<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/NCT01730287</url>
  </required_header>
  <id_info>
    <org_study_id>AZadUMS-</org_study_id>
    <nct_id>NCT01730287</nct_id>
  </id_info>
  <brief_title>Effect Of Different Lining Materials in Stepwise Excavation</brief_title>
  <official_title>Effect Of Different Lining Materials on Clinical Symptoms of Stepwise Excavation Without Re-enter: Double Blind Randomizd Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Azad University of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Azad University of Medical Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Deep carious lesions will encounter the dentist with the challenge of selecting a treatment&#xD;
      method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional&#xD;
      restorative treatments suggest complete removal of the caries in one visit which could cause&#xD;
      pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root&#xD;
      Canal Therapy (RCT).&#xD;
&#xD;
      Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the&#xD;
      possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp&#xD;
      Capping (IPC), in this technique only the central infected part of the caries is removed in&#xD;
      first visit and the rest of the caries will be lined by a suitable material to suppress the&#xD;
      remained cariogenic biomass and seal the cavity. This will help the pulp to defend and&#xD;
      survive. After a period, the cavity is re-opened and the rest of the caries which is darker,&#xD;
      harder and with less bacteria will be removed and the tooth is restored permanently.The aim&#xD;
      of this study was to compare the effect of different lining materials in clinical and&#xD;
      radiographical symptoms in stepwise excavation without re-enter after one year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In this randomized clinical trial of 4 lining materials have been applied in deep caries&#xD;
      teeth in stepwise excavation. The common material which is applied as a liner over the&#xD;
      remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility&#xD;
      of this liner over time which could interact with sealing of the cavity in long term. It&#xD;
      seems that a material with antibacterial activity, good sealing ability and suitable&#xD;
      mechanical properties could cause SE be done efficiently with good prognosis.&#xD;
&#xD;
      MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good&#xD;
      sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good&#xD;
      antibacterial effect like CH with sealing ability that is proposed to be similar to MTA&#xD;
      according to its double sealing property. CEM cement has been suggested as a suitable&#xD;
      material in pulp capping of permanent molars with irreversible pulpitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>May 2010</start_date>
  <completion_date type="Anticipated">May 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2012</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pulpal Vitality</measure>
    <time_frame>One year</time_frame>
    <description>Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Dental Pulp Necrosis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>No lining applied in group1.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CEM cement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CEM cement applied over remained caries in group4.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Mineral Trioxide Aggregate (MTA)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>MTA applied over remained caries in group3.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Calcium Hydroxide applied over remained caries in group2.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>The teeth in this group restored only by filling material,without liner application.</description>
    <arm_group_label>Control</arm_group_label>
    <other_name>NO liner applied.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Calcium Hydroxide</intervention_name>
    <description>Calcium Hydroxide paste applied.</description>
    <arm_group_label>Calcium Hydroxide</arm_group_label>
    <other_name>Calcium Hydroxide paste , Dycal,Dentsply.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Mineral Trioxide Aggregate(MTA)</intervention_name>
    <description>MTA applied .</description>
    <arm_group_label>Mineral Trioxide Aggregate (MTA)</arm_group_label>
    <other_name>MTA, white MTA, ProRoot,Dentsply.</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>CEM cement</intervention_name>
    <description>CEM cement applied .</description>
    <arm_group_label>CEM cement</arm_group_label>
    <other_name>CEM cement, Yektazist,Iran.</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        A tooth with deep caries lesion - Tooth at risk of pulpal exposure - No pulpal ,&#xD;
        instantaneous , night pain&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Unbearable pain of the involved tooth- Apical radiolucency of the tooth- PDL widening&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>45 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sepideh Banava, Assist-Prof</last_name>
    <role>Study Chair</role>
    <affiliation>Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sepideh Banava, Assist-prof</last_name>
    <phone>982188882321</phone>
    <email>sbanava@yahoo.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Mohammad Safaie Yazdi, Dentist</last_name>
    <phone>00989123614034</phone>
    <email>mohammad.safaei@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Azad University of Medical Sciences, Dental Branch</name>
      <address>
        <city>Tehran</city>
        <state>N/A = Not Applicable</state>
        <zip>1517884111</zip>
        <country>Iran, Islamic Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sepideh Banava, Assist-Prof</last_name>
      <phone>982188882321</phone>
      <email>sbanava@yahoo.com</email>
    </contact>
    <contact_backup>
      <last_name>Mohammad Safaie Yazdi, Dentist</last_name>
      <phone>00989123614034</phone>
      <email>mohammad.safaei@yahoo.com</email>
    </contact_backup>
    <investigator>
      <last_name>Sepideh Banava, Assist-Prof</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Iran, Islamic Republic of</country>
  </location_countries>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 20, 2012</last_update_submitted>
  <last_update_submitted_qc>November 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Azad University of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Sepideh Banava.DDS,MS</investigator_full_name>
    <investigator_title>Assist-Prof</investigator_title>
  </responsible_party>
  <keyword>Stepwise Excavation</keyword>
  <keyword>Pulpal vitality</keyword>
  <keyword>Deep caries lesions</keyword>
  <keyword>Clinical symptoms</keyword>
  <keyword>Radiographic evaluation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Pulp Necrosis</mesh_term>
    <mesh_term>Necrosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Calcium, Dietary</mesh_term>
    <mesh_term>Calcium</mesh_term>
  </intervention_browse>
  <pending_results>
    <submitted>May 15, 2016</submitted>
    <submission_canceled>Unknown</submission_canceled>
  </pending_results>
  <!-- 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/NCT01730287
org study id: AZadUMS-
nct id: NCT01730287
lead sponsor: 
has dmc: Yes
Deep carious lesions will encounter the dentist with the challenge of selecting a treatment
      method that could avoid the pulpal exposure and maintain the pulp vitality.Conventional
      restorative treatments suggest complete removal of the caries in one visit which could cause
      pulpal exposure in 53% of the cases which in next step needs pulpotomy, pulpectomy or Root
      Canal Therapy (RCT).

