xml: <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/NCT06011005</url>
    </required_header>
    <id_info>
      <org_study_id>MBRU IRB-2022-174</org_study_id>
      <nct_id>NCT06011005</nct_id>
    </id_info>
    <brief_title>Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel.</brief_title>
    <official_title>Efficacy of Ethyl Chloride Topical Anesthesia Application on the Pain Perception During Intra-oral Injections in Children in Comparison to Benzocaine Gel- a Single-blinded Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Mohammed Bin Rashid University of Medicine and Health Sciences</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Mohammed Bin Rashid University of Medicine and Health Sciences</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>
        The goal of this single-blinded randomized controlled trial is to compare pain perception&#xD;
        during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical&#xD;
        gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department&#xD;
        at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United&#xD;
        Arab Emirates (UAE).&#xD;
  &#xD;
        The main question[s] it aims to answer are:&#xD;
  &#xD;
        • How effective is the indirect application of EC topical spray anesthesia on pain perception&#xD;
        during intraoral buccal injection in children in comparsion to BC 20%?&#xD;
  &#xD;
        Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of&#xD;
        Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia&#xD;
        infiltration.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected&#xD;
        randomly and applied per the protocol. A single calibrated operator (A.A) using randomly&#xD;
        selected sealed envelopes that have been previously divided equally according to sample size&#xD;
        arms. The selected envelope is then opened by the operator, who applies either the EC or BC&#xD;
        topical anesthesia technique based on the chosen envelop. Followed by maxillary local&#xD;
        analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is&#xD;
        then observed and assessed by the blinded primary investigator (N.A) (to the topical&#xD;
        anesthesia technique) for pain perception during local anesthesia infiltration based on the&#xD;
        Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog&#xD;
        Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below&#xD;
        protocol.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 24, 2023</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>Diagnostic</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Heart rate</measure>
      <time_frame>5-10 minutes</time_frame>
      <description>Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Sound, Eye, Motor (SEM) Index</measure>
      <time_frame>5-10 minutes</time_frame>
      <description>During the insertion of the needle, the operator will evaluate the patient's behavior for pain perception using sound, eye, motor (SEM) scale and visual analog scale (VAS).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Visual Analog Scale (VAS)</measure>
      <time_frame>5-10 minutes</time_frame>
      <description>The VAS scale is a 100-mm long horizontal line labeled &quot;no pain: at one end and &quot;worst pain possible&quot; at the other. After each procedure (EC or BC), the participants are asked to evaluate the degree of pain (primary outcome) they experienced using the Facial Pain Scale below.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Face Pain Scale</measure>
      <time_frame>5-10 minutes</time_frame>
      <description>These faces show how much something can hurt. This face (point to leftmost face] shows no pain. The faces show more and more pain [point to each from left to the right] up to this one [point to rightmost face] - it shows very much pain. Point to the face that shows how much the child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ''0' = 'no pain' and ''10' = 'very much pain. Do not use words like &quot;happy' and ''sad'. This scale is intended to measure how children feel inside, not how their face looks. Brief word instructions: Point to each face using the words to describe the pain intensity. Ask the children to choose a face that best describes their pain and record the appropriate number.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">42</enrollment>
    <condition>Dental Caries in Children</condition>
    <condition>Anesthesia, Local</condition>
