<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/NCT03779659</url>
  </required_header>
  <id_info>
    <org_study_id>H-37546</org_study_id>
    <nct_id>NCT03779659</nct_id>
  </id_info>
  <brief_title>Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) During Dental Procedures Among Children</brief_title>
  <official_title>Effectiveness of Synapse Transcutaneous Electronic Nerve Stimulation (TENS) Device in Reducing Pain Among Children 6-14 Years During Dental Treatments in a Randomized Cross-over Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Dental Fear and Anxiety (DFA) are at higher levels among children and often leads to&#xD;
      avoidance of dental treatment. Negative experiences in the early years such as experience of&#xD;
      pain during injections, fillings, or extractions may lead to difficulties in treatment and&#xD;
      behavior management among children. During dental procedures such as restorations and&#xD;
      extractions injectable anesthetics are required as they are used to anesthetize and numb the&#xD;
      area around the tooth receiving treatment. Topical anesthetics are used prior to using&#xD;
      injectable anesthetic to alleviate some pain and discomfort. Topical anesthetics should be&#xD;
      used with caution as they consist of more concentrated doses of pharmaceutical elements used&#xD;
      in injectable anesthetics. Such high concentrations can result in increased gag reflux,&#xD;
      central nervous system depression and cardiovascular effects in rare cases. With many recent&#xD;
      advances in dental treatment, there is also a need for new non-pharmaceutical strategies to&#xD;
      alleviate pain and discomfort among children which in turn will motivate children and their&#xD;
      parents to visit the dental clinic more frequently. Electronic anesthesia or Synapse&#xD;
      Transcutaneous Electronic Nerve Stimulation (TENS), a non-invasive device that uses low&#xD;
      energy electrical stimulation to reduce pain perception, has gained acceptance since the&#xD;
      1990s. Advantages of using the TENS device are that it is safe, easy to use, well-accepted&#xD;
      among patients as evidenced in the few trials conducted so far, no adverse complications and&#xD;
      has been successful in alleviating pain during dental procedures. This study aims to explore&#xD;
      use of the TENS to alleviate pain and discomfort at the oral mucosal site where the patient&#xD;
      will receive a local anesthetic injection. In this randomized case-crossover trial among&#xD;
      children aged 6-14 years the effectiveness of Aleve TENS device in reducing pain and anxiety&#xD;
      among children prior to receiving injectable local anesthetic agent during dental procedures&#xD;
      is compared to those who receive the local anesthetic gel prior to receiving local anesthetic&#xD;
      injection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Children between 6-14 years will be recruited at the Pediatric Oral Healthcare Center. A&#xD;
      sample of 100 male and female children who fit the inclusion and exclusion criteria are&#xD;
      recruited. Once parents' consent at the first visit basic demographic information, dental and&#xD;
      medical history information is collected. This study is conducted in total of two clinic&#xD;
      visits. In the first visit participants are randomized to either the intervention group or&#xD;
      the comparison group. The intervention group receives the experimental device (TENS) prior to&#xD;
      local anesthetic injection whereas the comparison group receives the local anesthetic gel.&#xD;
      Following this the participants receive the local anesthetic injection after which treatment&#xD;
      is completed. In the second visit the participants are crossed over to the other group and&#xD;
      therefore randomization is not used for visit 2. Those who received the local anesthetic gel&#xD;
      in visit 1 will receive the experimental device in visit 2 and those who received the&#xD;
      experimental device in visit 1 will receive the local anesthetic gel in visit 2 . Following&#xD;
      this treatment procedures are completed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    Prior to IRB submission, Covid-19 related logistical and personnel issues led to the decision&#xD;
    to not move forward with this research.&#xD;
  </why_stopped>
  <start_date type="Anticipated">July 2021</start_date>
  <completion_date type="Anticipated">February 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2022</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Presence of Pain before treatment</measure>
    <time_frame>before the start of each treatment procedure up to 6 months</time_frame>
