ClinicalTrials.gg
CompletedNCT06609967PRFUpdated Sep 24, 2024

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

An interventional study of application of PRF and application of conventional surgicel in Pain, Postoperative, Post Operative Swelling and Trismus, sponsored by Dow University of Health Sciences. Completed at 1 site in Pakistan. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-09-24.

Sponsored by Dow University of Health Sciences · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 60 Years
Sex
All
01

Study 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

Read the 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

02

Conditions studied

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

Keywords

  • prf
  • extraction socket
  • post operative complications
  • wisdom tooth extractions
  • surgical extractions
03

In context

Pain, Postoperative

5,640 studies on the registry are indexed under Pain, Postoperative; 1,230 are open to participants now.

This study's enrollment of 30 is below the median of 75 across 4,821 interventional studies indexed under Pain, Postoperative.

Browse Pain, Postoperative studies →

Lead sponsor

Dow University of Health Sciences is the lead sponsor of 179 studies on the registry; 34 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  1. Medically compromised patients.
  2. 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.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • Experimental
    PRF group

    Procedure: application of PRF

  • Active comparator
    Non-PRF group

    Procedure: application of conventional surgicel

Interventions

  • Procedureapplication of PRF

    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

  • Procedureapplication of conventional surgicel

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 7 days

  2. 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.

    Time frame: 7 days

  3. 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.

    Time frame: 7 days

  4. 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.

    Time frame: 7 days

07

Study locations

1 site
  • Department of Oral and Maxillofacial Surgery, Dow University of Health Sciences
    Karachi, Sindh 75400, Pakistan
08

References and documents

Publications

  • 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. PubMed 33386040 ↗

Individual participant data

Plan to share: Undecided — Complete data will be shared after consent.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 24, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06609967
Responsible party
Hamza Jawed (Principal Investigator, Dow University of Health Sciences) — Principal investigator
First posted
Sep 24, 2024
Start date
Nov 15, 2021
Primary completion
Jun 1, 2022
Completion
Aug 30, 2022
Last update
Sep 24, 2024

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Sep 2024. You cannot join it, but the record below documents what was studied.

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