<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/NCT04414917</url>
  </required_header>
  <id_info>
    <org_study_id>Pro2019002739</org_study_id>
    <secondary_id>1 R21 DA051212-01</secondary_id>
    <nct_id>NCT04414917</nct_id>
  </id_info>
  <brief_title>Reducing Opioid Use and Misuse After Wisdom Molar Extractions</brief_title>
  <official_title>Reducing Opioid Use/Misuse Through Better Pain Control and Active Pill Dispensing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rutgers, The State University of New Jersey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>iPill Dispenser</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Rutgers, The State University of New Jersey</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>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Reducing opioid prescription related use and misuse is a major focus for countering the&#xD;
      national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly&#xD;
      young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth&#xD;
      extractions under sedation and routinely receive postoperative opioid prescriptions. This&#xD;
      procedure is among the most prevalent instances of opioid prescriptions dispensed to&#xD;
      adolescents, a vulnerable population. This overuse can be minimized by bringing about&#xD;
      immediate and sustained pain relief following extractions and by proper monitoring to&#xD;
      regulate post-operative opioid usage.&#xD;
&#xD;
      The investigators developed the Twin block, a local anesthetic nerve block that rapidly eases&#xD;
      pain from the 'closer' muscles of the jaw and showed its long-term effectiveness in patients&#xD;
      with chronic jaw muscle pain. Administering the Twin block immediately following third molar&#xD;
      extractions will be an innovative and effective modality to alleviate acute post-procedure&#xD;
      pain experienced by the patient and hence reduce the need for post-operative opioid pain&#xD;
      medication.&#xD;
&#xD;
      In order to tightly regulate when, how many and to whom the prescribed opioid pill is&#xD;
      accessible, this study will utilize the iPill Dispenser®, an active pill dispenser. The iPill&#xD;
      device, designated as a Class I 510(k) exempt device by the FDA, includes an App that&#xD;
      utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated&#xD;
      device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption&#xD;
      and diversion. The investigators further plan to 'track' pill swallowing by encapsulating the&#xD;
      medication with an ingestible event marker (IEMs, FDA approved Class II device). The&#xD;
      hypothesis of this study is that reduction in opioid prescription and its unwarranted use&#xD;
      following third molar extractions can be achieved by a combination of Twin block, an active&#xD;
      pill dispenser and ingestion tracking. The Specific Aims are:&#xD;
&#xD;
      Specific Aim 1. Compare highest pain after third molar tooth extractions, in patients with&#xD;
      and without the twin block.&#xD;
&#xD;
      Specific Aim 2. Compare postoperative opioid consumption during the first 4 days following&#xD;
      third molar tooth extractions between patients who got the twin block, with those who do not.&#xD;
      Using the iPill dispenser and app and the IEM, the investigators will track opioid&#xD;
      consumption for severe pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Reducing opioid prescription related use and misuse is a major focus for countering the&#xD;
      national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly&#xD;
      young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth&#xD;
      extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al.&#xD;
      2006). This procedure is among the most prevalent instances of opioid prescriptions dispensed&#xD;
      to adolescents and is the subject of a national debate, given the risk for persistent opioid&#xD;
      use and abuse in a vulnerable population (Volkow, McLellan et al. 2011, Dowell, Haegerich et&#xD;
      al. 2016, Groenewald, Rabbitts et al. 2016, Moore, Dionne et al. 2016, Harbaugh, Nalliah et&#xD;
      al. 2018). The investigators believe that this overuse can be minimized by bringing about&#xD;
      immediate and sustained pain relief following extractions and by proper monitoring to&#xD;
      regulate post-operative opioid usage.&#xD;
&#xD;
      Prolonged mouth opening as well as eccentric and isometric contractions, as are typical&#xD;
      during third molar tooth extraction procedures, can result in acute muscle pain in the&#xD;
      masticatory or 'chewing' muscles. However, it is common practice to numb only the actual&#xD;
      tooth extraction site for postoperative pain management, without evaluating for and&#xD;
      addressing acute post-procedure muscle pain. The investigators' preliminary studies have&#xD;
      corroborated the efficacy of the Twin block, a local anesthetic, in the diagnosis and&#xD;