    <description>The presence of pain will be a simple question in the case report form with two answer choices: yes or no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Pain before local analgesic injection</measure>
    <time_frame>after TENS or gel administration before local analgesic injection at about 1 minute</time_frame>
    <description>The presence of pain will be a simple question in the case report form with two answer choices: yes or no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Presence of Pain after treatment</measure>
    <time_frame>about 45 minutes at the end of the treatment visit</time_frame>
    <description>The presence of pain will be a simple question in the case report form with two answer choices: yes or no.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale</measure>
    <time_frame>before the start of each treatment procedure up to 6 months</time_frame>
    <description>Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale</measure>
    <time_frame>after TENS or gel administration before local analgesic injection at about 1 minute</time_frame>
    <description>Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale</measure>
    <time_frame>about 45 minutes at the end of the treatment visit</time_frame>
    <description>Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of dental anxiety before treatment using Visual Analog Scale</measure>
    <time_frame>before the start of each treatment procedure up to 6 months</time_frame>
    <description>Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of dental anxiety before local analgesic injection using Visual Analog Scale</measure>
    <time_frame>after TENS or gel administration before local analgesic injection at about 1 minute</time_frame>
    <description>Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Level of dental anxiety after treatment using Visual Analog Scale</measure>
    <time_frame>about 45 minutes at the end of the treatment visit</time_frame>
    <description>Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Patient's comfort level preference</measure>
    <time_frame>up to 6 months</time_frame>
    <description>The comfort or preference level for TENS device versus local anesthetic gel prior to local anesthetic injection will be assessed by asking the participants about their preference using a question in the case report form with five answer choices (using Likert scale - Very uncomfortable, somewhat uncomfortable, neither comfortable nor uncomfortable, somewhat comfortable, very comfortable)..</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Treatment completion status</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Treatment completion status will be recorded as 'completed' or 'partially completed' on the Case Report Form at the conclusion of each treatment visit.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Reason for partially completed treatment</measure>
    <time_frame>up to 6 months</time_frame>
    <description>For participants that do not complete both treatment procedures and are categorized as 'incomplete', the reason/s why will be documented.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Supplemental anesthetic use</measure>
    <time_frame>up to 6 months</time_frame>
    <description>Amount of supplemental anesthesia if used for each of the two treatment procedures will be recorded in clinic notes after each treatment procedure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Dental Fear</condition>
  <condition>Anesthesia, Local</condition>
  <condition>Pediatric Dentistry</condition>
  <arm_group>
    <arm_group_label>Synapse TENS device</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SYnapse TENS device will be used for alleviating pain through electrical stimulation. This is a battery powered device where an electrical current is applied intra-orally on the buccal and lingual sides using an intra-oral pad applicator. This device has been cleared for marketing by the Food and Drug Administration (FDA) and the prescribed electrical field falls almost a 10 factor level lower than routine pulp testing devices used in dentistry. The TENS device was previously tested in a pilot study with promising results. Chair side application and at-home use of the device by the patient was shown to drastically reduce pain and discomfort associated with orthodontic tooth movement.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Topical anesthetic gel</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical anesthetic Gel is the active comparator in this study. The topical anesthesia (anesthetic gel) Centrix LolliCaine with 20% benzocaine in single package of 0.3 ml will be used. The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure. This will be done based American Association of Pediatric Dentistry guidelines for the use of local anesthesia.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Synapse TENS device</intervention_name>