    <condition>Injection Site Discomfort</condition>
    <arm_group>
      <arm_group_label>(Group A) Ethyl Chloride (EC)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Topical application for 30 sec.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>(Group B) Benzocaine gel 20% (BC)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>BC 20% Topical gel application for 30 sec and left for 1 minute.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ethyl Chloride spray (group A)</intervention_name>
      <description>Cold test spray</description>
      <arm_group_label>(Group A) Ethyl Chloride (EC)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Benzocaine gel 20% (group B)</intervention_name>
      <description>Topical analgesia</description>
      <arm_group_label>(Group B) Benzocaine gel 20% (BC)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy children (ASA I) aged between 7 - 10 years old.&#xD;
  &#xD;
            -  Needing any maxillary buccal infiltration (anterior, middle, posterior)&#xD;
  &#xD;
            -  Had no prior history of local anesthesia.&#xD;
  &#xD;
            -  Frankl behavior III or IV&#xD;
  &#xD;
            -  Not taking any painkillers, or other drugs that would influence with their pain&#xD;
               perception.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of a medically compromised condition and intellectual disability. § Any&#xD;
               allergy to local anesthesia.&#xD;
  &#xD;
            -  Active pathology at the site of injection.&#xD;
  &#xD;
            -  Prior history of intra-oral injection.&#xD;
  &#xD;
            -  Frankl behavior I or II.&#xD;
  &#xD;
            -  Children/parents not willing to participate in the study. § Needle phobia.&#xD;
  &#xD;
            -  Patients require treatment under conscious sedation.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>7 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Nagah Abdelrahman</last_name>
      <role>Principal Investigator</role>
      <affiliation>Mohammed Bin Rashid University of Medicine and Health Sciences</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Nagah Abdelrahman</last_name>
      <phone>971551225599</phone>
      <email>Nagah.abdelrahman@residents.mbru.ac.ae</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Anas Alsalami</last_name>
      <phone>971508998048</phone>
      <email>anas.alsalami@mbru.ac.ae</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mohammed Bin Rashid University Of Medicine and Health Sciences</name>
        <address>
          <city>Multiple Locations</city>
          <country>United Arab Emirates</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Anas Alsalami</last_name>
        <phone>971508998048</phone>
        <email>anas.alsalami@mbru.ac.ae</email>
      </contact>
      <investigator>
        <last_name>Nagah Abdelrahman</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Arab Emirates</country>
    </location_countries>
    <results_reference>
      <citation>Dasarraju RK, Svsg N. Comparative efficacy of three topical anesthetics on 7-11-year-old children: a randomized clinical study. J Dent Anesth Pain Med. 2020 Feb;20(1):29-37. doi: 10.17245/jdapm.2020.20.1.29. Epub 2020 Feb 28.</citation>
      <PMID>32158957</PMID>
    </results_reference>
    <results_reference>
      <citation>Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.</citation>
      <PMID>34934271</PMID>
    </results_reference>
    <results_reference>
      <citation>Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.</citation>
      <PMID>23295957</PMID>
    </results_reference>
    <results_reference>
      <citation>Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.</citation>
      <PMID>11242725</PMID>
    </results_reference>
    <results_reference>
      <citation>Gill CJ, Orr DL 2nd. A double-blind crossover comparison of topical anesthetics. J Am Dent Assoc. 1979 Feb;98(2):213-4. doi: 10.14219/jada.archive.1979.0476.</citation>
      <PMID>370178</PMID>
    </results_reference>
    <results_reference>
      <citation>Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.</citation>
      <PMID>26379379</PMID>
    </results_reference>
    <results_reference>
      <citation>Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.</citation>
      <PMID>31842771</PMID>
    </results_reference>
    <results_reference>