      management of acute and chronic myogenous orofacial pain stemming from the 'chewing muscles'&#xD;
      (Quek, Young et al. 2014, Kanti, Ananthan et al. 2017). The investigators expect that&#xD;
      administering the Twin block immediately following third molar extractions, will be an&#xD;
      innovative and effective modality to alleviate acute post-procedure pain experienced by the&#xD;
      patient and hence reduce the need for post-operative opioid pain medication. Our hypothesis,&#xD;
      therefore, is that reduction in opioid prescription and unwarranted use can be achieved by a&#xD;
      combination of Twin block and an actively monitored pill dispenser. We have selected the&#xD;
      iPill Dispenser® to monitor and regulate post-operative usage.&#xD;
&#xD;
      The iPill device includes an App that utilizes biometric user authentication to operate a&#xD;
      portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid&#xD;
      usage for pain, preventing overconsumption and diversion. Coencapsulating the pain pill with&#xD;
      the IEM will create a virtual 'time-stamp' by triggering a wireless signal from the IEM, when&#xD;
      contacted by stomach acid content, which is detected by a sensor secured on the skin with an&#xD;
      adhesive strip.&#xD;
&#xD;
      Therefore, the Specific Aims are:&#xD;
&#xD;
      Specific Aim 1. Compare peak postoperative pain after third molar tooth extractions, with and&#xD;
      without the twin block, in a randomized blind prospective clinical study Patients undergoing&#xD;
      third molar tooth extractions under 'moderate' (intravenous) sedation, will be randomized to&#xD;
      receive either the twin block or a sham injection on the side of their extraction/s. The Twin&#xD;
      block and sham injection groups will be compared for peak postoperative pain measured using&#xD;
      the numerical pain rating scale (NRS). The investigators predict at least a 50% reduction in&#xD;
      percentage of patients reporting significant pain (NRS≥5), in the group randomized to receive&#xD;
      the twin block.&#xD;
&#xD;
      Specific Aim 2. Compare postoperative opioid consumption during the first 96 hours following&#xD;
      third molar tooth extractions between patients randomized to the control or twin block groups&#xD;
      Using the iPill dispenser and app, the investigators will track IEM-co-encapsulated opioid&#xD;
      consumption for severe pain among patients randomized to either the sham or Twin block arms.&#xD;
      The investigators predict at least a 30% reduction in opioid consumption for severe pain in&#xD;
      the group randomized to receive the Twin block. The investigators expect that utilizing the&#xD;
      iPill dispenser® and app will enforce rigorous, real-time and accurate monitoring of opioid&#xD;
      usage for pain management, overcoming the traditional reliance on patient-reported usage.&#xD;
&#xD;
      POSSIBLE OUTCOMES: This research will potentially transform conventional postoperative pain&#xD;
      management following third molar ('wisdom' tooth) extractions. The investigators expect the&#xD;
      routine incorporation of the twin block to alleviate post-operative pain, thereby reducing&#xD;
      the current reliance on opioid prescriptions in a vulnerable population, especially after a&#xD;
      commonplace procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">November 2023</start_date>
  <completion_date type="Anticipated">April 2025</completion_date>
  <primary_completion_date type="Anticipated">November 2024</primary_completion_date>
  <phase>Phase 2</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>Prospective randomized blind clinical trial of patients undergoing lower third molar extraction/s to evaluate the ability of the Twin block (local anesthetic nerve block) on side of extraction to reduce post-operative pain and pain medication utilization monitoring with an active pill dispenser</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
    <masking_description>Sham injection versus injection of local anesthetic as the Twin block</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Numerical Pain Rating Scale score (NRS)</measure>
    <time_frame>Change in NRS pain scores between baseline and 96 hours post-pain regimen assignment</time_frame>
    <description>Scale from 0 to 10 used to describe no pain (0), mild pain (1-3), moderate (4-6) and severe (7-10) pain. Collection of peak post-procedure, mean, median, quartile pain scores</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain medication consumed (mg)</measure>
    <time_frame>Through 96 hours post-procedure</time_frame>
