Effect of Autologous Platelet Rich Fibrin on Post-Operative Complications and Healing Following the Extraction

NCT06609967 | Completed DMC

• 1 other identifier: Hamza001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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

Conditions

Pain, Postoperative; Post Operative Swelling; Trismus; Soft Tissue Healing

Keywords

prf; extraction socket; post operative complications; wisdom tooth extractions; surgical extractions

Outcome Measures

Primary Outcomes (4)

• Pain

  Post-operative pain will be measured using a visual analog scale in both groups i.e. conventional therapy group and PRF group on the 1st, 3rd and 7th post operative day.

  7 days

• Post operative Swelling

  Post operative swelling will be measured in terms of metric calculation (centimeters) in 2 sites i.e: 1. From the tragus of the ear to angle of mouth and 2. From lateral canthus of eye to angle of mandible on the 3rd and 7th post operative day.

  7 days

• Trismus- Post surgical limitation in mouth opening

  Trismus will be measured as the distance in (cm) between the edges of the maxillary and mandibular central incisors post surgically on the 3rd and 7th post operative day.

  7 days

• Wound/ extraction socket healing

  The wound healing of the extraction socket of mandibular wisdom teeth will be assessed according to Landry\'s criteria on the 7th post operative day.

  7 days

Study Arms (2)

PRF group

EXPERIMENTAL

Procedure: application of PRF

Non-PRF group

ACTIVE COMPARATOR

Procedure: application of conventional surgicel

Interventions

application of PRF PROCEDURE

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

PRF group

application of conventional surgicel PROCEDURE

it will be a control group in which extraction sockets will be left to heal with the natural blood clot.

Non-PRF group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Both male and female patients
• 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.
• Patients with 3rd molar impactions
• Absence of systemic diseases
• age ⩾18 years and the ability to cooperate with the requirements of the study protocol.

You may not qualify if:

• Medically compromised patients.
• Immunocompromised patients.
• Patients that do not consent.
• Patients that are below the age of 17.
• Patients that are pregnant.
• Fully erupted molars will be excluded. smokers (\> 5 a day) will be excluded as well.

Sponsors & Collaborators

• Dow University of Health Sciences: lead

Study Sites (1)

Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences

Karachi, Sindh, 75400, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 33386040 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative; Trismus

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Spasm; Neuromuscular Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 24, 2024
• Study Start: November 15, 2021
• Primary Completion: June 1, 2022
• Study Completion: August 30, 2022
• Last Updated: September 24, 2024

Record last verified: 2024-09

Locations

PA (1)