      <citation>Hersh EV, Houpt MI, Cooper SA, Feldman RS, Wolff MS, Levin LM. Analgesic efficacy and safety of an intraoral lidocaine patch. J Am Dent Assoc. 1996 Nov;127(11):1626-34; quiz 1665-6. doi: 10.14219/jada.archive.1996.0098.</citation>
      <PMID>8952239</PMID>
    </results_reference>
    <results_reference>
      <citation>Amado A, Sood A, Taylor JS. Contact allergy to lidocaine: a report of sixteen cases. Dermatitis. 2007 Dec;18(4):215-20. doi: 10.2310/6620.2007.06059.</citation>
      <PMID>18021602</PMID>
    </results_reference>
    <results_reference>
      <citation>Silver K, Silver J. The place of James Arnott (1797-1883) in the development of local anaesthesia in dentistry. Br Dent J. 2016 Mar 11;220(5):249-52. doi: 10.1038/sj.bdj.2016.179.</citation>
      <PMID>26964600</PMID>
    </results_reference>
    <results_reference>
      <citation>Davoudi A, Rismanchian M, Akhavan A, Nosouhian S, Bajoghli F, Haghighat A, Arbabzadeh F, Samimi P, Fiez A, Shadmehr E, Tabari K, Jahadi S. A brief review on the efficacy of different possible and nonpharmacological techniques in eliminating discomfort of local anesthesia injection during dental procedures. Anesth Essays Res. 2016 Jan-Apr;10(1):13-6. doi: 10.4103/0259-1162.167846.</citation>
      <PMID>26957683</PMID>
    </results_reference>
    <results_reference>
      <citation>Ernst E, Fialka V. Ice freezes pain? A review of the clinical effectiveness of analgesic cold therapy. J Pain Symptom Manage. 1994 Jan;9(1):56-9. doi: 10.1016/0885-3924(94)90150-3.</citation>
      <PMID>8169463</PMID>
    </results_reference>
    <results_reference>
      <citation>Malanga GA, Yan N, Stark J. Mechanisms and efficacy of heat and cold therapies for musculoskeletal injury. Postgrad Med. 2015 Jan;127(1):57-65. doi: 10.1080/00325481.2015.992719. Epub 2014 Dec 15.</citation>
      <PMID>25526231</PMID>
    </results_reference>
    <results_reference>
      <citation>Kosaraju A, Vandewalle KS. A comparison of a refrigerant and a topical anesthetic gel as preinjection anesthetics: a clinical evaluation. J Am Dent Assoc. 2009 Jan;140(1):68-72; quiz 112-3. doi: 10.14219/jada.archive.2009.0020.</citation>
      <PMID>19119169</PMID>
    </results_reference>
    <results_reference>
      <citation>DiMarco AC, Wetmore AO. Clinical Comparison: Fast-Acting and Traditional Topical Dental Anesthetic. Anesth Prog. 2016 Summer;63(2):55-61. doi: 10.2344/0003-3006-63.2.55.</citation>
      <PMID>27269661</PMID>
    </results_reference>
    <results_reference>
      <citation>Ballesteros-Pena S, Fernandez-Aedo I, Vallejo-De la Hoz G; en representacion del Grupo de Trabajo DIASURE. [Ethyl chloride aerosol spray for local anesthesia before arterial puncture: randomized placebo-controlled trial]. Emergencias. 2017 Jun;29(3):161-166. Spanish.</citation>
      <PMID>28825235</PMID>
    </results_reference>
    <results_reference>
      <citation>French JO, Hooker ML, Vause RB, Robinson AL. Dental Anaesthesia in Children: A Comparison of Vinyl Ether and Ethyl Chloride. Br Med J. 1940 Mar 16;1(4132):432-5. doi: 10.1136/bmj.1.4132.432. No abstract available.</citation>
      <PMID>20783002</PMID>
    </results_reference>
    <results_reference>
      <citation>Hori A, Poureslami HR, Parirokh M, Mirzazadeh A, Abbott P. The ability of pulp sensibility tests to evaluate the pulp status in primary teeth. Int J Paediatr Dent. 2011 Nov;21(6):441-5. doi: 10.1111/j.1365-263X.2011.01147.x. Epub 2011 Jun 27.</citation>
      <PMID>21702853</PMID>
    </results_reference>
    <results_reference>
      <citation>Asfour MA, Millar BJ, Smith PB. An assessment of the reliability of pulp testing deciduous teeth. Int J Paediatr Dent. 1996 Sep;6(3):163-6. doi: 10.1111/j.1365-263x.1996.tb00235.x.</citation>
      <PMID>9115971</PMID>
    </results_reference>
    <results_reference>
      <citation>Russell SC, Doyle E. A risk-benefit assessment of topical percutaneous local anaesthetics in children. Drug Saf. 1997 Apr;16(4):279-87. doi: 10.2165/00002018-199716040-00005.</citation>
      <PMID>9113495</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 5, 2023</study_first_submitted>
    <study_first_submitted_qc>August 22, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 25, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 25, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Mohammed Bin Rashid University of Medicine and Health Sciences</investigator_affiliation>
      <investigator_full_name>Nagah ABdelrahman</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Benzocaine</mesh_term>
      <mesh_term>Ethyl Chloride</mesh_term>