    <description>Dosage of combination opioid, ibuprofen and acetaminophen consumed</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Incidence of adverse events</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>As described by patients</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPill Dispenser performance- Validation of pills dispensed</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>Validation of pills dispensed- correlation between expected and actual number of remaining pills in each dispensers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPill Dispenser performance- Incidence of dispenser tampering</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>Detection of tampering upon inspection of returned dispensers</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPill Dispenser performance- Incidence of failure of operability</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>Frequency of failed pill dispensing</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>iPill Dispenser performance- Percentage of returned dispensers</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>Percentage of dispensers returned during post-operative visit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IEM relayed record of pill ingestion</measure>
    <time_frame>During the first 4 days following procedure</time_frame>
    <description>Log of pills ingested as relayed to IEM App</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">133</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>Twin Block local anesthetic</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block local anesthetic (using the standard dental anesthetic 1.8 cc 2% lidocaine with 1:100,000 epinephrine), once, on the side/s of their extraction/s</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block injection but with no medication administered/dispensed from the syringe, on the side/s of their extraction/s</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Twin block</intervention_name>
    <description>Dental local anesthetic administered to target the jaw 'closer' muscles, temporalis and masseter</description>
    <arm_group_label>Twin Block local anesthetic</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>iPill dispenser</intervention_name>
    <description>An active pill dispenser, regulated by patient's pain score entered on an iPill App installed on their smart phone (iPhone, Android) to dispense opioid (for pain corresponding to severe pain) or prescription strength ibuprofen and acetaminophen (for moderate pain), with over the counter solutions for mild pain recommended. This pill dispenser will be given to all patients, in both Twin block and Control groups, to regulate and monitor their pain experience-driven pain medication regimen. The pill dispenser will be packaged with pain medication (1 dispenser with vicodin, 1 with prescription ibuprofen, 1 with acetaminophen) that has been coencapsulated with ingestible event markers (IEMs, Proteus Discover).</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Twin Block local anesthetic</arm_group_label>
    <other_name>Active pill dispenser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults (&gt; 18)&#xD;
&#xD;
          2. American Society of Anesthesiologists Classification I&#xD;
&#xD;
          3. No h/o temporomandibular disorder (TMD) symptoms&#xD;
&#xD;
          4. No h/o trauma to jaws/teeth&#xD;
&#xD;
          5. No h/o surgery in maxillofacial region&#xD;
&#xD;
          6. Presenting for extraction of at least 1 mandibular partially bony/ full bony impacted&#xD;
             'wisdom' or third molar/s under intravenous sedation&#xD;
&#xD;
          7. iPhone or Android smart phone (compatible with iPill® App)&#xD;
&#xD;
          8. Informed consent&#xD;
&#xD;
          9. No cognitive/intellectual disability&#xD;
&#xD;
         10. Not from vulnerable population&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Acute infection or pain in relation to the impacted molars on day of procedure&#xD;
&#xD;
          2. h/o opioid prescription for acute/chronic pain&#xD;
&#xD;
          3. h/o of allergy or contraindication to amide-type local anesthetics, epinephrine or&#xD;
             opioids&#xD;
&#xD;
          4. Chronic use of non-steroidal anti-inflammatory drugs (NSAIDs)/muscle relaxants/other&#xD;
             prescriptions to manage pain/inflammation&#xD;
&#xD;
          5. Refusal/inability to use iPill® App or dispenser&#xD;
&#xD;
          6. h/o eczema&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gayathri Subramanian, PhD DMD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers School of Dental Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Anayo Adachie, DMD, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Rutgers School of Dental Medicine</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Gayathri Subramanian, PhD, DMD</last_name>
    <phone>973 972 3418</phone>
    <email>subramga@sdm.rutgers.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Anayo Adachie, DMD, MD</last_name>
    <phone>732 235 5050</phone>
    <email>aoa80@sdm.rutgers.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Rutgers Health University Dental Associates</name>
      <address>
        <city>New Brunswick</city>