    <description>At the time of local anesthetic application the TENS device will be activated and placed on the buccal and lingual alveolar mucosa adjacent to the tooth receiving the restorative treatment using the pad applicator. The tip of the device with the electrodes are placed in a vertical up and down motion for approximately ten seconds. Following this, the level of pain and anxiety are measured using the Wong Baker Scale and Visual Analog Scale. The TENS device is used for achieving localized pain relief at the site of local anesthetic injection prior to injecting the anesthetic agent (such as lidocaine or articaine). Following this, once the clinician ensures that the patient is pain free then local anesthetic injection is given and following that the dental procedures are conducted.</description>
    <arm_group_label>Synapse TENS device</arm_group_label>
    <other_name>ALEVE therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical anesthetic gel</intervention_name>
    <description>The local anesthetic gel is typically used for achieving localized pain relief at the site of local anesthetic injection and this is part of standard care that is followed prior to dental procedures.&#xD;
The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure</description>
    <arm_group_label>Topical anesthetic gel</arm_group_label>
    <other_name>Centrix LolliCaine 2% xylocaine with 20% benzocaine</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children who are healthy and without any major medical conditions&#xD;
&#xD;
          -  Children who are patients at the Pediatric Oral Healthcare Center&#xD;
&#xD;
          -  Children requiring restoration on the occlusal surface that involves tooth preparation&#xD;
             up to the dentin level in at least two primary or permanent molars or children&#xD;
             requiring extractions of primary or permanent molars.&#xD;
&#xD;
          -  Children who are scheduled for at least two appointments and who require two&#xD;
             restorative procedures or two extractions than can be scheduled over two separate&#xD;
             appointments&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Children who have contraindications to local anesthetic&#xD;
&#xD;
          -  Children with teeth requiring restoration and have pulp involvement and root&#xD;
             resorption on radiological examination (i.e. deep caries)&#xD;
&#xD;
          -  Children who have major medical problems&#xD;
&#xD;
          -  Children taking medications for major medical illnesses&#xD;
&#xD;
          -  Children who have pacemakers&#xD;
&#xD;
          -  Children with ADD/ADHD, autism or Down's syndrome and children with a history of&#xD;
             behavioral issues that required previous management.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>14 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Jayapriyaa Shanmugham, BDS DrPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>BU Henry M. Goldman School of Dental Medicine</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 4th ed. Washington DC, American Psychiatric Press. 1994.</citation>
  </reference>
  <reference>
    <citation>Alvesalo I, Murtomaa H, Milgrom P, Honkanen A, Karjalainen M, Tay KM. The Dental Fear Survey Schedule: a study with Finnish children. Int J Paediatr Dent. 1993 Dec;3(4):193-8. doi: 10.1111/j.1365-263x.1993.tb00083.x.</citation>
    <PMID>8142322</PMID>
  </reference>
  <reference>
    <citation>Shim YS, Kim AH, Jeon EY, An SY. Dental fear &amp; anxiety and dental pain in children and adolescents; a systemic review. J Dent Anesth Pain Med. 2015 Jun;15(2):53-61. doi: 10.17245/jdapm.2015.15.2.53. Epub 2015 Jun 30.</citation>
    <PMID>28879259</PMID>
  </reference>
  <reference>
    <citation>Cianetti S, Lombardo G, Lupatelli E, Pagano S, Abraha I, Montedori A, Caruso S, Gatto R, De Giorgio S, Salvato R. Dental fear/anxiety among children and adolescents. A systematic review. Eur J Paediatr Dent. 2017 Jun;18(2):121-130. doi: 10.23804/ejpd.2017.18.02.07.</citation>
    <PMID>28598183</PMID>
  </reference>
  <reference>
    <citation>Ogle OE, Mahjoubi G. Local anesthesia: agents, techniques, and complications. Dent Clin North Am. 2012 Jan;56(1):133-48, ix. doi: 10.1016/j.cden.2011.08.003.</citation>
    <PMID>22117947</PMID>
  </reference>
  <reference>
    <citation>Armfield JM, Milgrom P. A clinician guide to patients afraid of dental injections and numbness. SAAD Dig. 2011 Jan;27:33-9.</citation>
    <PMID>21323034</PMID>
  </reference>
  <reference>
