<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/NCT03784638</url>
  </required_header>
  <id_info>
    <org_study_id>KonyaNEU</org_study_id>
    <nct_id>NCT03784638</nct_id>
  </id_info>
  <brief_title>Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery</brief_title>
  <official_title>Comparison of Two Different Flap Designs for Bilateral Impacted Mandibular Third Molar Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Konya Necmettin Erbakan Üniversitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Konya Necmettin Erbakan Üniversitesi</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study was to compare the effects of lingually-based triangle flap design and&#xD;
      buccally based triangular flap design on postoperative swelling, trismus pain after&#xD;
      mandibular third molar surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Investigators planned a prospective and split mouth study. Thirty patients is randomly&#xD;
      selected. Inclusion criteria is being older than 18 of age, having asymptomatic bilateral&#xD;
      mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully&#xD;
      covered with mucosa and bone, and being otherwise medically healthy. Exclusion criteria is as&#xD;
      follows: Alcohol abuse, smoking, pregnancy and acute severe periodontitis.&#xD;
&#xD;
      All surgeries will be carried out by the same surgeon. For each patient, the impacted teeth&#xD;
      will be extracted in two sessions using the two different flap design.One side of the&#xD;
      patients was selected and labeled as &quot;experimental group&quot;. In this group, investigators will&#xD;
      use lingually-based triangle flap design while investigators extract the impacted third molar&#xD;
      teeth. Other side was accepted as &quot;control group&quot; and in this group, investigators will use&#xD;
      buccally based triangular flap design.&#xD;
&#xD;
      In the experimental group, an incision was made adjacent to the distal surface of the&#xD;
      mandibular second molar, and extended along the sulcus to the distobuccal corner of the&#xD;
      mandibular second molar. An oblique vestibular incision was made and extended into the&#xD;
      vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It&#xD;
      was continued posterosuperiorly towards the anterior border of mandibular ramus. In the&#xD;
      control group, an incision will be made from the anterior border of the mandibular second&#xD;
      molar. It will be extended along the sulcus to the distobuccal corner of the second molar&#xD;
      crown. The incision will be continuous with vertical incision.&#xD;
&#xD;
      A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under&#xD;
      irrigation for removing the third molar.Primary wound closure was accomplished using 4-0 silk&#xD;
      sutures. The patients will be invited after one week for removing the sutures.&#xD;
&#xD;
      After the surgery, the patients will be prescribed a 5-day course of 100 mg flurbiprofen&#xD;
      twice daily, 1 gr amoxicillin twice daily and chlorhexidine gluconate- benzydamine&#xD;
      hydrochloride antiseptic mouthwash every 8 h.There will be at least one month between two&#xD;
      surgeries.&#xD;
&#xD;
      The duration of each procedure from the start of the incision to the time of last suture&#xD;
      placement will be noted.&#xD;
&#xD;
      Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth&#xD;
      opening, wound dehiscence. For the assesment of the pain, pain scale will be used. For the&#xD;
      swelling evaluation, measurement will be done from the different three region on the face.&#xD;
&#xD;
        -  Tragus-Pogonion&#xD;
&#xD;
        -  Tragus-Labial Commissura&#xD;
&#xD;
        -  Angulus Mandible-Lateral canthus&#xD;
&#xD;
      Maximum mouth opening will be noted before and after (one week later) the surgery.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 30, 2018</start_date>
  <completion_date type="Actual">April 3, 2019</completion_date>
  <primary_completion_date type="Actual">March 11, 2019</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>
    <intervention_model_description>lingually-based triangle flap design buccaly-based triangular flap design</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery.</measure>
    <time_frame>Up to 2 weeks</time_frame>
    <description>The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>For the assesment of the pain, pain scale will be used.</measure>
    <time_frame>Up to 1 week</time_frame>
    <description>The patients will fill the pain scale every day until the seventh day after operation.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Impacted Third Molar Tooth</condition>
  <arm_group>
    <arm_group_label>lingually-based triangle flap design</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental group, an incision will be made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision will made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. The lingually-based triangle flap design will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>buccally based triangle flap design</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision. The buccally based triangle flap design will be used.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>lingually-based triangle flap design</intervention_name>
    <description>A mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.</description>
    <arm_group_label>lingually-based triangle flap design</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>buccally based triangular flap design</intervention_name>
    <description>A mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.</description>
    <arm_group_label>buccally based triangle flap design</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  symmetrically positioned impacted bilateral mandibular third molars (mesioangular)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pericoronal pathology&#xD;
&#xD;
          -  use of medications&#xD;
&#xD;
          -  poor oral hygiene&#xD;
&#xD;
          -  smoking habit&#xD;
&#xD;
          -  pregnancy or lactation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dilek Menziletoglu, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Necmettin Erbakan University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Necmettin Erbakan University, Faculty of Dentistry</name>
      <address>
        <city>Konya</city>
        <state>Karatay</state>
        <zip>42050</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>December 14, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 24, 2018</study_first_posted>
  <last_update_submitted>April 4, 2019</last_update_submitted>
  <last_update_submitted_qc>April 4, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">April 8, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Konya Necmettin Erbakan Üniversitesi</investigator_affiliation>
    <investigator_full_name>Dilek Menziletoglu</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>trismus</keyword>
  <keyword>pain</keyword>
  <keyword>edema</keyword>
  <keyword>flap design</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tooth, Impacted</mesh_term>
  </condition_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/NCT03784638
org study id: KonyaNEU
nct id: NCT03784638
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to compare the effects of lingually-based triangle flap design and
      buccally based triangular flap design on postoperative swelling, trismus pain after
      mandibular third molar surgery.
Investigators planned a prospective and split mouth study. Thirty patients is randomly
      selected. Inclusion criteria is being older than 18 of age, having asymptomatic bilateral
      mesioangular impacted mandibular third molar (Pell and Gregory class II, position B) fully
      covered with mucosa and bone, and being otherwise medically healthy. Exclusion criteria is as
      follows: Alcohol abuse, smoking, pregnancy and acute severe periodontitis.