        <state>New Jersey</state>
        <zip>08901</zip>
        <country>United States</country>
      </address>
    </facility>
    <contact>
      <last_name>Anayo Adachie, DMD, MD</last_name>
      <phone>732-235-5050</phone>
      <email>aoa80@sdm.rutgers.edu</email>
    </contact>
    <investigator>
      <last_name>Samuel YP Quek, DMD, MPH</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Shuying Jiang, MS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 31, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 11, 2022</last_update_submitted>
  <last_update_submitted_qc>December 11, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 13, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Rutgers, The State University of New Jersey</investigator_affiliation>
    <investigator_full_name>Gayathri Dental Subramanian</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Impacted third molar extraction</keyword>
  <keyword>Acute pain management</keyword>
  <keyword>Active pill dispenser</keyword>
  <keyword>Opioid misuse reduction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>At this time, we have made the commitment to share aggregate data.(We will consider releasing anonymized individual data upon a case by case documented request that the data is being sought for an appropriate reason).&#xD;
With our study design, our basic data will be collected 1. at site of care (dental clinic) and 2. Remotely. Remote data on the app will only be linked with an enrollment number because that data will be collated by our collaborator (Consultant: iPill) and hence will be devoid of identifiers. CRFs will contain data pooled from all the time points in the study and identified only by an enrollment number that will not provide any identifiers. Hence, we will be able to commit to releasing all data collected in this study without compromising patient confidentiality.</ipd_description>
  </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/NCT04414917
org study id: Pro2019002739
secondary id: 1 R21 DA051212-01
nct id: NCT04414917
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
Reducing opioid prescription related use and misuse is a major focus for countering the
      national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly
      young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth
      extractions under sedation and routinely receive postoperative opioid prescriptions. This
      procedure is among the most prevalent instances of opioid prescriptions dispensed to
      adolescents, a vulnerable population. This overuse can be minimized by bringing about
      immediate and sustained pain relief following extractions and by proper monitoring to
      regulate post-operative opioid usage.

      The investigators developed the Twin block, a local anesthetic nerve block that rapidly eases
      pain from the 'closer' muscles of the jaw and showed its long-term effectiveness in patients
      with chronic jaw muscle pain. Administering the Twin block immediately following third molar
      extractions will be an innovative and effective modality to alleviate acute post-procedure
      pain experienced by the patient and hence reduce the need for post-operative opioid pain
      medication.

      In order to tightly regulate when, how many and to whom the prescribed opioid pill is
      accessible, this study will utilize the iPill Dispenser®, an active pill dispenser. The iPill
      device, designated as a Class I 510(k) exempt device by the FDA, includes an App that
      utilizes biometric user authentication to operate a portable tamper-resistant, pre-calibrated
      device to regulate, deliver, and monitor opioid usage for pain, preventing overconsumption
      and diversion. The investigators further plan to 'track' pill swallowing by encapsulating the
      medication with an ingestible event marker (IEMs, FDA approved Class II device). The
      hypothesis of this study is that reduction in opioid prescription and its unwarranted use
      following third molar extractions can be achieved by a combination of Twin block, an active
      pill dispenser and ingestion tracking. The Specific Aims are:

      Specific Aim 1. Compare highest pain after third molar tooth extractions, in patients with
      and without the twin block.

      Specific Aim 2. Compare postoperative opioid consumption during the first 4 days following
      third molar tooth extractions between patients who got the twin block, with those who do not.
      Using the iPill dispenser and app and the IEM, the investigators will track opioid
      consumption for severe pain.
Reducing opioid prescription related use and misuse is a major focus for countering the
      national epidemic of opioid overdose and death. Annually, over 3.5 million predominantly
      young and healthy individuals undergo outpatient third molar ('wisdom tooth') tooth
      extractions and routinely receive postoperative opioid prescription (Moore, Nahouraii et al.