    <citation>Lee HS. Recent advances in topical anesthesia. J Dent Anesth Pain Med. 2016 Dec;16(4):237-244. doi: 10.17245/jdapm.2016.16.4.237. Epub 2016 Dec 31.</citation>
    <PMID>28879311</PMID>
  </reference>
  <reference>
    <citation>Boyce RA, Kirpalani T, Mohan N. Updates of Topical and Local Anesthesia Agents. Dent Clin North Am. 2016 Apr;60(2):445-71. doi: 10.1016/j.cden.2015.12.001. Erratum In: Dent Clin North Am. 2017 Apr;61(2):xiii.</citation>
    <PMID>27040295</PMID>
  </reference>
  <reference>
    <citation>Yap AU, Ho HC. Electronic and local anesthesia: a clinical comparison for operative procedures. Quintessence Int. 1996 Aug;27(8):549-53.</citation>
    <PMID>9161258</PMID>
  </reference>
  <reference>
    <citation>Abdulhameed SM, Feigal RJ, Rudney JD, Kajander KC. Effect of peripheral electrical stimulation on measures of tooth pain threshold and oral soft tissue comfort in children. Anesth Prog. 1989 Mar-Apr;36(2):52-7.</citation>
    <PMID>2604057</PMID>
  </reference>
  <reference>
    <citation>teDuits E, Goepferd S, Donly K, Pinkham J, Jakobsen J. The effectiveness of electronic dental anesthesia in children. Pediatr Dent. 1993 May-Jun;15(3):191-6.</citation>
    <PMID>8378157</PMID>
  </reference>
  <reference>
    <citation>Cho SY, Drummond BK, Anderson MH, Williams S. Effectiveness of electronic dental anesthesia for restorative care in children. Pediatr Dent. 1998 Mar-Apr;20(2):105-11.</citation>
    <PMID>9566014</PMID>
  </reference>
  <reference>
    <citation>Baghdadi ZD. Evaluation of electronic dental anesthesia in children. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 1999 Oct;88(4):418-23. doi: 10.1016/s1079-2104(99)70055-7.</citation>
    <PMID>10519748</PMID>
  </reference>
  <reference>
    <citation>Oztas N, Olmez A, Yel B. Clinical evaluation of transcutaneous electronic nerve stimulation for pain control during tooth preparation. Quintessence Int. 1997 Sep;28(9):603-8.</citation>
    <PMID>9477875</PMID>
  </reference>
  <reference>
    <citation>Dhindsa A, Pandit IK, Srivastava N, Gugnani N. Comparative evaluation of the effectiveness of electronic dental anesthesia with 2% lignocaine in various minor pediatric dental procedures: A clinical study. Contemp Clin Dent. 2011 Jan;2(1):27-30. doi: 10.4103/0976-237X.79305.</citation>
    <PMID>22114450</PMID>
  </reference>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 13, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>June 3, 2021</last_update_submitted>
  <last_update_submitted_qc>June 3, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 8, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Electronic dental anesthesia</keyword>
  <keyword>Transcutaneous Electronic Nerve Stimulation (TENS)</keyword>
  <keyword>Topical anesthesia</keyword>
  <keyword>Analgesia</keyword>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
    <mesh_term>Benzocaine</mesh_term>
    <mesh_term>Anesthetics, Local</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Overall findings and summary of results for primary and secondary outcome measures will be made available.</ipd_description>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Once data collection is complete and data analysis has been completed the results will be made available.</ipd_time_frame>
    <ipd_access_criteria>Since this is a pilot study only summary data will be provided.</ipd_access_criteria>
  </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/NCT03779659
org study id: H-37546
nct id: NCT03779659
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
Dental Fear and Anxiety (DFA) are at higher levels among children and often leads to
      avoidance of dental treatment. Negative experiences in the early years such as experience of
      pain during injections, fillings, or extractions may lead to difficulties in treatment and
      behavior management among children. During dental procedures such as restorations and
      extractions injectable anesthetics are required as they are used to anesthetize and numb the
      area around the tooth receiving treatment. Topical anesthetics are used prior to using
      injectable anesthetic to alleviate some pain and discomfort. Topical anesthetics should be
      used with caution as they consist of more concentrated doses of pharmaceutical elements used
      in injectable anesthetics. Such high concentrations can result in increased gag reflux,
      central nervous system depression and cardiovascular effects in rare cases. With many recent
      advances in dental treatment, there is also a need for new non-pharmaceutical strategies to
      alleviate pain and discomfort among children which in turn will motivate children and their
      parents to visit the dental clinic more frequently. Electronic anesthesia or Synapse
