Periodontal; LesionNCT04033744
Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
A study testing extraction of mandibular third molar in people with Periodontal; Lesion and Periodontal Pocket, run by University of Naples at 1 site in Italy.
Trial summary
The extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third… Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal; Lesion, Periodontal Pocket, Molar, Third
- What is being tested?
- extraction of mandibular third molar
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteItaly
- Study dates
- 7 Jan 2018to 19 Jul 2019
- 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
None listed.
Who cannot join
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Pregnancy and lactation
- Untreated periodontal conditions;
- Acute infection in the site of the extraction
- Patients taking any medications which might interfere with coagulation
- Platelet count < 150000/mm3
Trial locations and contacts
1 site in 1 country.
About this study
The extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.
Read the detailed description
Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.
CAL at the distal surface of the lower second molar is chosen as primary outcome.
Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth >7 mm and a probing clinical attachment level >6mm.
This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 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 either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.
One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.
- Conditions
- Periodontal; Lesion, Periodontal Pocket, Molar, Third
- Being tested
- extraction of mandibular third molar
- Keywords
- Molar, Third, Platelet-Rich Fibrin
- Medical subject headings
- Periodontal Pocket
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
| Study group | Role | What they receive |
|---|---|---|
| PRF (platelet-rich fibrin) | Experimental | PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar Receives: Procedure: extraction of mandibular third molar |
| spontaneous healing | Active comparator | after the extraction of the 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.
Clinical attachment level change
the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction.
the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Measured: 12 and 18 weeks
Secondary outcomes (2)
probing depth change
The probing depth is the distance from the free end of the gingival margin to the bottom of the periodontal pocket. The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Measured: 12 and 18 weeks
gingival recession change
The distance between the cemento-enamel junction and gingival margin gives the level of recession.
The measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
Measured: 12 and 18 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2019
- Study start7 Jan 2018
- Primary completion19 Jul 2019
- Study completion19 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Periodontal; LesionStudies 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
- 18 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
- NCT04033744
- Sponsor's protocol ID
- 56/15
- Status last verified
- Jul 2019
- First submitted
- 22 Jul 2019
- Last updated
- 25 Mar 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
PubMed 28635382Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
PubMed 21718187Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.
PubMed 15944972
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin
- ClinicalTrials.gov ID
- NCT04033744
- Acronym / sponsor ID
- 56/15
- Conditions
- Periodontal; Lesion, Periodontal Pocket, Molar, Third
- Keywords
- Molar, Third, Platelet-Rich Fibrin
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of NaplesUniversity, hospital or other
- Study start
- 7 Jan 2018 (actual)
- Primary completion
- 19 Jul 2019 (actual)
- Study completion
- 19 Jul 2019 (actual)
- First posted
- 26 Jul 2019 (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 extraction of deep impacted mandibular third molar may cause periodontal defects at the distal root of the second molar. The aim of this study was to evaluate the ability of platelet-rich fibrin (PRF) in preventing periodontal complications at the distal root of the second molar adjacent to the extracted third molar.
Detailed description
Eighteen young patients with bilateral impacted mandibular third molars will be selected. All 36 cases of impactions will be selected for a split mouth study and randomly treated by using 2 different therapeutic approaches, thereby yielding 2 different study groups, each of which is composed of 18 cases: in one side the post-extraction socket is left healing spontaneously, on the other side the socket is filled with PRF.
CAL at the distal surface of the lower second molar is chosen as primary outcome.
Criteria will be the presence of a pocket distal to the mandibular second molar with a probing depth >7 mm and a probing clinical attachment level >6mm.
This study was designed as a single-blind research since subjects will be unaware of their treatment allocation. A software will be used to produce a random sequence of 18 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 either to group 1 (PRF on the right side, spontaneous healing on the left side), for allocation numbers 1-9, or group 2 (spontaneous healing on the right side, PRF on the left side), for allocation numbers 10-18.
One clinician, not involved in patient treatment and not aware of what therapeutic approach used for the different sites of treatment, will perform all clinical measurements (PD, CAL, gingival recession, plaque index and gingival bleeding index) before and after 12 and 18 weeks of surgery.
Clinical and radiographical measurements will be recorded at 12 and 18 weeks after the surgery. The Student t test will be used to compare the differences between the 2 groups.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PRF (platelet-rich fibrin) | Experimental | Procedure: extraction of mandibular third molarPRF will be used after the extraction of the third molar to prevent periodontal defects to second molar |
| spontaneous healing | Active comparator | Procedure: extraction of mandibular third molarafter the extraction of the 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 (0 listed)
Key exclusion criteria (7 listed)
- General contra-indications for surgery (systemic disease, compromised immune system etc);
- Tobacco smoking
- Pregnancy and lactation
- Untreated periodontal conditions;
- Acute infection in the site of the extraction
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 | PRF (platelet-rich fibrin), spontaneous healing |
Primary outcome
Clinical attachment level change
Time frame: 12 and 18 weeks
the clinical attachment level is the distance between the gingival margin to the cemento-enamel junction. the measurement is made by using a Williams periodontal probe. Differences in changes are measured from baseline to 12 and 18 weeks.
2 secondary outcomes
probing depth change
Time frame: 12 and 18 weeks
gingival recession change
Time frame: 12 and 18 weeks
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 25 Mar 2020.
- Results publication: PubMed 28635382Cabaro S, D'Esposito V, Gasparro R, Borriello F, Granata F, Mosca G, Passaretti F, Sammartino JC, Beguinot F, Sammartino G, Formisano P, Riccitiello F. White cell and platelet content affects the release of bioactive factors in different blood-derived scaffolds. Platelets. 2018 Jul;29(5):463-467. doi: 10.1080/09537104.2017.1319046. Epub 2017 Jun 21.
- Results publication: PubMed 21718187Sammartino G, Dohan Ehrenfest DM, Carile F, Tia M, Bucci P. Prevention of hemorrhagic complications after dental extractions into open heart surgery patients under anticoagulant therapy: the use of leukocyte- and platelet-rich fibrin. J Oral Implantol. 2011 Dec;37(6):681-90. doi: 10.1563/AAID-JOI-D-11-00001. Epub 2011 Jun 30.
- Results publication: PubMed 15944972Sammartino G, Tia M, Marenzi G, di Lauro AE, D'Agostino E, Claudio PP. Use of autologous platelet-rich plasma (PRP) in periodontal defect treatment after extraction of impacted mandibular third molars. J Oral Maxillofac Surg. 2005 Jun;63(6):766-70. doi: 10.1016/j.joms.2005.02.010.
- 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 in people with Periodontal; Lesion and Periodontal Pocket, 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 0 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 25 Mar 2020. 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?
Clinical attachment level change (time frame: 12 and 18 weeks). 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 NCT04033744, which also lists 3 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 25 Mar 2020.