Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.

June 29, 2020 updated by: Foundation University Islamabad

Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period include pain and trismus and may affect patient's quality of life.

PRP is an autologous concentrate of platelet in plasma and accelerate healing by production of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site.

Study Overview

Detailed Description

Wisdom tooth extraction is the most common surgical procedure being carried out in oral surgical departments. The complications carried by post operative period includes pain, swelling, trismus , along with disturbance in post extraction wound healing which may significantly affect patient's quality of life.

PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by production of various growth factors. PRP is prepared from patient's own blood and later packed with gel sponge (Spongistone) in the experimental group immediately after surgical extraction of mandibular third molar teeth, followed by suture placement to close the surgical site. PRP speeds up healing by concentration of growth factors which can lessen the inflammation and decreases trismus and pain.

Study Type

Interventional

Enrollment (Actual)

130

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 43 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age between 18-45 iyears
  2. Either gender
  3. Patients requiring extraction of mandibular 3rd molars
  4. ASA grade1
  5. Nonsmokers & non alcoholics
  6. Not allergic to any medicines
  7. No pain before the extraction procedure
  8. No trismus, i.e. normal mouth opening before the extraction procedure -

Exclusion Criteria:

a) Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant females/Lactating mothers g) Presence of pericoronitis, periapical infection or any associated lesion.

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
Experimental: Study Group
Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
PRP was prepared by withdrawing 8-10 ml of patients own blood (IV from antecubiodal area and collected in a vacuum tube coated with anticoagulant (Na citrate). For activation 1 ml of calcium chloride was added to Platelet Rich Plasma. This layer of approximately 2 ml of PRP was then taken into the residual bone cavity along with gel sponge to stimulate regeneration in wound healing after surgical extraction of mandibular third molar tooth followed by sutures

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analogue Scale (VAS)
Time Frame: 1 day
Visual Analogue Scale (VAS) used to quantify pain
1 day
Visual Analogue Scale (VAS)
Time Frame: 3rd post op day
Visual Analogue Scale (VAS) used to quantify pain
3rd post op day
Visual Analogue Scale (VAS)
Time Frame: 7th post op day
Visual Analogue Scale (VAS) used to quantify pain
7th post op day
Trismus
Time Frame: 1 day
Trismus was quantified/measured using Vernier Calliper.
1 day
Trismus
Time Frame: 3rd post op day
Trismus was quantified/measured using Vernier Calliper.
3rd post op day
Trismus
Time Frame: 7th post op day
Trismus was quantified/measured using Vernier Calliper.
7th post op day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Maidah Hanif, BDS, FCPS, Foundation University College of Dentistry
  • Study Chair: Muhammad Azhar Sheikh, BDS, MSc, FFD, Foundation University College of Dentistry

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 21, 2015

Primary Completion (Actual)

May 14, 2016

Study Completion (Actual)

May 14, 2016

Study Registration Dates

First Submitted

April 6, 2020

First Submitted That Met QC Criteria

June 29, 2020

First Posted (Actual)

June 30, 2020

Study Record Updates

Last Update Posted (Actual)

June 30, 2020

Last Update Submitted That Met QC Criteria

June 29, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • FUI/CTR/2020/3

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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