<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/NCT03284697</url>
  </required_header>
  <id_info>
    <org_study_id>Komal Suhag</org_study_id>
    <nct_id>NCT03284697</nct_id>
  </id_info>
  <brief_title>Direct Pulp Capping With MTA and Calcium Hydroxide.</brief_title>
  <official_title>Success of Direct Pulp Capping With Mineral Trioxide Aggregate and Calcium Hydroxide In Cariously Exposed Teeth: A Randomized Clinical Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Postgraduate Institute of Dental Sciences Rohtak</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Postgraduate Institute of Dental Sciences Rohtak</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>
      Aim of the study was to evaluate and compare clinical and radiographic success with MTA and&#xD;
      calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.&#xD;
&#xD;
      Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of&#xD;
      Conservative Dentistry &amp; Endodontics. Mature permanent mandibular molars with reversible&#xD;
      pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the&#xD;
      study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly&#xD;
      allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective&#xD;
      allocated material and then tooth in both groups were restored according to standard&#xD;
      protocol.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      AIM AND OBJECTIVES The present study aims to&#xD;
&#xD;
        1. Evaluate the success of direct pulp capping in mandibular molar teeth.&#xD;
&#xD;
        2. Evaluate and compare the clinical and radiographic success with MTA and calcium&#xD;
           hydroxide as direct pulp capping materials.&#xD;
&#xD;
        3. To assess the pain intensity before and after the direct pulp capping with visual analog&#xD;
           scale (VAS).&#xD;
&#xD;
      MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department&#xD;
      of conservative dentistry and endodontics, PGIDS, Rohtak.&#xD;
&#xD;
      METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried&#xD;
      out.&#xD;
&#xD;
      A thorough history will be taken from each patient. Prior informed consent was obtained&#xD;
      either from the patient or guardians after explaining the procedure, risks and benefits.&#xD;
&#xD;
      Clinical procedure:&#xD;
&#xD;
      Mature mandibular permanent molars exhibiting deep caries approaching pulp were chosen for&#xD;
      the study.&#xD;
&#xD;
      The teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and&#xD;
      vitality assessment with thermal test and electric pulp test; the teeth determined to have&#xD;
      reversible pulpitis were included.&#xD;
&#xD;
      All periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP,&#xD;
      8 mA, and 0.8 sec.) with a Rinn paralleling device and processed manually.&#xD;
&#xD;
      After administration of local anesthesia, rubber dam isolation of the involved tooth was&#xD;
      done.&#xD;
&#xD;
      The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol.&#xD;
&#xD;
      Initially caries was removed with round bur under sterile water spray. Then, the remaining&#xD;
      caries was removed carefully with a spoon excavator. After complete caries excavation,&#xD;
      disinfection of exposed pulp with 2.5% sodium hypochlorite irrigation and a soaked cotton&#xD;
      pellet was done.&#xD;
&#xD;
      Then sodium hypochlorite dressing was placed for 10 minutes to achieve adequate pulpal&#xD;
      hemostasis.&#xD;
&#xD;
      Patients were randomly allocated into two groups (Group I - MTA and Group II -Calcium&#xD;
      hydroxide) using a computer program This study was a double blinded trial i.e. both the&#xD;
      patient and the investigator were not aware of the group to which the participant belongs.&#xD;
&#xD;
      GROUP I- CALCIUM HYDROXIDE GROUP Calcium hydroxide powder was mixed according to&#xD;
      manufacturer's instructions and applied directly onto the exposed pulps.&#xD;
&#xD;
      The cavities were then restored with resin modified GIC liner followed by composite&#xD;
      restoration.&#xD;
&#xD;
      GROUP II - MTA GROUP MTA was mixed according to manufacturer's instructions i.e. 1:3 water/&#xD;
      powder ratio and applied to exposure site with a sterile carrier.&#xD;
&#xD;
      Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed&#xD;
      temporarily with intermediate restoration material.&#xD;
&#xD;
      After 24 hours, the patient was recalled and the setting of MTA was confirmed and the cavity&#xD;
      was restored with resin modified GIC liner followed by composite restoration.&#xD;
&#xD;
      FOLLOW UP The patients were recalled periodically at 1 week, 3 months, 6 months and 12 months&#xD;
      after the direct pulp capping procedure for clinical (post operative sensitivity, pain,&#xD;
      tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical&#xD;
      radiolucency) evaluation.&#xD;
&#xD;
      CRITERIA FOR SUCCESSFUL OUTCOME A positive vitality test. No pain on percussion. No widening&#xD;
      of periodontal ligament on periapical radiograph. No clinical or radiographic signs and/or&#xD;
      symptoms of irreversible pulpitis and pulp necrosis.&#xD;
&#xD;
      CRITERIA FOR FAILURE No response to pulp vitality test. Teeth exhibiting clinical or&#xD;
      radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.&#xD;
&#xD;
      Postoperative pain assessment:&#xD;
&#xD;
      This was done using Horizontal VAS scale preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6,&#xD;
      and 7 days after the procedure.&#xD;
&#xD;
      The pain VAS was completed by the patients themselves. The patients were asked to place a&#xD;
      line perpendicular to the VAS line at the point that represents their pain intensity.&#xD;
&#xD;
      Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity&#xD;
      of pain experienced by them and note down the details of analgesic intake on the proforma&#xD;
      regarding the number of doses required and timing of the dose.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 14, 2016</start_date>
  <completion_date type="Actual">November 30, 2017</completion_date>
  <primary_completion_date type="Actual">November 30, 2017</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.</measure>
    <time_frame>Baseline to 1 year</time_frame>
    <description>CRITERIA FOR SUCCESSFUL OUTCOME&#xD;
A positive vitality test.&#xD;
No pain on percussion.&#xD;
No widening of periodontal ligament on periapical radiograph.&#xD;
No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.&#xD;
CRITERIA FOR FAILURE&#xD;
No response to pulp vitality test.&#xD;
Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).</measure>
    <time_frame>Baseline to 7 days</time_frame>
    <description>Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure.&#xD;
Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm).&#xD;
Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Reversible Pulpitis</condition>
  <arm_group>
    <arm_group_label>DPC with Ca(OH)2</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Direct pulp capping with Ca(OH)2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>DPC with MTA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Direct pulp capping with MTA</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Pulp Capping with Ca(OH)2</intervention_name>
    <description>Calcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration.</description>
    <arm_group_label>DPC with Ca(OH)2</arm_group_label>
    <other_name>Vital Pulp Therapy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Direct Pulp Capping With MTA</intervention_name>
    <description>MTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration.</description>
    <arm_group_label>DPC with MTA</arm_group_label>
    <other_name>Vital pulp therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient willing to participate in the study.&#xD;
&#xD;
          -  Age group- 15-40 years.&#xD;
&#xD;
          -  Mature permanent mandibular molars with reversible pulpitis.&#xD;
&#xD;
          -  Teeth exhibiting occlusal pulp exposure from primary dental caries.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary teeth.&#xD;
&#xD;
          -  Teeth with irreversible pulpitis (spontaneous pain) or pulp necrosis, chronic&#xD;
             periodontitis, cracked tooth, internal or external resorption, calcified canals,&#xD;
             associated with sinus tract, and furcation or apical radiolucency.&#xD;
&#xD;
          -  Immuno-compromised, diabetic, pregnant and hypertensive patients.&#xD;
&#xD;
          -  Positive history of antibiotic and analgesic use within past one month of the&#xD;
             treatment.&#xD;
&#xD;
          -  Failure to obtain authorization from patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>40 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2018</verification_date>
  <study_first_submitted>September 8, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 15, 2017</study_first_posted>
  <last_update_submitted>January 11, 2018</last_update_submitted>
  <last_update_submitted_qc>January 11, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">January 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Postgraduate Institute of Dental Sciences Rohtak</investigator_affiliation>
    <investigator_full_name>Sanjay Tewari</investigator_full_name>
    <investigator_title>Principal</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulpitis</mesh_term>
  </condition_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/NCT03284697
org study id: Komal Suhag
nct id: NCT03284697
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim of the study was to evaluate and compare clinical and radiographic success with MTA and
      calcium hydroxide as direct pulp capping materials in cariously exposed mandibular molars.

