<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/NCT03826810</url>
  </required_header>
  <id_info>
    <org_study_id>Leticia</org_study_id>
    <nct_id>NCT03826810</nct_id>
  </id_info>
  <brief_title>Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH</brief_title>
  <official_title>Effect of Low-intensity Laser and Photodynamic Therapy on Infected Dentin of Permanent Teeth With MIH - Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Nove de Julho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Nove de Julho</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>
      The objective of this research was to evaluate the clinical effect of photodynamic therapy on&#xD;
      dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization&#xD;
      (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection&#xD;
      of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The&#xD;
      selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity,&#xD;
      indicated for clinical restorative treatment. Photodynamic therapy was applied with the use&#xD;
      of low-intensity laser in permanent teeth selected for the treatment of infected dentin in&#xD;
      G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative&#xD;
      treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high&#xD;
      viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a&#xD;
      time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis.&#xD;
      For the evaluation of the association of categorical variables like age and gender, the&#xD;
      Chi-square test and Fisher's exact test were used. To analyze the correlation between the&#xD;
      continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were&#xD;
      applied for the analysis of dentin density in the radiographic images scanned and the&#xD;
      microbiological results for colony forming units.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">December 30, 2018</completion_date>
  <primary_completion_date type="Actual">November 30, 2018</primary_completion_date>
  <phase>Phase 1</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>Single (Outcomes Assessor)</masking>
    <masking_description>Clinical evaluations of complete removal of caries lesion, microbiological and radiographic analysis were made by two blind examiners, who did not know to which group the participants belonged.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dentin sensitivity</measure>
    <time_frame>Before and immediately after treatment.</time_frame>
    <description>Prior to removal of carious tissue, the volunteers responded to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS was repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in colony forming units</measure>
    <time_frame>Before and immediately after treatment.</time_frame>
    <description>Microbiological specimens were collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in dentin density</measure>
    <time_frame>After 6 and 12 months.</time_frame>
    <description>The objective was to quantitatively determine the gray tones of the affected dentin region just below the glass ionomer restoration, whose radiographic control for visualization of the healthy dentin allows the clinical evaluator of the study to compare the treated groups with the density of the remaining dentin in discussion. The statistical analysis of the optical density were made according to the mixed effects model.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the presence of cavity filling</measure>
    <time_frame>After 6 and 12 months.</time_frame>
    <description>The evaluation scores will be evaluated based on the results of studies by other authors (Frencken, et al., 1996). Digital photos (Canon Sx500 IS Camera) will be taken of all the teeth and, from these photographs, the teeth will be classified as follows:&#xD;
0 = present, without defect.&#xD;
= present, small defects in the margin less than 0.5 mm deep, no need for repair.&#xD;
= present, small defects in the margin of 0.5 to 1 mm depth, needs repair.&#xD;
= present, gross defects in the margin of 1 mm or more in depth, needs repair.&#xD;
= absent, restoration almost / completely lost, needs treatment.&#xD;
= absent, other treatment was performed for any other reason.&#xD;
= tooth missing due to any reason.&#xD;
= present, surface wear less than 0.5 mm, no need for replacement.&#xD;
= present, surface wear greater than 0.5 mm, need replacement.&#xD;
= impossible to diagnose.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">48</enrollment>
  <condition>Molar Incisor Hypomineralization</condition>
  <arm_group>
    <arm_group_label>aPDT + ART group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, both aPDT and ART were performed.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ART group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this group, only ART was performed.</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>aPDT</intervention_name>
    <description>For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.</description>
    <arm_group_label>aPDT + ART group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>ART</intervention_name>
    <description>Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.</description>
    <arm_group_label>ART group</arm_group_label>
    <arm_group_label>aPDT + ART group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Healthy children, without systemic alterations;&#xD;
&#xD;
          -  Collaborative children;&#xD;
&#xD;
          -  Present at least one permanent molar with active and acute caries lesion in dentin,&#xD;
             not exceeding 2/3 and involving only the occlusal, with direct vision and access,&#xD;
             without clinical and radiographic signs and symptoms of pulp involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Child with systemic impairment;&#xD;
&#xD;
          -  Non-cooperative behavior;&#xD;
&#xD;
          -  Carious lesion of Class II, III, IV or V type of Black;&#xD;
&#xD;
          -  Clinically: carious lesion involving enamel, deficient restorations, small carious&#xD;
             lesions in dentin (without access to hand excavators), occult caries lesions, clinical&#xD;
             sign and/or symptom of pulp involvement, clinical impossibility of restoration;&#xD;
&#xD;
          -  Radiographically: evidence of pulpal involvement, carious lesion extending beyond 2/3&#xD;
             of the dentin.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>12 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Faculdades Integradas Da União Educacional Do Planalto Central</name>
      <address>
        <city>Gama</city>
        <state>DF</state>
        <zip>72445-020</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>January 30, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 1, 2019</study_first_posted>
  <last_update_submitted>March 20, 2019</last_update_submitted>
  <last_update_submitted_qc>March 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Nove de Julho</investigator_affiliation>
    <investigator_full_name>Sandra Kalil Bussadori</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molar Hypomineralization</mesh_term>
  </condition_browse>
  <!-- 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/NCT03826810
org study id: Leticia
nct id: NCT03826810
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The objective of this research was to evaluate the clinical effect of photodynamic therapy on
      dentin infected by caries lesion in permanent teeth with Molar Incisor Hypomineralization
      (MIH). The study was composed of Groups (1 and 2). The methodology was based on the selection
      of patients from 6 to 12 years of age with permanent molar teeth, randomly divided. The
      selected teeth had deep dentin caries lesions on the occlusal surface, and sensitivity,
      indicated for clinical restorative treatment. Photodynamic therapy was applied with the use
      of low-intensity laser in permanent teeth selected for the treatment of infected dentin in
      G1. In this group, antimicrobial photodynamic therapy (aPDT) and atraumatic restorative
      treatment (ART) were made. In G2, only ART was performed. The teeth were restored with high
      viscosity glass ionomer cement. All patients had clinical and radiographic follow-up with a
      time interval of 6 and 12 months. Data were submitted to descriptive statistical analysis.
