NCT04452734

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jul 2015

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 21, 2015

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 14, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 14, 2016

Completed
3.9 years until next milestone

First Submitted

Initial submission to the registry

April 6, 2020

Completed
3 months until next milestone

First Posted

Study publicly available on registry

June 30, 2020

Completed
Last Updated

June 30, 2020

Status Verified

April 1, 2020

Enrollment Period

10 months

First QC Date

April 6, 2020

Last Update Submit

June 29, 2020

Conditions

Tooth Extraction

Outcome Measures

Primary Outcomes (6)

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) used to quantify pain

    1 day

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) used to quantify pain

    3rd post op day

  • Visual Analogue Scale (VAS)

    Visual Analogue Scale (VAS) used to quantify pain

    7th post op day

  • Trismus

    Trismus was quantified/measured using Vernier Calliper.

    1 day

  • Trismus

    Trismus was quantified/measured using Vernier Calliper.

    3rd post op day

  • Trismus

    Trismus was quantified/measured using Vernier Calliper.

    7th post op day

Study Arms (2)

Control Group

ACTIVE COMPARATOR
Procedure: Surgical Extraction

Study Group

EXPERIMENTAL
Procedure: Platelet Rich Plasma (PRP)Procedure: Surgical Extraction

Interventions

Platelet Rich Plasma (PRP)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

Study Group
Surgical ExtractionPROCEDURE

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

Control GroupStudy Group

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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 -

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

    PMID: 21550158BACKGROUND

  • 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.

    PMID: 21778014BACKGROUND

Study Officials

  • Maidah Hanif, BDS, FCPS

    Foundation University College of Dentistry

    PRINCIPAL INVESTIGATOR

  • Muhammad Azhar Sheikh, BDS, MSc, FFD

    Foundation University College of Dentistry

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 6, 2020

First Posted

June 30, 2020

Study Start

July 21, 2015

Primary Completion

May 14, 2016

Study Completion

May 14, 2016

Last Updated

June 30, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share