<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/NCT03819868</url>
  </required_header>
  <id_info>
    <org_study_id>SLM 5</org_study_id>
    <nct_id>NCT03819868</nct_id>
  </id_info>
  <brief_title>Efficacy of Sealing Molars: Split-mouth Randomized Clinical Trial</brief_title>
  <official_title>Efficacy of Resin Sealing in Deciduous and Permanent Molars: Split-mouth Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Faculty Sao Leopoldo Mandic Campinas</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Faculty Sao Leopoldo Mandic Campinas</source>
  <oversight_info>
    <has_dmc>No</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>
      The sealing of fossae and fissures is an effective procedure in preventing occlusal caries&#xD;
      lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel&#xD;
      lesions. In addition, there are no studies in the literature that have compared the longevity&#xD;
      of sealings performed with the different sealants available in the market. Thus, the&#xD;
      objective of this study is to evaluate the efficacy of fossae and fissures sealings performed&#xD;
      with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous&#xD;
      molars. This is a multicenter clinical study of non-inferiority, randomized, controlled,&#xD;
      double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of&#xD;
      children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized&#xD;
      into two groups using a distributed randomization list in mixed envelopes that will be open&#xD;
      only at the time of the procedure. The teeth allocated in the test group will be treated with&#xD;
      the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ&#xD;
      sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy&#xD;
      of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and&#xD;
      18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and&#xD;
      quality of life, will also be evaluated.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 15, 2017</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Actual">February 15, 2019</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>
    <intervention_model_description>Split-mouth</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Dental caries progression</measure>
    <time_frame>Every 6 months up to 18 months</time_frame>
    <description>Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:&#xD;
Present progression: Increased radiolucidity area of the Lesion&#xD;
Absent progression: No increase in the area of radiolucidity of the lesion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Cost-effectiveness</measure>
    <time_frame>18 months</time_frame>
    <description>The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Impact on children's quality of life</measure>
    <time_frame>Baseline and 18 months</time_frame>
    <description>The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The &quot;Early Childhood Oral Health Impact Scale&quot; (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The &quot;Child Perceptions Questionnaire&quot; (CPQ) will be used for 6-9 years old children (Martins et al., 2009).&#xD;
They will be applied immediately before the procedure and on 18 months follow-up and we will measure the difference between answers at baseline and the end of treatment (18months)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Children self-reported discomfort</measure>
    <time_frame>Baseline</time_frame>
    <description>The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences. Each face corresponds to a number, within a numeric scale from 0 to 5, with 0 no discomfort and 5 the greatest discomfort. At the end, the averages of each score will be compared between the experimental groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sealant retention</measure>
    <time_frame>Every 6 months up to 18 months</time_frame>
    <description>The elements submitted to the treatment will be codified in accordance with Hesse et al. (2012):&#xD;
Full retention: When the restorer material was Intact when subjected to clinical examination;&#xD;
Partial loss: When there was a loss of a part of the restorer material previously applied;&#xD;
Total Loss: When the restorer material has been lost in its entirety.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Dental Caries</condition>
  <arm_group>
    <arm_group_label>High Cost</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Restoration using a high-cost sealant</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low Cost</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Restoration using a low-cost sealant</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>High cost</intervention_name>
    <description>Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.</description>
    <arm_group_label>High Cost</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Low Cost</intervention_name>
    <description>Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.</description>
    <arm_group_label>Low Cost</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children with at least two deciduous and/or permanent molars with occlusal caries&#xD;
             lesions scores 1, 2 or 3 of the Icdas (Ismail et al., 2007) will be included, one on&#xD;
             each side, preferably from the same arch.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with special needs;&#xD;
&#xD;
          -  using orthodontic appliances;&#xD;
&#xD;
          -  with systemic diseases;&#xD;
&#xD;
