NCT06073535

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2023

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 27, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 4, 2023

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

September 25, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

October 10, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 29, 2023

Completed
Last Updated

December 21, 2023

Status Verified

December 1, 2023

Enrollment Period

6 months

First QC Date

September 25, 2023

Last Update Submit

December 15, 2023

Conditions

Molar, ThirdPostoperative Complications

Keywords

Molar, thirdPostoperative complicationsSwellingPainPlatelet-rich fibrin

Outcome Measures

Primary Outcomes (1)

  • 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.

    Measurements will be taken before surgery, on day 3 and day 7.

Secondary Outcomes (1)

  • Postoperative pain

    Everyday after surgery until 7th day.

Other Outcomes (1)

  • Wound healing

    Measurements will be taken on day 3, 7, 14, 28 days.

Study Arms (2)

i-PRF

EXPERIMENTAL

i-PRF will be used after the extraction of the third molar to reduce postoperative complications (swelling, pain) and wound healing.

Procedure: Extraction of mandibular third molarDevice: i-PRF

Spontaneous healing

ACTIVE COMPARATOR

After the extraction of the lower third molar the socket will be left to heal spontaneously.

Procedure: Extraction of mandibular third molar

Interventions

Extraction of mandibular third molarPROCEDURE

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.

Spontaneous healingi-PRF
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.

i-PRF

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Non-cooperative patients
  • \- Taking more than two doses of prescribed anti-inflammatory/analgesic medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Gilberto Sammartino

Naples, 80131, Italy

Location

Related Publications (5)

  • 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.

    PMID: 29054564RESULT

  • Dohan 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.

    PMID: 19089687RESULT

  • Passaretti 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.

    PMID: 23855408RESULT

  • Dohan 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.

    PMID: 20925082RESULT

  • Farshidfar 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.

    PMID: 35368368RESULT

MeSH Terms

Conditions

Postoperative ComplicationsPain

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and Symptoms

Study Officials

  • Gilberto Sammartino, Professor

    Federico II University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
The investigator will be unaware of their treatment allocation before surgery. One clinician, not involved in patient treatment and not aware of what therapeutic approach, performed clinical measurement of face swelling on the surgery, 3th and 7th days.
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Full Professor

Study Record Dates

First Submitted

September 25, 2023

First Posted

October 10, 2023

Study Start

February 27, 2023

Primary Completion

September 4, 2023

Study Completion

December 29, 2023

Last Updated

December 21, 2023

Record last verified: 2023-12

Data Sharing

IPD Sharing
Will not share

Locations

IT(1)