      Transcutaneous Electronic Nerve Stimulation (TENS), a non-invasive device that uses low
      energy electrical stimulation to reduce pain perception, has gained acceptance since the
      1990s. Advantages of using the TENS device are that it is safe, easy to use, well-accepted
      among patients as evidenced in the few trials conducted so far, no adverse complications and
      has been successful in alleviating pain during dental procedures. This study aims to explore
      use of the TENS to alleviate pain and discomfort at the oral mucosal site where the patient
      will receive a local anesthetic injection. In this randomized case-crossover trial among
      children aged 6-14 years the effectiveness of Aleve TENS device in reducing pain and anxiety
      among children prior to receiving injectable local anesthetic agent during dental procedures
      is compared to those who receive the local anesthetic gel prior to receiving local anesthetic
      injection.
Children between 6-14 years will be recruited at the Pediatric Oral Healthcare Center. A
      sample of 100 male and female children who fit the inclusion and exclusion criteria are
      recruited. Once parents' consent at the first visit basic demographic information, dental and
      medical history information is collected. This study is conducted in total of two clinic
      visits. In the first visit participants are randomized to either the intervention group or
      the comparison group. The intervention group receives the experimental device (TENS) prior to
      local anesthetic injection whereas the comparison group receives the local anesthetic gel.
      Following this the participants receive the local anesthetic injection after which treatment
      is completed. In the second visit the participants are crossed over to the other group and
      therefore randomization is not used for visit 2. Those who received the local anesthetic gel
      in visit 1 will receive the experimental device in visit 2 and those who received the
      experimental device in visit 1 will receive the local anesthetic gel in visit 2 . Following
      this treatment procedures are completed.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Presence of Pain before treatment
time frame: before the start of each treatment procedure up to 6 months
description: The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
measure: Presence of Pain before local analgesic injection
time frame: after TENS or gel administration before local analgesic injection at about 1 minute
description: The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
measure: Presence of Pain after treatment
time frame: about 45 minutes at the end of the treatment visit
description: The presence of pain will be a simple question in the case report form with two answer choices: yes or no.
measure: Level of pain before treatment based on Wong-Baker Faces (WBF) pain rating scale
time frame: before the start of each treatment procedure up to 6 months
description: Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.
measure: Level of pain before local analgesic injection based on Wong-Baker Faces (WBF) pain rating scale
time frame: after TENS or gel administration before local analgesic injection at about 1 minute
description: Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.
measure: Level of pain after treatment based on Wong-Baker Faces (WBF) pain rating scale
time frame: about 45 minutes at the end of the treatment visit
description: Level of pain will be measured using the Wong-Baker Faces (WBF) pain rating scale. The scale is a set of six cartoon faces with varying facial expressions ranging from a smile/laughter to tears. Each face has a numeric value from 0 to 5, with higher values indicating more pain. Based on child's selection of the facial expression a score will be assigned.
measure: Level of dental anxiety before treatment using Visual Analog Scale
time frame: before the start of each treatment procedure up to 6 months
description: Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.
measure: Level of dental anxiety before local analgesic injection using Visual Analog Scale
time frame: after TENS or gel administration before local analgesic injection at about 1 minute
description: Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.
measure: Level of dental anxiety after treatment using Visual Analog Scale
time frame: about 45 minutes at the end of the treatment visit
description: Level of anxiety will be measured using the Visual Analog Scale. The scale is a simple line with the number line ranging from 0 to 10. Children are asked how nervous or confident they feel and are asked to point or mark on the line. The corresponding numerical value will be noted for each patient.
