<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/NCT01683851</url>
  </required_header>
  <id_info>
    <org_study_id>HSC200120233H</org_study_id>
    <nct_id>NCT01683851</nct_id>
  </id_info>
  <brief_title>Isolite and Dental Treatment Under Conscious Sedation</brief_title>
  <official_title>Isolite and Dental Treatment Under Conscious Sedation: a Pilot Study to Assess the Upper Airway in a Pediatric Population</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The University of Texas Health Science Center at San Antonio</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The University of Texas Health Science Center at San Antonio</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Hypothesis&#xD;
&#xD;
      The use of Isolite® system does not produce upper airway obstruction in the pediatric&#xD;
      population during dental treatment with conscious sedation.&#xD;
&#xD;
      Purpose:&#xD;
&#xD;
      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is&#xD;
      used for dental treatment with conscious sedation.&#xD;
&#xD;
      Objectives:&#xD;
&#xD;
        1. Determine changes in pulse rate&#xD;
&#xD;
        2. Determine changes in SpO2&#xD;
&#xD;
        3. Recognize breath sound's changes possibly associated with airway blockage&#xD;
&#xD;
        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental&#xD;
           treatment under conscious sedation&#xD;
&#xD;
        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is&#xD;
      used for dental treatment with conscious sedation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2012</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Isolite and Dental Treatment Under Conscious Sedation</measure>
    <time_frame>120 minutes (sedation appointment time)</time_frame>
    <description>In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam.&#xD;
Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Isolite and Dental Treatment Under Conscious Sedation</measure>
    <time_frame>120 minutes (sedation appointment)</time_frame>
    <description>Finally, it is important to recognize that this is a pilot study with limitations, including:&#xD;
A small number of participants&#xD;
No group control&#xD;
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.&#xD;
Conclusions:&#xD;
The results of this pilot study suggest the following conclusions:&#xD;
Isolite ® may be safely used during pediatric dental treatment under conscious sedation.&#xD;
The successful use of Isolite ® is related to the patient's behavior. The weakness aspect of Isolite ® is the soft bite block that allows the youngest patients to chew on it.&#xD;
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Dental Caries</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Isolite System</intervention_name>
    <description>A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.</description>
    <other_name>Isolite</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Pediatric patients in need of a sedation dental appointment&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  ASA I (no systemic disease), ASA II (mid systemic disease-well controlled)&#xD;
&#xD;
          -  4-7 years of age&#xD;
&#xD;
          -  Patients English and Spanish speaking&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Upper airway infection&#xD;
&#xD;
          -  Craniofacial anomalies&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>7 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Claudia I Contreras, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Texas</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University of Texas Health Science Center-Dental School</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78229</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Texas Health Science Center-Ricardo Salinas Dental Clinic</name>
      <address>
        <city>San Antonio</city>
        <state>Texas</state>
        <zip>78237</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Kameyama A, Asami M, Noro A, Abo H, Hirai Y, Tsunoda M. The effects of three dry-field techniques on intraoral temperature and relative humidity. J Am Dent Assoc. 2011 Mar;142(3):274-80. doi: 10.14219/jada.archive.2011.0166.</citation>
    <PMID>21357861</PMID>
  </reference>
  <reference>
