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

NCT ID: NCT04452734

Last Updated: 2020-06-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-07-21
• Study Completion Date: 2016-05-14

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.

Conditions

Tooth Extraction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Control Group

Group Type: ACTIVE_COMPARATOR

Surgical Extraction

Intervention Type: PROCEDURE

Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.

Study Group

Group Type: EXPERIMENTAL

Platelet Rich Plasma (PRP)

Intervention Type: PROCEDURE

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

Intervention Type: PROCEDURE

Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.

Interventions

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

Intervention Type: PROCEDURE

Surgical Extraction

Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.

Intervention Type: PROCEDURE

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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• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Foundation University Islamabad

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maidah Hanif, BDS, FCPS

Role: PRINCIPAL_INVESTIGATOR

Foundation University College of Dentistry

Muhammad Azhar Sheikh, BDS, MSc, FFD

Role: STUDY_CHAIR

Foundation University College of Dentistry

References

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.

Reference Type: BACKGROUND

PMID: 21550158 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 21778014 (View on PubMed)

Other Identifiers

FUI/CTR/2020/3

Identifier Type: -

Identifier Source: org_study_id