          -  Teeth that present restorations, sealants, formation defects, deep caries lesions that&#xD;
             may lead to pulp impairment;&#xD;
&#xD;
          -  teeth with fistula and/or abscess;&#xD;
&#xD;
          -  teeth with spontaneous painful symptomatology.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jose Carlos P Imparato, PhD</last_name>
    <phone>+5511998686008</phone>
    <email>jimparato@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculty Sao Leopoldo Mandic</name>
      <address>
        <city>Campinas</city>
        <state>Sao Paulo</state>
        <zip>13045755</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jose Carlos P Imparato, PhD</last_name>
      <phone>+551935183601</phone>
      <email>jimparato@usp.br</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <results_reference>
    <citation>Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.</citation>
    <PMID>24884684</PMID>
  </results_reference>
  <results_reference>
    <citation>Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.</citation>
    <PMID>19761288</PMID>
  </results_reference>
  <results_reference>
    <citation>Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.</citation>
    <PMID>18709230</PMID>
  </results_reference>
  <results_reference>
    <citation>Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.</citation>
    <PMID>3344163</PMID>
  </results_reference>
  <results_reference>
    <citation>Pitts N, Melo P, Martignon S, Ekstrand K, Ismail A. Caries risk assessment, diagnosis and synthesis in the context of a European Core Curriculum in Cariology. Eur J Dent Educ. 2011 Nov;15 Suppl 1:23-31. doi: 10.1111/j.1600-0579.2011.00711.x.</citation>
    <PMID>22023543</PMID>
  </results_reference>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 22, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 29, 2019</study_first_posted>
  <last_update_submitted>December 9, 2019</last_update_submitted>
  <last_update_submitted_qc>December 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 10, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Faculty Sao Leopoldo Mandic Campinas</investigator_affiliation>
    <investigator_full_name>Jose Carlos P Imparato</investigator_full_name>
    <investigator_title>PhD, Senior Lecturer, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>dental caries</keyword>
  <keyword>molars</keyword>
  <keyword>Pit and Fissure Sealants</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03819868
org study id: SLM 5
nct id: NCT03819868
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The sealing of fossae and fissures is an effective procedure in preventing occlusal caries
      lesions. However, there are gaps regarding its efficacy in the treatment of initial enamel
      lesions. In addition, there are no studies in the literature that have compared the longevity
      of sealings performed with the different sealants available in the market. Thus, the
      objective of this study is to evaluate the efficacy of fossae and fissures sealings performed
      with a low-cost resinous sealant in occlusal lesions in enamel in permanent and deciduous
      molars. This is a multicenter clinical study of non-inferiority, randomized, controlled,
      double blind (patient and operator) with 60 deciduous molars and 340 permanent molars of
      children 4 and 9 years of age. The sample unit will be the tooth, which will be randomized
      into two groups using a distributed randomization list in mixed envelopes that will be open
      only at the time of the procedure. The teeth allocated in the test group will be treated with
      the sealant preventâ; Those allocated in the control group will employ the Fluroshieldâ
      sealant. In both groups the procedure will follow the manufacturer's standards. The efficacy
      of the sealant will be evaluated by means of clinical and radiographic control at 6, 12 and
      18 months after the procedure. Secondary outcomes, such as retention, cost, acceptability and
      quality of life, will also be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Split-mouth
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Dental caries progression
time frame: Every 6 months up to 18 months
description: Caries progression will be evaluated radiographically by three previously trained evaluators (through theoretical classes and evaluation of 13 clinical photographs) and calibrated. These examiners will not know the chronological order and compare the images two to two first by two evaluators and when there is disagreement between the two, the third examiner shall be called for tie-breaker. The possible progression of the treated caries lesion will be codified as:
Present progression: Increased radiolucidity area of the Lesion
Absent progression: No increase in the area of radiolucidity of the lesion.
measure: Cost-effectiveness
time frame: 18 months
description: The costs of each treatment procedure will be calculated and compared with thresholds values for intervention costeffectiveness by region, determined by World Health Organization (http://www.who.int/choice/costs/CER_levels/en/).
measure: Impact on children's quality of life
time frame: Baseline and 18 months
description: The oral health related quality of life will be measured using a validated questionnaire according to the children's age. The "Early Childhood Oral Health Impact Scale" (ECOHIS) (Tesch et al., 2008) will be applied with 4-5 years old children. The "Child Perceptions Questionnaire" (CPQ) will be used for 6-9 years old children (Martins et al., 2009).