    <citation>Pena BM, Krauss B. Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med. 1999 Oct;34(4 Pt 1):483-91. doi: 10.1016/s0196-0644(99)80050-x.</citation>
    <PMID>10499949</PMID>
  </reference>
  <reference>
    <citation>Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44. doi: 10.1542/peds.106.4.633.</citation>
    <PMID>11015502</PMID>
  </reference>
  <reference>
    <citation>Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.</citation>
    <PMID>10742324</PMID>
  </reference>
  <reference>
    <citation>Noro A, Kameyama A, Asami M, Sugiyama T, Morinaga K, Kondou Y, Tsunoda M. Clinical usefulness of &quot;Isolite Plus&quot; for oral environment of Japanese people. Bull Tokyo Dent Coll. 2009 Aug;50(3):149-55. doi: 10.2209/tdcpublication.50.149.</citation>
    <PMID>19887758</PMID>
  </reference>
  <reference>
    <citation>Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.</citation>
    <PMID>20483019</PMID>
  </reference>
  <reference>
    <citation>American Academy on Pediatrics; American Academy on Pediatric Dentistry. Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatr Dent. 2008-2009;30(7 Suppl):143-59.</citation>
    <PMID>19216414</PMID>
  </reference>
  <reference>
    <citation>Leelataweedwud P, Vann WF Jr. Adverse events and outcomes of conscious sedation for pediatric patients: study of an oral sedation regimen. J Am Dent Assoc. 2001 Nov;132(11):1531-9; quiz 1596. doi: 10.14219/jada.archive.2001.0086.</citation>
    <PMID>11811136</PMID>
  </reference>
  <reference>
    <citation>Meurice JC, Marc I, Carrier G, Series F. Effects of mouth opening on upper airway collapsibility in normal sleeping subjects. Am J Respir Crit Care Med. 1996 Jan;153(1):255-9. doi: 10.1164/ajrccm.153.1.8542125.</citation>
    <PMID>8542125</PMID>
  </reference>
  <reference>
    <citation>MORIKAWA S, SAFAR P, DECARLO J. Influence of the headjaw position upon upper airway patency. Anesthesiology. 1961 Mar-Apr;22:265-70. doi: 10.1097/00000542-196103000-00016. No abstract available.</citation>
    <PMID>13772661</PMID>
  </reference>
  <reference>
    <citation>Verin E, Series F, Locher C, Straus C, Zelter M, Derenne JP, Similowski T. Effects of neck flexion and mouth opening on inspiratory flow dynamics in awake humans. J Appl Physiol (1985). 2002 Jan;92(1):84-92. doi: 10.1152/jappl.2002.92.1.84.</citation>
    <PMID>11744646</PMID>
  </reference>
  <reference>
    <citation>Dickison AE. The normal and abnormal pediatric upper airway. Recognition and management of obstruction. Clin Chest Med. 1987 Dec;8(4):583-96.</citation>
    <PMID>3322644</PMID>
  </reference>
  <reference>
    <citation>Iwatani K, Matsuo K, Kawase S, Wakimoto N, Taguchi A, Ogasawara T. Effects of open mouth and rubber dam on upper airway patency and breathing. Clin Oral Investig. 2013 Jun;17(5):1295-9. doi: 10.1007/s00784-012-0810-5. Epub 2012 Aug 3.</citation>
    <PMID>22864529</PMID>
  </reference>
  <reference>
    <citation>Ito H, Kawaai H, Yamazaki S, Suzuki Y. Maximum opening of the mouth by mouth prop during dental procedures increases the risk of upper airway constriction. Ther Clin Risk Manag. 2010 May 25;6:239-48. doi: 10.2147/tcrm.s10187.</citation>
    <PMID>20526442</PMID>
  </reference>
  <reference>
    <citation>Bingham RM, Proctor LT. Airway management. Pediatr Clin North Am. 2008 Aug;55(4):873-86, ix-x. doi: 10.1016/j.pcl.2008.04.004.</citation>
    <PMID>18675024</PMID>
  </reference>
  <verification_date>December 2013</verification_date>
  <study_first_submitted>September 7, 2012</study_first_submitted>
  <study_first_submitted_qc>September 11, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>December 12, 2013</last_update_submitted>
  <last_update_submitted_qc>December 12, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 13, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The University of Texas Health Science Center at San Antonio</investigator_affiliation>
    <investigator_full_name>Claudia Isabel Contreras</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <keyword>pediatric</keyword>
  <keyword>conscious sedation</keyword>
  <keyword>mouthpiece</keyword>
  <keyword>airway</keyword>
  <keyword>isolite system</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <!-- 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/NCT01683851
org study id: HSC200120233H
nct id: NCT01683851
lead sponsor: 
has dmc: No
Hypothesis

