<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/NCT03298165</url>
  </required_header>
  <id_info>
    <org_study_id>cebc-cu-2017-09-25</org_study_id>
    <nct_id>NCT03298165</nct_id>
  </id_info>
  <brief_title>The Microbiological Assessment of Deep Carious Lesions After Step-wise Excavation and Diode Laser Cavity Disinfection .</brief_title>
  <official_title>Diode Laser Cavity Disinfection (A Six Month Randomized Clinical Trial).</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to assess antibacterial effect of the diode laser in deep&#xD;
      carious cavity after step wise excavation using the bacteriological assessment method.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      each patient should have at least two deep carious lesions The first clinical step in all&#xD;
      teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the&#xD;
      lateral walls of the cavity and at the enamel-dentin junction was completely removed with&#xD;
      excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic&#xD;
      biomasses and superficial part of the necrotic and demineralized dentin were removed. then&#xD;
      excavation continued until the pulp exposure would occur with further excavation; thus, a&#xD;
      layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.&#xD;
&#xD;
      A dentine samples will be then collected from the base of the cavity using sterile spoon&#xD;
      excavator from the both groups for baseline bacteriological assessment and another sample&#xD;
      will be taken after disinfection with diode laser in the intervention group .&#xD;
&#xD;
      In the two groups The remaining innermost layer of carious dentin are covered with calcium&#xD;
      hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer)&#xD;
      after a 6 month period. This time was considered adequate for calcium hydroxide to exert its&#xD;
      effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were&#xD;
      followed up every month and the integrity of the temporary restoration checked. After this&#xD;
      interval of 6 months. After the rubber dam application, the temporary filling is removed&#xD;
      samples are collected and the teeth are finally restored&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2018</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">March 15, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>outcome assessor the assessor will not be blind about the type of intervention/control assessment methods. however it will not be allowed amongst the examiners to exchange any information throughout the entire study period</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>bacteriological count</measure>
    <time_frame>30 minute</time_frame>
    <description>dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Antibacterial Effect of Diode Laser</condition>
  <arm_group>
    <arm_group_label>disinfection the cavity with diode laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no cavity disinfection</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>diode laser</intervention_name>
    <description>diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation</description>
    <arm_group_label>disinfection the cavity with diode laser</arm_group_label>
    <arm_group_label>no cavity disinfection</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with at least two deep occlusal carious lesion .&#xD;
&#xD;
          2. 18 - 25years.&#xD;
&#xD;
          3. Males or Females.&#xD;
&#xD;
          4. Good oral hygiene.&#xD;
&#xD;
          5. Co-operative patients approving the trial and willing to sign a written consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy.&#xD;
&#xD;
          2. Systemic disease or severe medical complications.&#xD;
&#xD;
          3. Heavy smoking.&#xD;
&#xD;
          4. Xerostomia.&#xD;
&#xD;
          5. Lack of compliance.&#xD;
&#xD;
          6. Evidence of temporomandibular joint disorders.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>25 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 27, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 2, 2017</study_first_posted>
  <last_update_submitted>January 23, 2018</last_update_submitted>
  <last_update_submitted_qc>January 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 25, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>shahenda gamal tawfik hamdy</investigator_full_name>
    <investigator_title>internal resident</investigator_title>
  </responsible_party>
  <!-- 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/NCT03298165
org study id: cebc-cu-2017-09-25
nct id: NCT03298165
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study will be conducted to assess antibacterial effect of the diode laser in deep
      carious cavity after step wise excavation using the bacteriological assessment method.
each patient should have at least two deep carious lesions The first clinical step in all
      teeth will be the opening of the cavity and the removal of undermined enamel . Caries at the
      lateral walls of the cavity and at the enamel-dentin junction was completely removed with
      excavators and/or round carbide burs at low speed. Subsequently, the central cariogenic
      biomasses and superficial part of the necrotic and demineralized dentin were removed. then
      excavation continued until the pulp exposure would occur with further excavation; thus, a
      layer of soft carious dentin was left on the cavity floor adjacent to the pulp wall.

      A dentine samples will be then collected from the base of the cavity using sterile spoon
      excavator from the both groups for baseline bacteriological assessment and another sample
      will be taken after disinfection with diode laser in the intervention group .

      In the two groups The remaining innermost layer of carious dentin are covered with calcium
      hydroxide The cavity was then sealed with restorative material (resin modified glass ionomer)
      after a 6 month period. This time was considered adequate for calcium hydroxide to exert its
      effect and for the pulp to respond with possible formation of tertiary dentin. The teeth were
      followed up every month and the integrity of the temporary restoration checked. After this
      interval of 6 months. After the rubber dam application, the temporary filling is removed
      samples are collected and the teeth are finally restored
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Single (Outcomes Assessor)
masking description: outcome assessor the assessor will not be blind about the type of intervention/control assessment methods. however it will not be allowed amongst the examiners to exchange any information throughout the entire study period
measure: bacteriological count
time frame: 30 minute
description: dentine samples will be taken before and after application of diode laser then bacteriological assessment will be done in the micro-lab
arm group label: disinfection the cavity with diode laser
arm group type: Experimental
description: diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation
arm group label: no cavity disinfection
arm group type: Placebo Comparator
description: placebo is used as no cavity disinfection will be done as after excavation the restoration will be placed .
intervention type: Device
intervention name: diode laser
description: diode laser has antibacterial effect so can disinfect deep cavity and decrease the count of bacteria present after stepwise excavation
arm group label: disinfection the cavity with diode laser
arm group label: no cavity disinfection
criteria: 
gender: All
minimum age: 18 Years
maximum age: 25 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: shahenda gamal tawfik hamdy
investigator title: internal resident