<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/NCT04446364</url>
  </required_header>
  <id_info>
    <org_study_id>Ethanolic Extract of Aloe vera</org_study_id>
    <nct_id>NCT04446364</nct_id>
  </id_info>
  <brief_title>Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant.</brief_title>
  <official_title>Ethanolic Extract of Aloe Vera Versus Chlorohexidine as Cavity Disinfectant: A Split-mouth 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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This Randomized Clinical Trial will be conducted to compare the efficacy of ethanolic extract&#xD;
      of Aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of&#xD;
      Streptococcus mutans (SM) and Lactobacilli (LB).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Dental caries remains to be a major oral health problem afflicting people, young and old,&#xD;
      especially in developing and underdeveloped countries. Though dentistry has magically&#xD;
      developed with newer materials and newer techniques, dental caries remains a disease of great&#xD;
      prevalence.&#xD;
&#xD;
      The prevention and control of caries necessitates the elimination of cariogenic bacteria that&#xD;
      produce acids responsible for the decrease of pH and starting the process of&#xD;
      demineralization.&#xD;
&#xD;
      While the goal of restorative treatments for dental caries is to remove the infected dentin&#xD;
      and fill the area with a suitable restorative material, failure to remove the infected teeth&#xD;
      surface totally and achieve complete sterilization of the cavity can lead to microleakage,&#xD;
      increased pulp sensitivity, pulpal infection and secondary caries that necessitate&#xD;
      replacement of restoration.&#xD;
&#xD;
      Therefore, after removal of the carious dentin it is important to eliminate any remaining&#xD;
      bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin&#xD;
      junction, or in the dentinal tubules. But unfortunately, no definitive and reliable criteria&#xD;
      are available to ensure the complete removal of carious tooth structure. Many investigations&#xD;
      have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin.&#xD;
&#xD;
      Due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant&#xD;
      and posing a serious threat in rendering successful treatment of the diseases. With the rise&#xD;
      in bacterial resistance to various synthetic antimicrobial agents, there is a considerable&#xD;
      interest and a growing trend in the field.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">September 1, 2020</start_date>
  <completion_date type="Anticipated">September 1, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2021</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>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bacterial reduction</measure>
    <time_frame>one year</time_frame>
    <description>Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pulp vitality</measure>
    <time_frame>one year</time_frame>
    <description>Pulp should be vital instead of death of pulp and loose its vitality</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">32</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>Aloe vera group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gel cavity disinfection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chlorohexidine group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2% cavity disinfection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Ethanolic extract of Aloe vera gel cavity disinfectant</intervention_name>
    <description>Application of Aloe vera gel after partial caries removal then taking dentin bacterial sample to be sure for reduction of bacterial count (streptococcus mutans and Lactobacillus) in deep cavity then add final restoration</description>
    <arm_group_label>Aloe vera group</arm_group_label>
    <arm_group_label>Chlorohexidine group</arm_group_label>
    <other_name>Aloe vera</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Chlorohexadine</intervention_name>
    <description>2%Chlorohexadine add on deep cavity as cavity disinfection after partial caries removal. Pre and post excavation bacterial count to measure bacterial reduction then add final restoration</description>
    <arm_group_label>Aloe vera group</arm_group_label>
    <arm_group_label>Chlorohexidine group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Patients with at least two occlusal deep carious lesions, one on each side,&#xD;
             preferred from the same arch.&#xD;
&#xD;
               -  Age range 20-50 years.&#xD;
&#xD;
               -  Systematically health.&#xD;
&#xD;
               -  Adults who were able to give informed consent.&#xD;
&#xD;
               -  Teeth with radiographic evidence of carious lesion that penetrated at least the&#xD;
                  inner one half of the dentin thickness.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Patients with clinical and radiographic signs of pulpal involvement.&#xD;
&#xD;
               -  Patients unable to return for recall appointments.&#xD;
&#xD;
               -  Inability of a patient to give informed consent.&#xD;
&#xD;
               -  Teeth with clinical and radiographic sign of pulpal involvement.&#xD;
&#xD;
               -  Teeth where isolation with a rubber dam was not possible&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Sara Ibrahim Hedia, M.D.S</last_name>
    <phone>(0020)1157371420</phone>
    <email>sara.hedia@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Rasha Raafat Hassan, Assistant Proffesor</last_name>
    <phone>(0020)1006555335</phone>
    <email>Rasha.Raafat@dentistry.cu.edu.eg</email>
  </overall_contact_backup>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 22, 2020</study_first_submitted>
  <study_first_submitted_qc>June 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 24, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Sara Ibrahim Ahmed Hedia</investigator_full_name>
    <investigator_title>Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Disinfectants</mesh_term>
  </intervention_browse>
  <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/NCT04446364
org study id: Ethanolic Extract of Aloe vera
nct id: NCT04446364
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This Randomized Clinical Trial will be conducted to compare the efficacy of ethanolic extract
      of Aloe vera versus chlorhexidine cavity disinfectant in reducing total bacterial count of
      Streptococcus mutans (SM) and Lactobacilli (LB).
Dental caries remains to be a major oral health problem afflicting people, young and old,
      especially in developing and underdeveloped countries. Though dentistry has magically
      developed with newer materials and newer techniques, dental caries remains a disease of great
      prevalence.

