<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/NCT04458142</url>
  </required_header>
  <id_info>
    <org_study_id>14422017496954</org_study_id>
    <nct_id>NCT04458142</nct_id>
  </id_info>
  <brief_title>Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration</brief_title>
  <official_title>Comparison of The Efficiency of Single Buccal Infiltration Versus Buccal and Intrapapillary Infiltration Using 4% Articaine During Extraction of Primary Maxillary Molar Teeth: A Randomized Controlled Trial Split Mouth Design Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      Everyday practice in dentistry is based on giving the painless injection and achieving&#xD;
      adequate local anesthesia. Various techniques of reducing injection pain in children can be&#xD;
      broadly categorized as psychological and physical. The psychological approach includes&#xD;
      behavior management techniques, physical means and other recent techniques such as computer&#xD;
      controlled anesthesia, electronic dental anesthesia, and so forth. However, none of these&#xD;
      techniques have been successful in eliminating pain, fear and anxiety in children.&#xD;
&#xD;
      Direct palatal injection technique is difficult to administer without significant pain or&#xD;
      discomfort since there is little tissue space at these sites between the mucosa and the&#xD;
      underlying periosteum. Studies conducted on indirect palatal injection technique&#xD;
      (intrapapillary) revealed that it reduces the pain of palatal injection with the same&#xD;
      efficacy of anesthesia during extraction.&#xD;
&#xD;
      The desirable method to evade pain during palatal injection is just not to have one.&#xD;
&#xD;
      Maxillary molars removal without palatal or multiple injections is possible due to relatively&#xD;
      thin porous bone of posterior buccal maxilla that facilitates the diffusion of local&#xD;
      anesthetic.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The provision of intraoral palatal anesthesia can be potentially more painful for the patient&#xD;
      when compared to other sites of the oral cavity, as palatal tissues are tightly bound to the&#xD;
      hard palate with limited tissue space between it and the periosteum . As the injection is&#xD;
      given, pressure builds up within the palatal tissues causing pain.&#xD;
&#xD;
      Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it&#xD;
      reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.&#xD;
&#xD;
      The desirable method to evade pain during palatal injection is just not to have one. So&#xD;
      studies was made to evaluate the single buccal injection and its efficiency during extraction&#xD;
      of maxillary teeth. The relatively thin porous bone of posterior buccal maxilla facilitates&#xD;
      the diffusion of local anesthetic,as well as articaine can diffuse through soft and hard&#xD;
      tissues more reliably than other LA so that maxillary buccal infiltration of articaine&#xD;
      provides palatal soft tissue anesthesia.Therefore single injection eliminates the need for&#xD;
      multiple painful injections.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">October 1, 2020</start_date>
  <completion_date type="Anticipated">March 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2021</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Behavior pain assessment during anesthesia and extraction</measure>
    <time_frame>Intraoperative</time_frame>
    <description>FLACC Behavioral Pain Scale will be used for assessment during anaesthesia and extraction. This scale consists of 5 categories face, leg, activity, cry, consolabilty. Each category is scored on the 0-2 scale, which results in a total score of 0-10.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Subjective self report pain assessment after anesthesia and extraction</measure>
    <time_frame>intraoperative</time_frame>
    <description>Second subjective self report assesment will be done using Wong-baker scale after the anaesthsia and extraction.It consist of a set of cartoon faces with varying facial expression ranging from smile/laughter to tears.• Each face has a numerical value ranging from 0-5.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>physiological record of pain after anesthesia and extraction</measure>
    <time_frame>intraoperative</time_frame>
    <description>phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Anesthesia, Local</condition>
  <arm_group>
    <arm_group_label>Single buccal infiltration using 4%articaine</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Dryness the site of injection then application of topical anesthetic gel(2% benzocaine).&#xD;
Injecting by a small amount of solution in the superficial mucosa. After a few seconds, the needle was slowly advanced in the mucobuccal fold toward the apex of the molar and 1.8 ml of 4% articaine using short 30-gauge needle was slowly given.&#xD;
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed by inquiring about the area of numbness from the participant, no pain during pricking the palatal mucosa. The cases in which palatal anesthesia will not be reported by the patient will be given supplemental palatal infiltration with 0.2 to 0.3 mL articaine.&#xD;
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Buccal and intrapapillary infiltration using 4%articaine</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Dryness the site of injection then application of topical anesthetic gel(2% benzocaine) Injecting a small amount of solution in the superficial mucosa,then needle will slowly advanced in the mucobuccal fold toward the apex of the molar and 1.5 ml of 4% articaine was slowly given. The remaining 0.3ml solution will be given equally into the distal, mesial intrapapillary and palatal sites respectively until blanching of the palate is observed extending more than halfway along the palatal gingival margin.&#xD;
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed.&#xD;
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Single buccal infiltration</intervention_name>
    <description>painless technique for palatal anesthesia,single injection,single puncture given</description>
    <arm_group_label>Buccal and intrapapillary infiltration using 4%articaine</arm_group_label>
    <arm_group_label>Single buccal infiltration using 4%articaine</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children from 6 to 9 years of age requiring extraction in two different quadrants in&#xD;
             maxillary arch.&#xD;
&#xD;
               -  Children who demonstrate positive or definitely positive behavior during&#xD;
                  pretreatment evaluation ranking 3 or 4 in the Frankl scale.&#xD;
&#xD;
                    -  Rating 3: Positive Acceptance of treatment; at times cautious; willingness&#xD;
                       to comply with the dentist, at times with reservation, but patient follows&#xD;
                       the dentist's directions cooperatively.&#xD;
&#xD;
                    -  Rating 4 :Definitely positive Good rapport with the dentists interested in&#xD;
                       the dental procedures, laughing and enjoying.&#xD;
&#xD;
               -  Child must give assent prior to participation, as well as parental informed&#xD;
                  written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically and mentally compromised children.&#xD;
&#xD;
          -  Children with a history of prolonged bleeding, platelet disorders, hypersensitivity,&#xD;
&#xD;
          -  History of significant behavior management problems.&#xD;
&#xD;
          -  Patients having active sites of pathosis in the area of injection.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>July 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 1, 2020</last_update_submitted>
  <last_update_submitted_qc>July 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Hadil Ahmed Mohamed Ahmed ELSafty</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>study protocol, informed consent, clinical study report</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>After completion of the study</ipd_time_frame>
    <ipd_access_criteria>ClinicalTrials.gov</ipd_access_criteria>
    <ipd_url>http://ClinicalTrials.gov</ipd_url>
  </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/NCT04458142
org study id: 14422017496954
nct id: NCT04458142
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Everyday practice in dentistry is based on giving the painless injection and achieving
      adequate local anesthesia. Various techniques of reducing injection pain in children can be
      broadly categorized as psychological and physical. The psychological approach includes
      behavior management techniques, physical means and other recent techniques such as computer
      controlled anesthesia, electronic dental anesthesia, and so forth. However, none of these
      techniques have been successful in eliminating pain, fear and anxiety in children.

