<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/NCT04424875</url>
  </required_header>
  <id_info>
    <org_study_id>Melatonin and 3rd molar</org_study_id>
    <nct_id>NCT04424875</nct_id>
  </id_info>
  <brief_title>The Effect of Melatonin Application Following Removal of Impacted Third Molar</brief_title>
  <official_title>Local Melatonin Application Following Removal of an Impacted Mandibular Third Molar: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fayoum University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fayoum University</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>
      In the present study, the main hypothesis hypothesizes that the local application of&#xD;
      melatonin in the post-extraction socket produces favorable differences in the immediate&#xD;
      postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the&#xD;
      natural healing process of the socket.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">May 1, 2021</completion_date>
  <primary_completion_date type="Actual">March 1, 2021</primary_completion_date>
  <phase>Phase 3</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>Supportive Care</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bone density</measure>
    <time_frame>6months</time_frame>
    <description>The bone density within the extraction socket was measured using software of cone beam</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Osteoprotegerin (OPG)</measure>
    <time_frame>4weeks postoperatively</time_frame>
    <description>Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain sensation</measure>
    <time_frame>7 days postoperative</time_frame>
    <description>a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>swelling</measure>
    <time_frame>7 days postoperative</time_frame>
    <description>a tape measure, from the tragus to the corner of the mouth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>trismus</measure>
    <time_frame>7days postoperative</time_frame>
    <description>measuring the distance between incisal edges of upper and lower central incisor at maximal mouth</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Impacted Third Molar Tooth</condition>
  <arm_group>
    <arm_group_label>study arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controlled arm</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>3 mg melatonin</intervention_name>
    <description>patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%</description>
    <arm_group_label>study arm</arm_group_label>
    <other_name>melatonin group</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%</description>
    <arm_group_label>controlled arm</arm_group_label>
    <other_name>cellulose group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18ys&#xD;
&#xD;
          -  no systemic disease&#xD;
&#xD;
          -  impacted mandibular third molar class II position B on Pell- Gregory classification&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  history of metabolic or systemic diseases affecting bone or healing process,&#xD;
&#xD;
          -  local infection,&#xD;
&#xD;
          -  tobacco use,&#xD;
&#xD;
          -  oral contraceptive,&#xD;
&#xD;
          -  pregnancy and lactation&#xD;
&#xD;
          -  patients who had taken analgesics or anti-inflammatories for 1 week prior to&#xD;
             enrollment in the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.</citation>
    <PMID>25350595</PMID>
  </reference>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 11, 2020</study_first_posted>
  <last_update_submitted>May 16, 2021</last_update_submitted>
  <last_update_submitted_qc>May 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fayoum University</investigator_affiliation>
    <investigator_full_name>Shaimaa Mohsen</investigator_full_name>
    <investigator_title>lecturer,oral surgery</investigator_title>
  </responsible_party>
  <keyword>impacted third molar</keyword>
  <keyword>melatonine</keyword>
  <keyword>bone healing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Melatonin</mesh_term>
  </intervention_browse>
  <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/NCT04424875
org study id: Melatonin and 3rd molar
nct id: NCT04424875
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
In the present study, the main hypothesis hypothesizes that the local application of
      melatonin in the post-extraction socket produces favorable differences in the immediate
      postoperative period, as anti-inflammatory, analgesic, and early osteogenic regarding the
      natural healing process of the socket.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bone density
time frame: 6months
description: The bone density within the extraction socket was measured using software of cone beam
measure: Osteoprotegerin (OPG)
time frame: 4weeks postoperatively
description: Human Osteoprotegerin (OPG) ELISA Kit was used to detect OPG levels.The changes in OPG in the whole group in the predetermined period immediate postoperative , after 4 week,and 6months
measure: pain sensation
time frame: 7 days postoperative
description: a visual analogue scale (VAS) of 10 units in combination with a graphic rating scale. On the VAS, the left most end represented the absence of pain (score 0) and the right most end indicated the most severe pain (score 10).
measure: swelling
time frame: 7 days postoperative
description: a tape measure, from the tragus to the corner of the mouth.
measure: trismus
time frame: 7days postoperative
description: measuring the distance between incisal edges of upper and lower central incisor at maximal mouth
arm group label: study arm
arm group type: Experimental
description: patients will undergo surgery to remove impacted lower third molar and receive Melatonin (3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%) in the socket following removal of the impacted third molar
arm group label: controlled arm
arm group type: Placebo Comparator
description: patients will undergo surgery to remove impacted lower third molar and patients will receive no melatonin (2 ml of hydroxyethyl cellulose gel 2 %).
intervention type: Drug
intervention name: 3 mg melatonin
description: patients will remove impacted third molar and receive 3 mg melatonin into 2 ml hydroxyethyl cellulose gel 2%
arm group label: study arm
other name: melatonin group
intervention type: Drug
intervention name: Placebo
description: patients will remove impacted third molar and receive 2 ml hydroxyethyl cellulose gel 2%
arm group label: controlled arm
other name: cellulose group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Egypt
citation: Cobo-Vazquez C, Fernandez-Tresguerres I, Ortega-Aranegui R, Lopez-Quiles J. Effects of local melatonin application on post-extraction sockets after third molar surgery. A pilot study. Med Oral Patol Oral Cir Bucal. 2014 Nov 1;19(6):e628-33. doi: 10.4317/medoral.19851.
PMID: 25350595
responsible party type: Principal Investigator
investigator affiliation: Fayoum University
investigator full name: Shaimaa Mohsen
investigator title: lecturer,oral surgery
mesh term: Tooth, Impacted
mesh term: Melatonin
sharing ipd: No