<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04452734</url>
  </required_header>
  <id_info>
    <org_study_id>FUI/CTR/2020/3</org_study_id>
    <nct_id>NCT04452734</nct_id>
  </id_info>
  <brief_title>Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.</brief_title>
  <official_title>Efficacy of Platelet Rich Plasma (PRP) on Mouth Opening and Pain After Surgical Extraction of Mandibular Third Molars.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Foundation University Islamabad</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Foundation University Islamabad</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Wisdom tooth extraction is the most common surgical procedure being carried out in oral&#xD;
      surgical departments. The complications carried by post operative period include pain and&#xD;
      trismus and may affect patient's quality of life.&#xD;
&#xD;
      PRP is an autologous concentrate of platelet in plasma and accelerate healing by production&#xD;
      of growth factors. PRP is prepared from patient's own blood and later packed with gel sponge&#xD;
      (Spongistone) in the experimental group immediately after surgical extraction of mandibular&#xD;
      third molar teeth, followed by suture placement to close the surgical site.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Wisdom tooth extraction is the most common surgical procedure being carried out in oral&#xD;
      surgical departments. The complications carried by post operative period includes pain,&#xD;
      swelling, trismus , along with disturbance in post extraction wound healing which may&#xD;
      significantly affect patient's quality of life.&#xD;
&#xD;
      PRP is an autologous concentrate of platelet suspended in plasma and accelerate healing by&#xD;
      production of various growth factors. PRP is prepared from patient's own blood and later&#xD;
      packed with gel sponge (Spongistone) in the experimental group immediately after surgical&#xD;
      extraction of mandibular third molar teeth, followed by suture placement to close the&#xD;
      surgical site. PRP speeds up healing by concentration of growth factors which can lessen the&#xD;
      inflammation and decreases trismus and pain.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 21, 2015</start_date>
  <completion_date type="Actual">May 14, 2016</completion_date>
  <primary_completion_date type="Actual">May 14, 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>1 day</time_frame>
    <description>Visual Analogue Scale (VAS) used to quantify pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>3rd post op day</time_frame>
    <description>Visual Analogue Scale (VAS) used to quantify pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Visual Analogue Scale (VAS)</measure>
    <time_frame>7th post op day</time_frame>
    <description>Visual Analogue Scale (VAS) used to quantify pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trismus</measure>
    <time_frame>1 day</time_frame>
    <description>Trismus was quantified/measured using Vernier Calliper.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trismus</measure>
    <time_frame>3rd post op day</time_frame>
    <description>Trismus was quantified/measured using Vernier Calliper.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Trismus</measure>
    <time_frame>7th post op day</time_frame>
    <description>Trismus was quantified/measured using Vernier Calliper.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">130</enrollment>
  <condition>Tooth Extraction</condition>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Study Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Platelet Rich Plasma (PRP)</intervention_name>
    <description>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</description>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Extraction</intervention_name>
    <description>Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.</description>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_label>Study Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age between 18-45 iyears&#xD;
&#xD;
          2. Either gender&#xD;
&#xD;
          3. Patients requiring extraction of mandibular 3rd molars&#xD;
&#xD;
          4. ASA grade1&#xD;
&#xD;
          5. Nonsmokers &amp; non alcoholics&#xD;
&#xD;
          6. Not allergic to any medicines&#xD;
&#xD;
          7. No pain before the extraction procedure&#xD;
&#xD;
          8. No trismus, i.e. normal mouth opening before the extraction procedure -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        a) Systemic diseases b) Compromised immune system c) Platelet count less than 1.5 lacs/cmm&#xD;
        d) Allergy to drugs e) Patients not willing to participate in the study f) Pregnant&#xD;
        females/Lactating mothers g) Presence of pericoronitis, periapical infection or any&#xD;
        associated lesion.&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maidah Hanif, BDS, FCPS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Foundation University College of Dentistry</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Muhammad Azhar Sheikh, BDS, MSc, FFD</last_name>
    <role>Study Chair</role>
    <affiliation>Foundation University College of Dentistry</affiliation>
  </overall_official>
  <reference>
    <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>
    <PMID>21550158</PMID>
  </reference>
  <reference>
    <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.</citation>
    <PMID>21778014</PMID>
  </reference>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>April 6, 2020</study_first_submitted>
  <study_first_submitted_qc>June 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 29, 2020</last_update_submitted>
  <last_update_submitted_qc>June 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04452734
org study id: FUI/CTR/2020/3
nct id: NCT04452734
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual Analogue Scale (VAS)
time frame: 1 day
description: Visual Analogue Scale (VAS) used to quantify pain
measure: Visual Analogue Scale (VAS)
time frame: 3rd post op day
description: Visual Analogue Scale (VAS) used to quantify pain
measure: Visual Analogue Scale (VAS)
time frame: 7th post op day
description: Visual Analogue Scale (VAS) used to quantify pain
measure: Trismus
time frame: 1 day
description: Trismus was quantified/measured using Vernier Calliper.
measure: Trismus
time frame: 3rd post op day
description: Trismus was quantified/measured using Vernier Calliper.
measure: Trismus
time frame: 7th post op day
description: Trismus was quantified/measured using Vernier Calliper.
arm group label: Control Group
arm group type: Active Comparator
arm group label: Study Group
arm group type: Experimental
intervention type: Procedure
intervention name: Platelet Rich Plasma (PRP)
description: 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
arm group label: Study Group
intervention type: Procedure
intervention name: Surgical Extraction
description: Surgical extraction procedure under Local anesthesia on dental chair, followed by spongstone (gel sponge) and suture placement.
arm group label: Control Group
arm group label: Study Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: No
last name: Maidah Hanif, BDS, FCPS
role: Principal Investigator
affiliation: Foundation University College of Dentistry
last name: Muhammad Azhar Sheikh, BDS, MSc, FFD
role: Study Chair
affiliation: Foundation University College of Dentistry
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.
PMID: 21550158
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.
PMID: 21778014
responsible party type: Sponsor
sharing ipd: No