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Completed

NCT Number: NCT06609967

Effect Of Autologous Platelet Rich Fibrin On Post-Operative Complications And Healing Following The Extraction

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

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Key information

Conditions

Pain, Postoperative Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Post Operative Swelling Postoperative Complications Signs and Symptoms Soft Tissue Healing Spasm Trismus

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Karachi, Sindh, 75400, Pakistan

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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

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.

Primary outcomes

  1. Pain

    Time frame: 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.

  2. Post operative Swelling

    Time frame: 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.

  3. Trismus- Post surgical limitation in mouth opening

    Time frame: 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.

  4. Wound/ extraction socket healing

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Dow University of Health Sciences

Other

Registry information

Official study title

Effect Of Autologous Platelet Rich Fibrin (PRF) On Post-Operative Complications And Healing Following The Extractions Impacted Mandibular Wisdoms

Acronym: PRF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 24, 2024
Registry last updated
Sep 24, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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