      For the evaluation of the association of categorical variables like age and gender, the
      Chi-square test and Fisher's exact test were used. To analyze the correlation between the
      continuous variables, the Pearson correlation test was applied. ANOVA and Kruskal-Wallis were
      applied for the analysis of dentin density in the radiographic images scanned and the
      microbiological results for colony forming units.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Clinical evaluations of complete removal of caries lesion, microbiological and radiographic analysis were made by two blind examiners, who did not know to which group the participants belonged.
measure: Change in dentin sensitivity
time frame: Before and immediately after treatment.
description: Prior to removal of carious tissue, the volunteers responded to the Visual Analogue Scale (VAS), following this protocol: gauze isolation of neighboring teeth and air jet in the tooth with MIH for 3 to 5 seconds. The evaluation of the sensitivity through the VAS was repeated at the end of the procedure, after Atraumatic Restorative Treatment (ART).
measure: Change in colony forming units
time frame: Before and immediately after treatment.
description: Microbiological specimens were collected from the surface of the dentin before and immediately after the treatment, for later counting of colony forming units.
measure: Change in dentin density
time frame: After 6 and 12 months.
description: The objective was to quantitatively determine the gray tones of the affected dentin region just below the glass ionomer restoration, whose radiographic control for visualization of the healthy dentin allows the clinical evaluator of the study to compare the treated groups with the density of the remaining dentin in discussion. The statistical analysis of the optical density were made according to the mixed effects model.
measure: Change in the presence of cavity filling
time frame: After 6 and 12 months.
description: The evaluation scores will be evaluated based on the results of studies by other authors (Frencken, et al., 1996). Digital photos (Canon Sx500 IS Camera) will be taken of all the teeth and, from these photographs, the teeth will be classified as follows:
0 = present, without defect.
= present, small defects in the margin less than 0.5 mm deep, no need for repair.
= present, small defects in the margin of 0.5 to 1 mm depth, needs repair.
= present, gross defects in the margin of 1 mm or more in depth, needs repair.
= absent, restoration almost / completely lost, needs treatment.
= absent, other treatment was performed for any other reason.
= tooth missing due to any reason.
= present, surface wear less than 0.5 mm, no need for replacement.
= present, surface wear greater than 0.5 mm, need replacement.
= impossible to diagnose.
arm group label: aPDT + ART group
arm group type: Experimental
description: In this group, both aPDT and ART were performed.
arm group label: ART group
arm group type: Experimental
description: In this group, only ART was performed.
intervention type: Radiation
intervention name: aPDT
description: For the aPDT the PapacarieMblue (Fórmula e Ação) was used. It was left for 5 minutes in the cavity. The carious tissue was removed and the application of the PapacarieMblue was repeated. The tissue was then irradiated in a single spot with a red laser, of wavelength of 660 nm, for 300 s, with the energy of 500mJ. These parameters were also applied in the vestibular root of the teeth, to try and prevent sensitivity.
arm group label: aPDT + ART group
intervention type: Procedure
intervention name: ART
description: Removal of infected dentin with a curette only, followed by cavity cleaning and restoration with glass ionomer cement.
arm group label: ART group
arm group label: aPDT + ART group
criteria: 
gender: All
minimum age: 6 Years
maximum age: 12 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: University of Nove de Julho
investigator full name: Sandra Kalil Bussadori
investigator title: Principal Investigator
mesh term: Molar Hypomineralization