      2006). This procedure is among the most prevalent instances of opioid prescriptions dispensed
      to adolescents and is the subject of a national debate, given the risk for persistent opioid
      use and abuse in a vulnerable population (Volkow, McLellan et al. 2011, Dowell, Haegerich et
      al. 2016, Groenewald, Rabbitts et al. 2016, Moore, Dionne et al. 2016, Harbaugh, Nalliah et
      al. 2018). The investigators believe that this overuse can be minimized by bringing about
      immediate and sustained pain relief following extractions and by proper monitoring to
      regulate post-operative opioid usage.

      Prolonged mouth opening as well as eccentric and isometric contractions, as are typical
      during third molar tooth extraction procedures, can result in acute muscle pain in the
      masticatory or 'chewing' muscles. However, it is common practice to numb only the actual
      tooth extraction site for postoperative pain management, without evaluating for and
      addressing acute post-procedure muscle pain. The investigators' preliminary studies have
      corroborated the efficacy of the Twin block, a local anesthetic, in the diagnosis and
      management of acute and chronic myogenous orofacial pain stemming from the 'chewing muscles'
      (Quek, Young et al. 2014, Kanti, Ananthan et al. 2017). The investigators expect that
      administering the Twin block immediately following third molar extractions, will be an
      innovative and effective modality to alleviate acute post-procedure pain experienced by the
      patient and hence reduce the need for post-operative opioid pain medication. Our hypothesis,
      therefore, is that reduction in opioid prescription and unwarranted use can be achieved by a
      combination of Twin block and an actively monitored pill dispenser. We have selected the
      iPill Dispenser® to monitor and regulate post-operative usage.

      The iPill device includes an App that utilizes biometric user authentication to operate a
      portable tamper-resistant, pre-calibrated device to regulate, deliver, and monitor opioid
      usage for pain, preventing overconsumption and diversion. Coencapsulating the pain pill with
      the IEM will create a virtual 'time-stamp' by triggering a wireless signal from the IEM, when
      contacted by stomach acid content, which is detected by a sensor secured on the skin with an
      adhesive strip.

      Therefore, the Specific Aims are:

      Specific Aim 1. Compare peak postoperative pain after third molar tooth extractions, with and
      without the twin block, in a randomized blind prospective clinical study Patients undergoing
      third molar tooth extractions under 'moderate' (intravenous) sedation, will be randomized to
      receive either the twin block or a sham injection on the side of their extraction/s. The Twin
      block and sham injection groups will be compared for peak postoperative pain measured using
      the numerical pain rating scale (NRS). The investigators predict at least a 50% reduction in
      percentage of patients reporting significant pain (NRS≥5), in the group randomized to receive
      the twin block.

      Specific Aim 2. Compare postoperative opioid consumption during the first 96 hours following
      third molar tooth extractions between patients randomized to the control or twin block groups
      Using the iPill dispenser and app, the investigators will track IEM-co-encapsulated opioid
      consumption for severe pain among patients randomized to either the sham or Twin block arms.
      The investigators predict at least a 30% reduction in opioid consumption for severe pain in
      the group randomized to receive the Twin block. The investigators expect that utilizing the
      iPill dispenser® and app will enforce rigorous, real-time and accurate monitoring of opioid
      usage for pain management, overcoming the traditional reliance on patient-reported usage.