      Study was conducted in Post Graduate Institute of Dental Sciences, Rohtak in department of
      Conservative Dentistry & Endodontics. Mature permanent mandibular molars with reversible
      pulpitis exhibiting occlusal pulp exposure from primary dental caries were included in the
      study. After excavation of caries and obtaining pulpal hemostasis, patients were randomly
      allocated into two groups- MTA and Calcium Hydroxide. Pulp was capped with respective
      allocated material and then tooth in both groups were restored according to standard
      protocol.
AIM AND OBJECTIVES The present study aims to

        1. Evaluate the success of direct pulp capping in mandibular molar teeth.

        2. Evaluate and compare the clinical and radiographic success with MTA and calcium
           hydroxide as direct pulp capping materials.

        3. To assess the pain intensity before and after the direct pulp capping with visual analog
           scale (VAS).

      MATERIALS AND METHODS Study subjects were recruited from the patients visiting the Department
      of conservative dentistry and endodontics, PGIDS, Rohtak.

      METHODOLOGY Prior to treatment, a thorough clinical and radiological examination was carried
      out.

      A thorough history will be taken from each patient. Prior informed consent was obtained
      either from the patient or guardians after explaining the procedure, risks and benefits.

      Clinical procedure:

      Mature mandibular permanent molars exhibiting deep caries approaching pulp were chosen for
      the study.

      The teeth were evaluated by periapical radiographs, periodontal probing, percussion test, and
      vitality assessment with thermal test and electric pulp test; the teeth determined to have
      reversible pulpitis were included.

      All periapical radiographs were exposed by using constant kVP, mA, and exposure time (70 KVP,
      8 mA, and 0.8 sec.) with a Rinn paralleling device and processed manually.