They will be applied immediately before the procedure and on 18 months follow-up and we will measure the difference between answers at baseline and the end of treatment (18months)
measure: Children self-reported discomfort
time frame: Baseline
description: The discomfort of each treatment will be evaluated using the facial scale of Wong-Baker (Wong, Baker, 1988). The patient will be asked to choose the face that is more similar to how he/she felt during the treatment. The answer should be given solely by the child, which means no parental or professional interferences. Each face corresponds to a number, within a numeric scale from 0 to 5, with 0 no discomfort and 5 the greatest discomfort. At the end, the averages of each score will be compared between the experimental groups.
measure: Sealant retention
time frame: Every 6 months up to 18 months
description: The elements submitted to the treatment will be codified in accordance with Hesse et al. (2012):
Full retention: When the restorer material was Intact when subjected to clinical examination;
Partial loss: When there was a loss of a part of the restorer material previously applied;
Total Loss: When the restorer material has been lost in its entirety.
arm group label: High Cost
arm group type: Active Comparator
description: Restoration using a high-cost sealant
arm group label: Low Cost
arm group type: Experimental
description: Restoration using a low-cost sealant
intervention type: Procedure
intervention name: High cost
description: Surfaces allocated to this group will be treated with a high-cost sealant (Fluroshield®, Dentsply, São Paulo, Brazil), according to the manufacturer's instructions.
arm group label: High Cost
intervention type: Procedure
intervention name: Low Cost
description: Surfaces allocated to this group will be treated with a low-cost sealant (Prevent®, FGM Produtos Odontológicos, Santa Catarina, Brazil), according to the manufacturer's instructions.
arm group label: Low Cost
criteria: 
gender: All
minimum age: 4 Years
maximum age: 9 Years
healthy volunteers: No
last name: Jose Carlos P Imparato, PhD
phone: +5511998686008
email: jimparato@usp.br
facility: 
status: Recruiting
contact: 
country: Brazil
citation: Hesse D, Bonifacio CC, Mendes FM, Braga MM, Imparato JC, Raggio DP. Sealing versus partial caries removal in primary molars: a randomized clinical trial. BMC Oral Health. 2014 May 28;14:58. doi: 10.1186/1472-6831-14-58.
PMID: 24884684
citation: Martins MT, Ferreira FM, Oliveira AC, Paiva SM, Vale MP, Allison PJ, Pordeus IA. Preliminary validation of the Brazilian version of the Child Perceptions Questionnaire 8-10. Eur J Paediatr Dent. 2009 Sep;10(3):135-40.
PMID: 19761288
citation: Tesch FC, Oliveira BH, Leao A. [Semantic equivalence of the Brazilian version of the Early Childhood Oral Health Impact Scale]. Cad Saude Publica. 2008 Aug;24(8):1897-909. doi: 10.1590/s0102-311x2008000800018. Portuguese.
PMID: 18709230
citation: Wong DL, Baker CM. Pain in children: comparison of assessment scales. Pediatr Nurs. 1988 Jan-Feb;14(1):9-17. No abstract available.
PMID: 3344163
citation: Pitts N, Melo P, Martignon S, Ekstrand K, Ismail A. Caries risk assessment, diagnosis and synthesis in the context of a European Core Curriculum in Cariology. Eur J Dent Educ. 2011 Nov;15 Suppl 1:23-31. doi: 10.1111/j.1600-0579.2011.00711.x.
PMID: 22023543
responsible party type: Principal Investigator
investigator affiliation: Faculty Sao Leopoldo Mandic Campinas
investigator full name: Jose Carlos P Imparato
investigator title: PhD, Senior Lecturer, Clinical Professor
mesh term: Dental Caries
sharing ipd: Undecided