<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/NCT03005197</url>
  </required_header>
  <id_info>
    <org_study_id>1</org_study_id>
    <nct_id>NCT03005197</nct_id>
  </id_info>
  <brief_title>Laser Doppler Flowmetry in Assessing the Vitality of Traumatised Teeth</brief_title>
  <official_title>A Prospective Study to Assess the Diagnostic Accuracy of Laser Doppler Flowmetry in Assessing Pulp Vitality of Traumatised Teeth in Paediatric Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Leeds</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Leeds</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Teeth injuries are considered one of the most challenging events that occur in dentistry,&#xD;
      especially in children. After an injury, there is a possibility that the blood supply to the&#xD;
      tooth may become affected and compromised leading to nerve and blood vessels death with the&#xD;
      tooth described as a non-vital tooth.&#xD;
&#xD;
      The conventional diagnostic tools available to assess tooth nerve/blood supply are not always&#xD;
      reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure&#xD;
      to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or&#xD;
      de-vitalising a normal tooth which may render the tooth weak for the future and possibly&#xD;
      losing the tooth.&#xD;
&#xD;
      The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more&#xD;
      reliable than the traditional techniques. We aim to assess if this device can predict and&#xD;
      assess whether the tooth is alive or dead during the follow up visits of the injury along the&#xD;
      other conventional tests.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A clinical study will be carried out which consists of a one year follow up to monitoring&#xD;
      traumatised front teeth in children attending the department of paediatric dentistry.&#xD;
&#xD;
      The vitality/sensibility of traumatised teeth will be assessed using laser Doppler flowmetry,&#xD;
      electrical pulp testing and ethyl chloride. Measurements will be performed by a single&#xD;
      operator (chief investigator) and will be carried out at baseline, 3, 6, 9 and 12 months&#xD;
      follow up period.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>February 2017</start_date>
  <completion_date type="Anticipated">May 2018</completion_date>
  <primary_completion_date type="Anticipated">May 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity</measure>
    <time_frame>One year follow up</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Specificity</measure>
    <time_frame>One year follow up</time_frame>
  </primary_outcome>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dental Trauma</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Laser Doppler Flowmetry</intervention_name>
    <other_name>LDF</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients attending the children's dentistry department at Leeds Dental Institute will be&#xD;
        assessed for suitability in taking part into this study according to the study inclusion&#xD;
        and exclusion criteria.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Children would be recruited into this study when they:&#xD;
&#xD;
          -  Between 6-16 years old.&#xD;
&#xD;
          -  Medically fit (ASA I, II).&#xD;
&#xD;
          -  Able to communicate using English language.&#xD;
&#xD;
          -  Have an acceptable level of cooperation.&#xD;
&#xD;
          -  Have at least one traumatised anterior tooth, regardless of the type of trauma, with&#xD;
             uncertain pulpal vitality requiring monitoring for a minimum of 12 months and minimal&#xD;
             coronal restoration (covering less than half the labial crown surface).&#xD;
&#xD;
          -  Have at least one vital and non-traumatised anterior tooth to act as a control.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Medically and mentally compromised children.&#xD;
&#xD;
          -  Children with learning disabilities.&#xD;
&#xD;
          -  Children with communication barrier including those unable to communicate using&#xD;
             English language.&#xD;
&#xD;
          -  Heavily restored teeth covering more than half the labial surface of teeth.&#xD;
&#xD;
          -  Patients on routine analgesics, antidepressants or antihypertensive drugs.&#xD;
&#xD;
          -  Vital teeth with pulp canal obliteration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nahar Ghouth</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Leeds</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Nahar Ghouth, BDS</last_name>
    <phone>0113 343 6228</phone>
    <email>dnnng@leeds.ac.uk</email>
  </overall_contact>
  <reference>
    <citation>Jafarzadeh H. Laser Doppler flowmetry in endodontics: a review. Int Endod J. 2009 Jun;42(6):476-90. doi: 10.1111/j.1365-2591.2009.01548.x.</citation>
    <PMID>19459999</PMID>
  </reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>December 22, 2016</study_first_submitted>
  <study_first_submitted_qc>December 22, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 29, 2016</study_first_posted>
  <last_update_submitted>January 4, 2017</last_update_submitted>
  <last_update_submitted_qc>January 4, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 5, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Leeds</investigator_affiliation>
    <investigator_full_name>Nahar Ghouth</investigator_full_name>
    <investigator_title>Principal Investogator</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03005197
org study id: 1
nct id: NCT03005197
lead sponsor: 
has dmc: No
Teeth injuries are considered one of the most challenging events that occur in dentistry,
      especially in children. After an injury, there is a possibility that the blood supply to the
      tooth may become affected and compromised leading to nerve and blood vessels death with the
      tooth described as a non-vital tooth.

      The conventional diagnostic tools available to assess tooth nerve/blood supply are not always
      reliable. Child cooperation and understanding contribute greatly to this shortfall. Failure
      to assess the vitality of the tooth may result in pain, swelling or infection of the tooth or
      de-vitalising a normal tooth which may render the tooth weak for the future and possibly
      losing the tooth.

      The laser Doppler flowmetry is a non-invasive, non-painful technique and shown to be more
      reliable than the traditional techniques. We aim to assess if this device can predict and
      assess whether the tooth is alive or dead during the follow up visits of the injury along the
      other conventional tests.
A clinical study will be carried out which consists of a one year follow up to monitoring
      traumatised front teeth in children attending the department of paediatric dentistry.

      The vitality/sensibility of traumatised teeth will be assessed using laser Doppler flowmetry,
      electrical pulp testing and ethyl chloride. Measurements will be performed by a single
      operator (chief investigator) and will be carried out at baseline, 3, 6, 9 and 12 months
      follow up period.
observational model: Cohort
time perspective: Prospective
measure: Sensitivity
time frame: One year follow up
measure: Specificity
time frame: One year follow up
intervention type: Device
intervention name: Laser Doppler Flowmetry
other name: LDF
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 6 Years
maximum age: 16 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Nahar Ghouth
role: Principal Investigator
affiliation: University of Leeds
last name: Nahar Ghouth, BDS
phone: 0113 343 6228
email: dnnng@leeds.ac.uk
citation: Jafarzadeh H. Laser Doppler flowmetry in endodontics: a review. Int Endod J. 2009 Jun;42(6):476-90. doi: 10.1111/j.1365-2591.2009.01548.x.
PMID: 19459999
responsible party type: Principal Investigator
investigator affiliation: University of Leeds
investigator full name: Nahar Ghouth
investigator title: Principal Investogator
sharing ipd: No