      The use of Isolite® system does not produce upper airway obstruction in the pediatric
      population during dental treatment with conscious sedation.

      Purpose:

      Report the changes in airway patency and pediatric patient's behavior when Isolite® system is
      used for dental treatment with conscious sedation.

      Objectives:

        1. Determine changes in pulse rate

        2. Determine changes in SpO2

        3. Recognize breath sound's changes possibly associated with airway blockage

        4. Evaluate if the isolite® system is well tolerate by the pediatric population for dental
           treatment under conscious sedation

        5. Relate the use of Isolite® with the frequency of head reposition to open the airway.
Report the changes in airway patency and pediatric patient's behavior when Isolite® system is
      used for dental treatment with conscious sedation.
time perspective: Prospective
measure: Isolite and Dental Treatment Under Conscious Sedation
time frame: 120 minutes (sedation appointment time)
description: In this study all patients were Mallampati 1 and Brodsky 2. The device comes in 4 sizes: pedo, small, medium and large. The most commonly used was pedo 65% (13) and small 35% (7). Eighty percent (16) of sedations had a satisfactory experience with Isolite ®, Twenty percent (4) had unsatisfactory outcome due to disruptive behavior. Of these 4 cases 2 patients were medicated with meperidine + hydroxyzine and the other 2 with midazolam.
Fifty percent (8) of the patients successfully treated with Isolite ® experienced snoring and head reposition was performed to open airway. The level of sedation according to the AAPD guidelines was moderate in these events in which snoring occurred. The concentration of nitrous oxide-oxygen was adjusted so that more oxygen was given and the patient would be more alert. No significant changes in SpO2 (mean 99.8) or pulse were observed (mean 90.6).
measure: Isolite and Dental Treatment Under Conscious Sedation
time frame: 120 minutes (sedation appointment)
description: Finally, it is important to recognize that this is a pilot study with limitations, including:
A small number of participants
No group control
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.
Conclusions:
The results of this pilot study suggest the following conclusions:
Isolite ® may be safely used during pediatric dental treatment under conscious sedation.
The successful use of Isolite ® is related to the patient's behavior. The weakness aspect of Isolite ® is the soft bite block that allows the youngest patients to chew on it.
Therefore, this study's findings need to be tempered by implications contained within these limitations and further research seems indicated.
intervention type: Device
intervention name: Isolite System
description: A type of isolation system used in dentistry. It protects soft tissues, and also has a mouth prop, which helps keep mouth open.
other name: Isolite
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 4 Years
maximum age: 7 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Claudia I Contreras, DDS
role: Principal Investigator
affiliation: University of Texas
facility: 
facility: 
country: United States
citation: Kameyama A, Asami M, Noro A, Abo H, Hirai Y, Tsunoda M. The effects of three dry-field techniques on intraoral temperature and relative humidity. J Am Dent Assoc. 2011 Mar;142(3):274-80. doi: 10.14219/jada.archive.2011.0166.
PMID: 21357861
citation: Pena BM, Krauss B. Adverse events of procedural sedation and analgesia in a pediatric emergency department. Ann Emerg Med. 1999 Oct;34(4 Pt 1):483-91. doi: 10.1016/s0196-0644(99)80050-x.
PMID: 10499949
citation: Cote CJ, Karl HW, Notterman DA, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: analysis of medications used for sedation. Pediatrics. 2000 Oct;106(4):633-44. doi: 10.1542/peds.106.4.633.
PMID: 11015502
citation: Cote CJ, Notterman DA, Karl HW, Weinberg JA, McCloskey C. Adverse sedation events in pediatrics: a critical incident analysis of contributing factors. Pediatrics. 2000 Apr;105(4 Pt 1):805-14. doi: 10.1542/peds.105.4.805.
PMID: 10742324
citation: Noro A, Kameyama A, Asami M, Sugiyama T, Morinaga K, Kondou Y, Tsunoda M. Clinical usefulness of "Isolite Plus" for oral environment of Japanese people. Bull Tokyo Dent Coll. 2009 Aug;50(3):149-55. doi: 10.2209/tdcpublication.50.149.
PMID: 19887758
citation: Collette J, Wilson S, Sullivan D. A study of the Isolite system during sealant placement: efficacy and patient acceptance. Pediatr Dent. 2010 Mar-Apr;32(2):146-50.
PMID: 20483019
citation: American Academy on Pediatrics; American Academy on Pediatric Dentistry. Guideline for monitoring and management of pediatric patients during and after sedation for diagnostic and therapeutic procedures. Pediatr Dent. 2008-2009;30(7 Suppl):143-59.
PMID: 19216414
citation: Leelataweedwud P, Vann WF Jr. Adverse events and outcomes of conscious sedation for pediatric patients: study of an oral sedation regimen. J Am Dent Assoc. 2001 Nov;132(11):1531-9; quiz 1596. doi: 10.14219/jada.archive.2001.0086.
PMID: 11811136
citation: Meurice JC, Marc I, Carrier G, Series F. Effects of mouth opening on upper airway collapsibility in normal sleeping subjects. Am J Respir Crit Care Med. 1996 Jan;153(1):255-9. doi: 10.1164/ajrccm.153.1.8542125.
PMID: 8542125
citation: MORIKAWA S, SAFAR P, DECARLO J. Influence of the headjaw position upon upper airway patency. Anesthesiology. 1961 Mar-Apr;22:265-70. doi: 10.1097/00000542-196103000-00016. No abstract available.
PMID: 13772661
citation: Verin E, Series F, Locher C, Straus C, Zelter M, Derenne JP, Similowski T. Effects of neck flexion and mouth opening on inspiratory flow dynamics in awake humans. J Appl Physiol (1985). 2002 Jan;92(1):84-92. doi: 10.1152/jappl.2002.92.1.84.
PMID: 11744646
citation: Dickison AE. The normal and abnormal pediatric upper airway. Recognition and management of obstruction. Clin Chest Med. 1987 Dec;8(4):583-96.
PMID: 3322644
citation: Iwatani K, Matsuo K, Kawase S, Wakimoto N, Taguchi A, Ogasawara T. Effects of open mouth and rubber dam on upper airway patency and breathing. Clin Oral Investig. 2013 Jun;17(5):1295-9. doi: 10.1007/s00784-012-0810-5. Epub 2012 Aug 3.
PMID: 22864529
citation: Ito H, Kawaai H, Yamazaki S, Suzuki Y. Maximum opening of the mouth by mouth prop during dental procedures increases the risk of upper airway constriction. Ther Clin Risk Manag. 2010 May 25;6:239-48. doi: 10.2147/tcrm.s10187.
PMID: 20526442
citation: Bingham RM, Proctor LT. Airway management. Pediatr Clin North Am. 2008 Aug;55(4):873-86, ix-x. doi: 10.1016/j.pcl.2008.04.004.
PMID: 18675024
responsible party type: Principal Investigator
investigator affiliation: The University of Texas Health Science Center at San Antonio
investigator full name: Claudia Isabel Contreras
investigator title: Professor
mesh term: Dental Caries