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

Not Applicable

Completed

• Conditions: Pain, Postoperative; Post Operative Swelling; Trismus; Soft Tissue Healing
• Interventions: Procedure: application of PRF; Procedure: application of conventional surgicel

• Registration Number: NCT06609967
• Lead Sponsor: Dow University of Health Sciences

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

Study Timeline

• Study First Submitted: 2021-08-27
• Study Start: 2021-11-15
• Primary Completion: 2022-06-01
• Study Completion: 2022-08-30
• Status Verified: 2024-09
• Study First Submitted QC: 2024-09-20
• Last Update Submitted: 2024-09-20
• Study First Posted: 2024-09-24
• Last Update Posted: 2024-09-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 (> 5 a day) will be excluded as well.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF group	application of PRF	-
Non-PRF group	application of conventional surgicel	-

Primary Outcome Measures

Name	Time	Method
Pain	7 days	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.
Post operative Swelling	7 days	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.
Trismus- Post surgical limitation in mouth opening	7 days	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.
Wound/ extraction socket healing	7 days	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.

Trial Locations

Locations (1)

Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences; 🇵🇰 Karachi, Sindh, Pakistan