      All surgeries will be carried out by the same surgeon. For each patient, the impacted teeth
      will be extracted in two sessions using the two different flap design.One side of the
      patients was selected and labeled as "experimental group". In this group, investigators will
      use lingually-based triangle flap design while investigators extract the impacted third molar
      teeth. Other side was accepted as "control group" and in this group, investigators will use
      buccally based triangular flap design.

      In the experimental group, an incision was made adjacent to the distal surface of the
      mandibular second molar, and extended along the sulcus to the distobuccal corner of the
      mandibular second molar. An oblique vestibular incision was made and extended into the
      vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It
      was continued posterosuperiorly towards the anterior border of mandibular ramus. In the
      control group, an incision will be made from the anterior border of the mandibular second
      molar. It will be extended along the sulcus to the distobuccal corner of the second molar
      crown. The incision will be continuous with vertical incision.

      A mucoperiosteal flap will be raised, a conventional rotary handpiece will be used under
      irrigation for removing the third molar.Primary wound closure was accomplished using 4-0 silk
      sutures. The patients will be invited after one week for removing the sutures.

      After the surgery, the patients will be prescribed a 5-day course of 100 mg flurbiprofen
      twice daily, 1 gr amoxicillin twice daily and chlorhexidine gluconate- benzydamine
      hydrochloride antiseptic mouthwash every 8 h.There will be at least one month between two
      surgeries.

      The duration of each procedure from the start of the incision to the time of last suture
      placement will be noted.

      Patients are recalled on days 2, 7, 14 postoperative pain, facial swelling, maximum mouth
      opening, wound dehiscence. For the assesment of the pain, pain scale will be used. For the
      swelling evaluation, measurement will be done from the different three region on the face.

        -  Tragus-Pogonion

        -  Tragus-Labial Commissura

        -  Angulus Mandible-Lateral canthus

      Maximum mouth opening will be noted before and after (one week later) the surgery.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: lingually-based triangle flap design buccaly-based triangular flap design
primary purpose: Treatment
masking: None (Open Label)
measure: For edema, the distances between Tragus-Pogonion, Tragus-Labial Commissure, Angulus Mandibula-Lateral Canthus will be measured preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
time frame: Up to 2 weeks
description: The edema measurement will be done preoperatively, postoperative 2nd day, 7th day and 14th day surgery.
measure: For the assesment of the pain, pain scale will be used.
time frame: Up to 1 week
description: The patients will fill the pain scale every day until the seventh day after operation.
arm group label: lingually-based triangle flap design
arm group type: Experimental
description: In the experimental group, an incision will be made adjacent to the distal surface of the mandibular second molar, and extended along the sulcus to the distobuccal corner of the mandibular second molar. An oblique vestibular incision will made and extended into the vestibular fornix of the mandible, aligned with the mesiobuccal cusp of the second molar. It was continued posterosuperiorly towards the anterior border of mandibular ramus. The lingually-based triangle flap design will be used.
arm group label: buccally based triangle flap design
arm group type: Placebo Comparator
description: In the control group, an incision will be made from the anterior border of the mandibular second molar. It will be extended along the sulcus to the distobuccal corner of the second molar crown. The incision will be continuous with vertical incision. The buccally based triangle flap design will be used.
intervention type: Procedure
intervention name: lingually-based triangle flap design
description: A mucoperiosteal lingually-based triangle flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
arm group label: lingually-based triangle flap design
intervention type: Other
intervention name: buccally based triangular flap design
description: A mucoperiosteal buccally based triangular flap will be raised, a conventional rotary handpiece will be used under irrigation for removing the third molar.Primary wound closure will be accomplished using 4-0 silk sutures. The patients will be invited after one week for removing the sutures.
arm group label: buccally based triangle flap design
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dilek Menziletoglu, DDS, PhD
role: Principal Investigator
affiliation: Necmettin Erbakan University
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Konya Necmettin Erbakan Üniversitesi
investigator full name: Dilek Menziletoglu
investigator title: Principal Investigator
mesh term: Tooth, Impacted
sharing ipd: No