Postoperative Complications Clinical Trial
Official title:
The Usefulness of Injectable-Platelet Rich Fibrin in the Lower Third Molar Extraction: a Randomized-controlled Clinical Study.
Verified date | December 2023 |
Source | University of Naples |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 40 |
Est. completion date | December 29, 2023 |
Est. primary completion date | September 4, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - 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 Exclusion Criteria: - 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 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 |
Country | Name | City | State |
---|---|---|---|
Italy | Gilberto Sammartino | Naples |
Lead Sponsor | Collaborator |
---|---|
University of Naples |
Italy,
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 — View Citation
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 — View Citation
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 — View Citation
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. do — View Citation
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 1 — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Wound healing | Landry index including description from a "Very poor" to an "Excellent" wound healing | Measurements will be taken on day 3, 7, 14, 28 days. | |
Primary | 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 | Postoperative pain | Pain was assessed with a visual analogic scale (VAS) from 0 (absence of pain) to 10 (severe pain). | Everyday after surgery until 7th day. |
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