      POSSIBLE OUTCOMES: This research will potentially transform conventional postoperative pain
      management following third molar ('wisdom' tooth) extractions. The investigators expect the
      routine incorporation of the twin block to alleviate post-operative pain, thereby reducing
      the current reliance on opioid prescriptions in a vulnerable population, especially after a
      commonplace procedure.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Prospective randomized blind clinical trial of patients undergoing lower third molar extraction/s to evaluate the ability of the Twin block (local anesthetic nerve block) on side of extraction to reduce post-operative pain and pain medication utilization monitoring with an active pill dispenser
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
masking description: Sham injection versus injection of local anesthetic as the Twin block
measure: Numerical Pain Rating Scale score (NRS)
time frame: Change in NRS pain scores between baseline and 96 hours post-pain regimen assignment
description: Scale from 0 to 10 used to describe no pain (0), mild pain (1-3), moderate (4-6) and severe (7-10) pain. Collection of peak post-procedure, mean, median, quartile pain scores
measure: Pain medication consumed (mg)
time frame: Through 96 hours post-procedure
description: Dosage of combination opioid, ibuprofen and acetaminophen consumed
measure: Incidence of adverse events
time frame: During the first 4 days following procedure
description: As described by patients
measure: iPill Dispenser performance- Validation of pills dispensed
time frame: During the first 4 days following procedure
description: Validation of pills dispensed- correlation between expected and actual number of remaining pills in each dispensers
measure: iPill Dispenser performance- Incidence of dispenser tampering
time frame: During the first 4 days following procedure
description: Detection of tampering upon inspection of returned dispensers
measure: iPill Dispenser performance- Incidence of failure of operability
time frame: During the first 4 days following procedure
description: Frequency of failed pill dispensing
measure: iPill Dispenser performance- Percentage of returned dispensers
time frame: During the first 4 days following procedure
description: Percentage of dispensers returned during post-operative visit
measure: IEM relayed record of pill ingestion
time frame: During the first 4 days following procedure
description: Log of pills ingested as relayed to IEM App
arm group label: Twin Block local anesthetic
arm group type: Experimental
description: Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block local anesthetic (using the standard dental anesthetic 1.8 cc 2% lidocaine with 1:100,000 epinephrine), once, on the side/s of their extraction/s
arm group label: Control
arm group type: Sham Comparator
description: Patients undergoing extractions of lower wisdom molar/s under intravenous sedation will receive the Twin block injection but with no medication administered/dispensed from the syringe, on the side/s of their extraction/s
intervention type: Drug
intervention name: Twin block
description: Dental local anesthetic administered to target the jaw 'closer' muscles, temporalis and masseter
arm group label: Twin Block local anesthetic
intervention type: Device
intervention name: iPill dispenser
description: An active pill dispenser, regulated by patient's pain score entered on an iPill App installed on their smart phone (iPhone, Android) to dispense opioid (for pain corresponding to severe pain) or prescription strength ibuprofen and acetaminophen (for moderate pain), with over the counter solutions for mild pain recommended. This pill dispenser will be given to all patients, in both Twin block and Control groups, to regulate and monitor their pain experience-driven pain medication regimen. The pill dispenser will be packaged with pain medication (1 dispenser with vicodin, 1 with prescription ibuprofen, 1 with acetaminophen) that has been coencapsulated with ingestible event markers (IEMs, Proteus Discover).
arm group label: Control
arm group label: Twin Block local anesthetic
other name: Active pill dispenser
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Gayathri Subramanian, PhD DMD
role: Principal Investigator
affiliation: Rutgers School of Dental Medicine
last name: Anayo Adachie, DMD, MD
role: Principal Investigator
affiliation: Rutgers School of Dental Medicine
last name: Gayathri Subramanian, PhD, DMD
phone: 973 972 3418
email: subramga@sdm.rutgers.edu
last name: Anayo Adachie, DMD, MD
phone: 732 235 5050
email: aoa80@sdm.rutgers.edu
facility: 
contact: 
investigator: 
investigator: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Rutgers, The State University of New Jersey
investigator full name: Gayathri Dental Subramanian
investigator title: Assistant Professor
mesh term: Pain, Postoperative
sharing ipd: No
ipd description: At this time, we have made the commitment to share aggregate data.(We will consider releasing anonymized individual data upon a case by case documented request that the data is being sought for an appropriate reason).
With our study design, our basic data will be collected 1. at site of care (dental clinic) and 2. Remotely. Remote data on the app will only be linked with an enrollment number because that data will be collated by our collaborator (Consultant: iPill) and hence will be devoid of identifiers. CRFs will contain data pooled from all the time points in the study and identified only by an enrollment number that will not provide any identifiers. Hence, we will be able to commit to releasing all data collected in this study without compromising patient confidentiality.