Clinical trial NCT04452734: Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
Official title: Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Tooth Extraction
Lead sponsor: Foundation University Islamabad
Sponsor class: OTHER
First posted: 2020-06-30
Enrollment: 130
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

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.

Eligibility criteria: 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.

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Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 1 day
measure: Visual Analogue Scale (VAS)
timeFrame: 3rd post op day
measure: Visual Analogue Scale (VAS)
timeFrame: 7th post op day
measure: Trismus
timeFrame: 1 day
measure: Trismus
timeFrame: 3rd post op day
measure: Trismus
timeFrame: 7th post op day
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Foundation University College of Dentistry
name: Maidah Hanif, BDS, FCPS
role: PRINCIPAL_INVESTIGATOR
affiliation: Foundation University College of Dentistry
name: Muhammad Azhar Sheikh, BDS, MSc, FFD
role: STUDY_CHAIR
References:
citation: 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.
citation: 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.