- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04452734
Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
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
Status
Conditions
Intervention / Treatment
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
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age between 18-45 iyears
- Either gender
- Patients requiring extraction of mandibular 3rd molars
- ASA grade1
- Nonsmokers & non alcoholics
- Not allergic to any medicines
- No pain before the extraction procedure
- 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
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
Sponsor
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
General Publications
- Ogundipe OK, Ugboko VI, Owotade FJ. Can autologous platelet-rich plasma gel enhance healing after surgical extraction of mandibular third molars? J Oral Maxillofac Surg. 2011 Sep;69(9):2305-10. doi: 10.1016/j.joms.2011.02.014. Epub 2011 May 7.
- Celio-Mariano R, de Melo WM, Carneiro-Avelino C. Comparative radiographic evaluation of alveolar bone healing associated with autologous platelet-rich plasma after impacted mandibular third molar surgery. J Oral Maxillofac Surg. 2012 Jan;70(1):19-24. doi: 10.1016/j.joms.2011.03.028. Epub 2011 Jul 20.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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