3 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: status not confirmed, as of the sponsor's last update on 21 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?
Results are not available in the source record.
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?
Postoperative swelling (time frame: Measurements will be taken before surgery, on day 3 and day 7.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06073535, which also lists 5 linked publications.
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 21 Dec 2023.