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

Tooth Extraction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04452734
• Other study ID #: FUI/CTR/2020/3
• Status: Completed
• Phase: N/A
• Start date: July 21, 2015
• Est. completion date: May 14, 2016

Study information

• Verified date: April 2020
• Source: Foundation University Islamabad
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: May 14, 2016
• Est. primary completion date: May 14, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 45 Years

Eligibility

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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Related Conditions & MeSH terms

• Tooth Extraction

Intervention

Procedure:
• Platelet Rich Plasma (PRP)
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
• Surgical Extraction
Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Foundation University Islamabad

References & Publications (2)

Célio-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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) used to quantify pain	1 day
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) used to quantify pain	3rd post op day
Primary	Visual Analogue Scale (VAS)	Visual Analogue Scale (VAS) used to quantify pain	7th post op day
Primary	Trismus	Trismus was quantified/measured using Vernier Calliper.	1 day
Primary	Trismus	Trismus was quantified/measured using Vernier Calliper.	3rd post op day
Primary	Trismus	Trismus was quantified/measured using Vernier Calliper.	7th post op day