      Stepwise Excavation(SE)is an old concept but has been researched recently to reduce the
      possibility pulpal exposure during the removal of the lesion. Contrary to Indirect Pulp
      Capping (IPC), in this technique only the central infected part of the caries is removed in
      first visit and the rest of the caries will be lined by a suitable material to suppress the
      remained cariogenic biomass and seal the cavity. This will help the pulp to defend and
      survive. After a period, the cavity is re-opened and the rest of the caries which is darker,
      harder and with less bacteria will be removed and the tooth is restored permanently.The aim
      of this study was to compare the effect of different lining materials in clinical and
      radiographical symptoms in stepwise excavation without re-enter after one year.
In this randomized clinical trial of 4 lining materials have been applied in deep caries
      teeth in stepwise excavation. The common material which is applied as a liner over the
      remained caries in SE is Calcium Hydroxide(CH). There are several reports of the solubility
      of this liner over time which could interact with sealing of the cavity in long term. It
      seems that a material with antibacterial activity, good sealing ability and suitable
      mechanical properties could cause SE be done efficiently with good prognosis.

      MTA is a biomaterial that has been introduced since 1993 with antibacterial property and good
      sealing ability. A New Endodontic Cement, Calcium Enriched Mixture (CEM) cement with good
      antibacterial effect like CH with sealing ability that is proposed to be similar to MTA
      according to its double sealing property. CEM cement has been suggested as a suitable
      material in pulp capping of permanent molars with irreversible pulpitis.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Pulpal Vitality
time frame: One year
description: Clinical symptoms, radiographic evaluation. Sensitivity to cold, hot, pressure, percussion.
arm group label: Control
arm group type: Experimental
description: No lining applied in group1.
arm group label: CEM cement
arm group type: Experimental
description: CEM cement applied over remained caries in group4.
arm group label: Mineral Trioxide Aggregate (MTA)
arm group type: Experimental
description: MTA applied over remained caries in group3.
arm group label: Calcium Hydroxide
arm group type: Experimental
description: Calcium Hydroxide applied over remained caries in group2.
intervention type: Drug
intervention name: Control
description: The teeth in this group restored only by filling material,without liner application.
arm group label: Control
other name: NO liner applied.
intervention type: Drug
intervention name: Calcium Hydroxide
description: Calcium Hydroxide paste applied.
arm group label: Calcium Hydroxide
other name: Calcium Hydroxide paste , Dycal,Dentsply.
intervention type: Drug
intervention name: Mineral Trioxide Aggregate(MTA)
description: MTA applied .
arm group label: Mineral Trioxide Aggregate (MTA)
other name: MTA, white MTA, ProRoot,Dentsply.
intervention type: Drug
intervention name: CEM cement
description: CEM cement applied .
arm group label: CEM cement
other name: CEM cement, Yektazist,Iran.
criteria: 
gender: All
minimum age: 18 Years
maximum age: 45 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Sepideh Banava, Assist-Prof
role: Study Chair
affiliation: Azad University of Medical Sciences, Dental Branch - Endodontics research center , SBMU
last name: Sepideh Banava, Assist-prof
phone: 982188882321
email: sbanava@yahoo.com
last name: Mohammad Safaie Yazdi, Dentist
phone: 00989123614034
email: mohammad.safaei@yahoo.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: Iran, Islamic Republic of
responsible party type: Principal Investigator
investigator affiliation: Azad University of Medical Sciences
investigator full name: Sepideh Banava.DDS,MS
investigator title: Assist-Prof
mesh term: Dental Pulp Necrosis
mesh term: Necrosis
mesh term: Calcium, Dietary
mesh term: Calcium
submitted: May 15, 2016
submission canceled: Unknown