Clinical trial NCT06609967: Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction
Official title: Effect of Autologous Platelet Rich Fibrin (PRF) on Post-Operative Complications and Healing Following the Extractions Impacted Mandibular Wisdoms
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Post Operative Swelling
Trismus
Soft Tissue Healing
Keywords: prf
extraction socket
post operative complications
wisdom tooth extractions
surgical extractions
Lead sponsor: Dow University of Health Sciences
Sponsor class: OTHER
First posted: 2024-09-24
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: As post-operative pain, infection inflammation and infections are the main complications after the surgical extraction of the lower third molar the aim of this study is to compare the healing effects of PRF administered postoperatively

Detailed description: PRF will be randomly administered into one group of patients undergoing any extractions group A (Right after the extraction) Group B will be a control group in which extraction sockets will be left to heal with the natural blood clot. Consenting patients will be assigned into groups randomly and not informed which group they were placed into. The PRF will be administered obtained from a tube of 10 ml blood and no material will be placed in the control group. The progress of healing and post-operative complications will be tracked over a period of 7 days with patients being called for follow-up on days 3, 5 and 7. Their post-operative complications will be checked at every subsequent visit and noted in the questionnaire. The Questionnaire is structured and will be interviewer-administered. It will comprise of basic bio-demographic data (such as name, age, sex, etc) and 3 closed-ended questions related to post-operative complications following the extraction

Eligibility criteria: Inclusion Criteria:

1. Both male and female patients
2. Patients that give their consent to the use of their information and to the administration of the drug will be the participants of the study.
3. Patients with 3rd molar impactions
4. Absence of systemic diseases
5. age ⩾18 years and the ability to cooperate with the requirements of the study protocol.

Exclusion Criteria:

1. Medically compromised patients.
2. Immunocompromised patients.
3. Patients that do not consent.
4. Patients that are below the age of 17.
5. Patients that are pregnant.
6. Fully erupted molars will be excluded. smokers (\&amp;gt; 5 a day) will be excluded as well.

Primary outcomes:
measure: Pain
timeFrame: 7 days
measure: Post operative Swelling
timeFrame: 7 days
measure: Trismus- Post surgical limitation in mouth opening
timeFrame: 7 days
measure: Wound/ extraction socket healing
timeFrame: 7 days
Secondary outcomes:
Other outcomes:
Locations:
city: Karachi
country: Pakistan
facility: Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences
state: Sindh
Study officials:
References:
citation: Passarelli PC, Romeo A, Lopez MA, De Angelis P, Desantis V, Piccirillo GB, Papa R, Papi P, Pompa G, Moffa A, Casale M, D'Addona A. Evaluation of the periodontal healing of the second mandibular molar distal site following insertion of PRF in the third molar post extraction alveolus. J Biol Regul Homeost Agents. 2020 Sep-Oct;34(5 Suppl. 3):111-118. Technology in Medicine.