measure: Patient's comfort level preference
time frame: up to 6 months
description: The comfort or preference level for TENS device versus local anesthetic gel prior to local anesthetic injection will be assessed by asking the participants about their preference using a question in the case report form with five answer choices (using Likert scale - Very uncomfortable, somewhat uncomfortable, neither comfortable nor uncomfortable, somewhat comfortable, very comfortable)..
measure: Treatment completion status
time frame: up to 6 months
description: Treatment completion status will be recorded as 'completed' or 'partially completed' on the Case Report Form at the conclusion of each treatment visit.
measure: Reason for partially completed treatment
time frame: up to 6 months
description: For participants that do not complete both treatment procedures and are categorized as 'incomplete', the reason/s why will be documented.
measure: Supplemental anesthetic use
time frame: up to 6 months
description: Amount of supplemental anesthesia if used for each of the two treatment procedures will be recorded in clinic notes after each treatment procedure.
arm group label: Synapse TENS device
arm group type: Experimental
description: SYnapse TENS device will be used for alleviating pain through electrical stimulation. This is a battery powered device where an electrical current is applied intra-orally on the buccal and lingual sides using an intra-oral pad applicator. This device has been cleared for marketing by the Food and Drug Administration (FDA) and the prescribed electrical field falls almost a 10 factor level lower than routine pulp testing devices used in dentistry. The TENS device was previously tested in a pilot study with promising results. Chair side application and at-home use of the device by the patient was shown to drastically reduce pain and discomfort associated with orthodontic tooth movement.
arm group label: Topical anesthetic gel
arm group type: Active Comparator
description: Topical anesthetic Gel is the active comparator in this study. The topical anesthesia (anesthetic gel) Centrix LolliCaine with 20% benzocaine in single package of 0.3 ml will be used. The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure. This will be done based American Association of Pediatric Dentistry guidelines for the use of local anesthesia.
intervention type: Device
intervention name: Synapse TENS device
description: At the time of local anesthetic application the TENS device will be activated and placed on the buccal and lingual alveolar mucosa adjacent to the tooth receiving the restorative treatment using the pad applicator. The tip of the device with the electrodes are placed in a vertical up and down motion for approximately ten seconds. Following this, the level of pain and anxiety are measured using the Wong Baker Scale and Visual Analog Scale. The TENS device is used for achieving localized pain relief at the site of local anesthetic injection prior to injecting the anesthetic agent (such as lidocaine or articaine). Following this, once the clinician ensures that the patient is pain free then local anesthetic injection is given and following that the dental procedures are conducted.
arm group label: Synapse TENS device
other name: ALEVE therapy
intervention type: Drug
intervention name: Topical anesthetic gel
description: The local anesthetic gel is typically used for achieving localized pain relief at the site of local anesthetic injection and this is part of standard care that is followed prior to dental procedures.
The amount of local anesthetic used will not exceed the maximum allowable dose, which will be calculated for each patient based on his/her age and weight prior to the dental procedure
arm group label: Topical anesthetic gel
other name: Centrix LolliCaine 2% xylocaine with 20% benzocaine
criteria: 
gender: All
minimum age: 6 Years
maximum age: 14 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Jayapriyaa Shanmugham, BDS DrPH
role: Principal Investigator
affiliation: Department of Pediatric Dentistry, Henry M. Goldman School of Dental Medicine
facility: 
country: United States
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PMID: 28879259
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PMID: 28879311
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responsible party type: Sponsor
mesh term: Anesthetics
mesh term: Benzocaine
mesh term: Anesthetics, Local
sharing ipd: Yes
ipd description: Overall findings and summary of results for primary and secondary outcome measures will be made available.
ipd info type: Clinical Study Report (CSR)
ipd time frame: Once data collection is complete and data analysis has been completed the results will be made available.
ipd access criteria: Since this is a pilot study only summary data will be provided.