    </intervention_browse>
    <study_docs>
      <study_doc>
        <doc_id>MBRU IRB-2022-174</doc_id>
        <doc_type>Study Protocol</doc_type>
        <doc_url>http://www.mbru.ac.ae</doc_url>
      </study_doc>
    </study_docs>
    <provided_document_section>
      <provided_document>
        <document_type>Study Protocol, Statistical Analysis Plan, and Informed Consent Form</document_type>
        <document_has_protocol>Yes</document_has_protocol>
        <document_has_icf>Yes</document_has_icf>
        <document_has_sap>Yes</document_has_sap>
        <document_date>April 25, 2023</document_date>
        <document_url>https://ClinicalTrials.gov/ProvidedDocs/05/NCT06011005/Prot_SAP_ICF_000.pdf</document_url>
      </provided_document>
    </provided_document_section>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06011005
  org study id: MBRU IRB-2022-174
  nct id: NCT06011005
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The goal of this single-blinded randomized controlled trial is to compare pain perception
        during buccal infiltration using indirect EC spray and topical anesthesia and BC 20% topical
        gel, among seven to 10-year-old school children who attended Pediatric Dentistry Department
        at Dubai Dental Hospital (DDH), Mohammed Bin Rashid University (MBRU) in Dubai, the United
        Arab Emirates (UAE).
  
        The main question[s] it aims to answer are:
  
        • How effective is the indirect application of EC topical spray anesthesia on pain perception
        during intraoral buccal injection in children in comparsion to BC 20%?
  
        Researchers will compare efficacy of 20% Benzocaine (BC) gel and indirect application of
        Ethyl Chloride (EC) spray to see if reducing pain perception during local anesthesia
        infiltration.
  Pre-local analgesia topical Benzocaine gel or Ethyl Chloride technique will be selected
        randomly and applied per the protocol. A single calibrated operator (A.A) using randomly
        selected sealed envelopes that have been previously divided equally according to sample size
        arms. The selected envelope is then opened by the operator, who applies either the EC or BC
        topical anesthesia technique based on the chosen envelop. Followed by maxillary local
        analgesia buccal infiltration for a single tooth by a calibrated operator (A.A). The child is
        then observed and assessed by the blinded primary investigator (N.A) (to the topical
        anesthesia technique) for pain perception during local anesthesia infiltration based on the
        Sound, Eye, Motor index used in this study. The child is then asked to rate the Visual Analog
        Scale and Facial Pain Scale. Heart rate of the patient will be recorded as per below
        protocol.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Diagnostic
  masking: Double (Investigator, Outcomes Assessor)
  measure: Heart rate
  time frame: 5-10 minutes
  description: Each participant's heart rate will be recorded immediately before and after the injection using an FDA-approved pulse oximeter.
  measure: Sound, Eye, Motor (SEM) Index
  time frame: 5-10 minutes
  description: During the insertion of the needle, the operator will evaluate the patient's behavior for pain perception using sound, eye, motor (SEM) scale and visual analog scale (VAS).
  measure: Visual Analog Scale (VAS)
  time frame: 5-10 minutes
  description: The VAS scale is a 100-mm long horizontal line labeled "no pain: at one end and "worst pain possible" at the other. After each procedure (EC or BC), the participants are asked to evaluate the degree of pain (primary outcome) they experienced using the Facial Pain Scale below.
  measure: Face Pain Scale
  time frame: 5-10 minutes
  description: These faces show how much something can hurt. This face (point to leftmost face] shows no pain. The faces show more and more pain [point to each from left to the right] up to this one [point to rightmost face] - it shows very much pain. Point to the face that shows how much the child is hurt. Score the chosen face 0, 2, 4, 6, 8, or 10, counting left to right, so ''0' = 'no pain' and ''10' = 'very much pain. Do not use words like "happy' and ''sad'. This scale is intended to measure how children feel inside, not how their face looks. Brief word instructions: Point to each face using the words to describe the pain intensity. Ask the children to choose a face that best describes their pain and record the appropriate number.