      After administration of local anesthesia, rubber dam isolation of the involved tooth was
      done.

      The tooth was disinfected by scrubbing with 2% chlorhexidine and 75% isopropyl alcohol.

      Initially caries was removed with round bur under sterile water spray. Then, the remaining
      caries was removed carefully with a spoon excavator. After complete caries excavation,
      disinfection of exposed pulp with 2.5% sodium hypochlorite irrigation and a soaked cotton
      pellet was done.

      Then sodium hypochlorite dressing was placed for 10 minutes to achieve adequate pulpal
      hemostasis.

      Patients were randomly allocated into two groups (Group I - MTA and Group II -Calcium
      hydroxide) using a computer program This study was a double blinded trial i.e. both the
      patient and the investigator were not aware of the group to which the participant belongs.

      GROUP I- CALCIUM HYDROXIDE GROUP Calcium hydroxide powder was mixed according to
      manufacturer's instructions and applied directly onto the exposed pulps.

      The cavities were then restored with resin modified GIC liner followed by composite
      restoration.

      GROUP II - MTA GROUP MTA was mixed according to manufacturer's instructions i.e. 1:3 water/
      powder ratio and applied to exposure site with a sterile carrier.

      Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed
      temporarily with intermediate restoration material.

      After 24 hours, the patient was recalled and the setting of MTA was confirmed and the cavity
      was restored with resin modified GIC liner followed by composite restoration.

      FOLLOW UP The patients were recalled periodically at 1 week, 3 months, 6 months and 12 months
      after the direct pulp capping procedure for clinical (post operative sensitivity, pain,
      tenderness, vitality) and radiographic (widening of periodontal ligament space and periapical
      radiolucency) evaluation.

      CRITERIA FOR SUCCESSFUL OUTCOME A positive vitality test. No pain on percussion. No widening
      of periodontal ligament on periapical radiograph. No clinical or radiographic signs and/or
      symptoms of irreversible pulpitis and pulp necrosis.

      CRITERIA FOR FAILURE No response to pulp vitality test. Teeth exhibiting clinical or
      radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.

      Postoperative pain assessment:

      This was done using Horizontal VAS scale preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6,
      and 7 days after the procedure.

      The pain VAS was completed by the patients themselves. The patients were asked to place a
      line perpendicular to the VAS line at the point that represents their pain intensity.

      Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity
      of pain experienced by them and note down the details of analgesic intake on the proforma
      regarding the number of doses required and timing of the dose.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Evaluate and compare the clinical and radiographic success with MTA and calcium hydroxide as direct pulp capping materials.
time frame: Baseline to 1 year
description: CRITERIA FOR SUCCESSFUL OUTCOME
A positive vitality test.
No pain on percussion.
No widening of periodontal ligament on periapical radiograph.
No clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.
CRITERIA FOR FAILURE
No response to pulp vitality test.
Teeth exhibiting clinical or radiographic signs and/or symptoms of irreversible pulpitis and pulp necrosis.
measure: To assess the pain intensity before and after the direct pulp capping with visual analog scale (VAS).
time frame: Baseline to 7 days
description: Patients were instructed to score the pain experienced by them using VAS scale. Pain was recorded preoperatively, 6, 12, 18 hours, 1, 2, 3, 4, 5, 6, and 7 days following the procedure.
Pain intensity was categorized as: no pain (0 - 4 mm), mild pain (5- 44), moderate pain (45-74 mm), and severe pain (75- 100 mm).
Patients were also asked to take analgesic (ibuprofen 400 mg/6-8h) according to the intensity of pain experienced by them and note down the details of analgesic intake on the proforma regarding the number of doses required and timing of the dose.
arm group label: DPC with Ca(OH)2
arm group type: Active Comparator
description: Direct pulp capping with Ca(OH)2.
arm group label: DPC with MTA
arm group type: Active Comparator
description: Direct pulp capping with MTA
intervention type: Procedure
intervention name: Direct Pulp Capping with Ca(OH)2
description: Calcium hydroxide powder was mixed with saline and placed over the exposed pulp tissue. The cavities were then restored with resin modified GIC liner followed by composite restoration.
arm group label: DPC with Ca(OH)2
other name: Vital Pulp Therapy
intervention type: Procedure
intervention name: Direct Pulp Capping With MTA
description: MTA was mixed using1:3 water/ powder ratio and applied to exposure site. Then cotton pellets soaked in normal saline was placed over MTA and cavity was sealed provisionally with IRM. After 24 hours, the patient was recalled and the cavity was restored with resin modified GIC liner followed by composite restoration.
arm group label: DPC with MTA
other name: Vital pulp therapy
criteria: 
gender: All
minimum age: 15 Years
maximum age: 40 Years
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Postgraduate Institute of Dental Sciences Rohtak
investigator full name: Sanjay Tewari
investigator title: Principal
mesh term: Pulpitis
sharing ipd: No