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Prevention of Mandibular Third Molar Extraction- Associated Periodontal Defects Using Platelet-Rich Fibrin

24. marts 2020 opdateret af: Gilberto Sammartino, University of Naples
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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

18

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Italien
      • Naples, Italien, 80131
        • Gilberto Sammartino

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 35 år (Voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Inclusion criteria Patients of both genders and any race, between 18 and 35 year-old

  • Periodontally health patients and treated periodontally compromised patients
  • Enrollment on a regular supportive periodontal therapy (SPT) program.
  • Full-mouth plaque score (FMPS)< 25% at baseline;
  • Full-mouth bleeding score (FMBS)< 25% at baseline;
  • Patients having bilateral mesioangular impacted mandibular third molars with the presence of a pocket distally to the mandibular second molar with a probing depth (PD) ≥7 mm
  • Intact buccal and lingual cortical bone of the post-extraction site

Exclusion Criteria:

  • 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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Forebyggelse
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: PRF (platelet-rich fibrin)
PRF will be used after the extraction of the third molar to prevent periodontal defects to second molar
Procedure: extraction of mandibular third molar
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
Aktiv komparator: spontaneous healing
after the extraction of the third molar the socket will be left to heal spontaneously
Procedure: extraction of mandibular third molar
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Clinical attachment level change
Tidsramme: 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.
12 and 18 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
probing depth change
Tidsramme: 12 and 18 weeks
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.
12 and 18 weeks
gingival recession change
Tidsramme: 12 and 18 weeks

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.
12 and 18 weeks

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Naples

Efterforskere

  • Ledende efterforsker: Gilberto Sammartino, Professor, Federico II University

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

7. januar 2018

Primær færdiggørelse (Faktiske)

19. juli 2019

Studieafslutning (Faktiske)

19. juli 2019

Datoer for studieregistrering

Først indsendt

22. juli 2019

Først indsendt, der opfyldte QC-kriterier

25. juli 2019

Først opslået (Faktiske)

26. juli 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

25. marts 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. marts 2020

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 56/15

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Molar, Tredje

Kliniske forsøg med extraction of mandibular third molar

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