  arm group label: (Group A) Ethyl Chloride (EC)
  arm group type: Experimental
  description: Topical application for 30 sec.
  arm group label: (Group B) Benzocaine gel 20% (BC)
  arm group type: Active Comparator
  description: BC 20% Topical gel application for 30 sec and left for 1 minute.
  intervention type: Other
  intervention name: Ethyl Chloride spray (group A)
  description: Cold test spray
  arm group label: (Group A) Ethyl Chloride (EC)
  intervention type: Other
  intervention name: Benzocaine gel 20% (group B)
  description: Topical analgesia
  arm group label: (Group B) Benzocaine gel 20% (BC)
  criteria: 
  gender: All
  minimum age: 7 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Nagah Abdelrahman
  role: Principal Investigator
  affiliation: Mohammed Bin Rashid University of Medicine and Health Sciences
  last name: Nagah Abdelrahman
  phone: 971551225599
  email: Nagah.abdelrahman@residents.mbru.ac.ae
  last name: Anas Alsalami
  phone: 971508998048
  email: anas.alsalami@mbru.ac.ae
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: United Arab Emirates
  citation: Dasarraju RK, Svsg N. Comparative efficacy of three topical anesthetics on 7-11-year-old children: a randomized clinical study. J Dent Anesth Pain Med. 2020 Feb;20(1):29-37. doi: 10.17245/jdapm.2020.20.1.29. Epub 2020 Feb 28.
  PMID: 32158957
  citation: Lakshmanan L, Ravindran V. Efficacy of Cryotherapy Application on the Pain Perception during Intraoral Injection: A Randomized Controlled Trial. Int J Clin Pediatr Dent. 2021 Sep-Oct;14(5):616-620. doi: 10.5005/jp-journals-10005-2032.
  PMID: 34934271
  citation: Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gotzsche PC, Krleza-Jeric K, Hrobjartsson A, Mann H, Dickersin K, Berlin JA, Dore CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D. SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med. 2013 Feb 5;158(3):200-7. doi: 10.7326/0003-4819-158-3-201302050-00583.
  PMID: 23295957
  citation: Kreider KA, Stratmann RG, Milano M, Agostini FG, Munsell M. Reducing children's injection pain: lidocaine patches versus topical benzocaine gel. Pediatr Dent. 2001 Jan-Feb;23(1):19-23.
  PMID: 11242725
  citation: Gill CJ, Orr DL 2nd. A double-blind crossover comparison of topical anesthetics. J Am Dent Assoc. 1979 Feb;98(2):213-4. doi: 10.14219/jada.archive.1979.0476.
  PMID: 370178
  citation: Lathwal G, Pandit IK, Gugnani N, Gupta M. Efficacy of Different Precooling Agents and Topical Anesthetics on the Pain Perception during Intraoral Injection: A Comparative Clinical Study. Int J Clin Pediatr Dent. 2015 May-Aug;8(2):119-22. doi: 10.5005/jp-journals-10005-1296. Epub 2015 Aug 11.
  PMID: 26379379
  citation: Hindocha N, Manhem F, Backryd E, Bagesund M. Ice versus lidocaine 5% gel for topical anaesthesia of oral mucosa - a randomized cross-over study. BMC Anesthesiol. 2019 Dec 16;19(1):227. doi: 10.1186/s12871-019-0902-8.
  PMID: 31842771
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  responsible party type: Principal Investigator
  investigator affiliation: Mohammed Bin Rashid University of Medicine and Health Sciences
  investigator full name: Nagah ABdelrahman
  investigator title: Principal Investigator
  mesh term: Dental Caries
  mesh term: Benzocaine
  mesh term: Ethyl Chloride
  study doc: 
  provided document: 