      Direct palatal injection technique is difficult to administer without significant pain or
      discomfort since there is little tissue space at these sites between the mucosa and the
      underlying periosteum. Studies conducted on indirect palatal injection technique
      (intrapapillary) revealed that it reduces the pain of palatal injection with the same
      efficacy of anesthesia during extraction.

      The desirable method to evade pain during palatal injection is just not to have one.

      Maxillary molars removal without palatal or multiple injections is possible due to relatively
      thin porous bone of posterior buccal maxilla that facilitates the diffusion of local
      anesthetic.
The provision of intraoral palatal anesthesia can be potentially more painful for the patient
      when compared to other sites of the oral cavity, as palatal tissues are tightly bound to the
      hard palate with limited tissue space between it and the periosteum . As the injection is
      given, pressure builds up within the palatal tissues causing pain.

      Studies conducted on indirect palatal injection technique (intrapapillary) revealed that it
      reduces the pain of palatal injection with the same efficacy of anesthesia during extraction.

      The desirable method to evade pain during palatal injection is just not to have one. So
      studies was made to evaluate the single buccal injection and its efficiency during extraction
      of maxillary teeth. The relatively thin porous bone of posterior buccal maxilla facilitates
      the diffusion of local anesthetic,as well as articaine can diffuse through soft and hard
      tissues more reliably than other LA so that maxillary buccal infiltration of articaine
      provides palatal soft tissue anesthesia.Therefore single injection eliminates the need for
      multiple painful injections.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Behavior pain assessment during anesthesia and extraction
time frame: Intraoperative
description: FLACC Behavioral Pain Scale will be used for assessment during anaesthesia and extraction. This scale consists of 5 categories face, leg, activity, cry, consolabilty. Each category is scored on the 0-2 scale, which results in a total score of 0-10.
measure: Subjective self report pain assessment after anesthesia and extraction
time frame: intraoperative
description: Second subjective self report assesment will be done using Wong-baker scale after the anaesthsia and extraction.It consist of a set of cartoon faces with varying facial expression ranging from smile/laughter to tears.• Each face has a numerical value ranging from 0-5.
measure: physiological record of pain after anesthesia and extraction
time frame: intraoperative
description: phisiological record including heart rate and blood pressure using an automatic blood pressure monitor.
arm group label: Single buccal infiltration using 4%articaine
arm group type: Experimental
description: Dryness the site of injection then application of topical anesthetic gel(2% benzocaine).
Injecting by a small amount of solution in the superficial mucosa. After a few seconds, the needle was slowly advanced in the mucobuccal fold toward the apex of the molar and 1.8 ml of 4% articaine using short 30-gauge needle was slowly given.
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed by inquiring about the area of numbness from the participant, no pain during pricking the palatal mucosa. The cases in which palatal anesthesia will not be reported by the patient will be given supplemental palatal infiltration with 0.2 to 0.3 mL articaine.
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.
arm group label: Buccal and intrapapillary infiltration using 4%articaine
arm group type: Active Comparator
description: Dryness the site of injection then application of topical anesthetic gel(2% benzocaine) Injecting a small amount of solution in the superficial mucosa,then needle will slowly advanced in the mucobuccal fold toward the apex of the molar and 1.5 ml of 4% articaine was slowly given. The remaining 0.3ml solution will be given equally into the distal, mesial intrapapillary and palatal sites respectively until blanching of the palate is observed extending more than halfway along the palatal gingival margin.
Subjective assessment of buccal and palatal soft tissue anesthesia will be assessed.
After achieving adequate buccal and palatal tissue anesthesia, the tooth will be extracted under aspetic technique.
intervention type: Other
intervention name: Single buccal infiltration
description: painless technique for palatal anesthesia,single injection,single puncture given
arm group label: Buccal and intrapapillary infiltration using 4%articaine
arm group label: Single buccal infiltration using 4%articaine
criteria: 
gender: All
minimum age: 6 Years
maximum age: 9 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Hadil Ahmed Mohamed Ahmed ELSafty
investigator title: principle investigator
sharing ipd: Yes
ipd description: study protocol, informed consent, clinical study report
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)
ipd time frame: After completion of the study
ipd access criteria: ClinicalTrials.gov
ipd url: http://ClinicalTrials.gov