      The prevention and control of caries necessitates the elimination of cariogenic bacteria that
      produce acids responsible for the decrease of pH and starting the process of
      demineralization.

      While the goal of restorative treatments for dental caries is to remove the infected dentin
      and fill the area with a suitable restorative material, failure to remove the infected teeth
      surface totally and achieve complete sterilization of the cavity can lead to microleakage,
      increased pulp sensitivity, pulpal infection and secondary caries that necessitate
      replacement of restoration.

      Therefore, after removal of the carious dentin it is important to eliminate any remaining
      bacteria that may be present on the cavity walls, in the smear layer, at the enamel-dentin
      junction, or in the dentinal tubules. But unfortunately, no definitive and reliable criteria
      are available to ensure the complete removal of carious tooth structure. Many investigations
      have shown the presence of bacteria in the dentin even after removal of dye-stainable dentin.

      Due to indiscriminate use of antimicrobials more and more pathogens are becoming resistant
      and posing a serious threat in rendering successful treatment of the diseases. With the rise
      in bacterial resistance to various synthetic antimicrobial agents, there is a considerable
      interest and a growing trend in the field.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Bacterial reduction
time frame: one year
description: Reduction of total bacterial count of SM and LB. IT will be measured before and after cavity disinfectant.
measure: Pulp vitality
time frame: one year
description: Pulp should be vital instead of death of pulp and loose its vitality
arm group label: Aloe vera group
arm group type: Experimental
description: Gel cavity disinfection
arm group label: Chlorohexidine group
arm group type: Active Comparator
description: 2% cavity disinfection
intervention type: Other
intervention name: Ethanolic extract of Aloe vera gel cavity disinfectant
description: Application of Aloe vera gel after partial caries removal then taking dentin bacterial sample to be sure for reduction of bacterial count (streptococcus mutans and Lactobacillus) in deep cavity then add final restoration
arm group label: Aloe vera group
arm group label: Chlorohexidine group
other name: Aloe vera
intervention type: Other
intervention name: Chlorohexadine
description: 2%Chlorohexadine add on deep cavity as cavity disinfection after partial caries removal. Pre and post excavation bacterial count to measure bacterial reduction then add final restoration
arm group label: Aloe vera group
arm group label: Chlorohexidine group
criteria: 
gender: All
minimum age: 20 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sara Ibrahim Hedia, M.D.S
phone: (0020)1157371420
email: sara.hedia@dentistry.cu.edu.eg
last name: Rasha Raafat Hassan, Assistant Proffesor
phone: (0020)1006555335
email: Rasha.Raafat@dentistry.cu.edu.eg
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Sara Ibrahim Ahmed Hedia
investigator title: Master degree studnet, Conservative Dentistry Department, Faculty of Dentistry, Cairo University.
mesh term: Dental Caries
mesh term: Disinfectants
sharing ipd: No