<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/NCT01680289</url>
  </required_header>
  <id_info>
    <org_study_id>Adhesive1</org_study_id>
    <secondary_id>PRIMEBOND21</secondary_id>
    <nct_id>NCT01680289</nct_id>
  </id_info>
  <brief_title>Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Restorations in Primary Molars</brief_title>
  <official_title>Influence of the Number of Layers of a One Bottle Adhesive on the Longevity of Composite Resin Restorations in Primary Molars - Randomized Controlled Clinical Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal do Rio de Janeiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Federal do Rio de Janeiro</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to determinate the influence of an alternative adhesive application&#xD;
      protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in&#xD;
      primary molars.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adhesive systems based on total etch technique remains the most popular products among dental&#xD;
      practitioners. These systems are based on the use of an acid conditioner to remove the smear&#xD;
      layer and demineralize the enamel and dentin. After the removal of the conditioner by&#xD;
      rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is&#xD;
      applicated over the demineralized tissues. The polymerization of the adhesive monomers into&#xD;
      microporosities created by acid conditioning forms the structure knowing as hybrid layer or&#xD;
      resin-dentin interdifusion zone. A common problem related to total etch technique is the&#xD;
      incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the&#xD;
      presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to&#xD;
      enzymatic degradation. According to some laboratory studies, consecutive application of&#xD;
      multiple adhesive coats results in quantitative and qualitative improvements in dental&#xD;
      adhesion. In addition to increasing the values of bond strength to dentin, consecutive&#xD;
      application of multiple adhesive layers enhances the infiltration of adehesive monomers&#xD;
      through demineralized dentin, resulting in a more homogenous hybrid layer.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>August 2012</start_date>
  <completion_date type="Anticipated">August 2015</completion_date>
  <primary_completion_date type="Anticipated">August 2015</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Survival rate</measure>
    <time_frame>06, 12, 18, 24, 30 and 36 months</time_frame>
    <description>Survival rate considering failure of restorations due: partial or complete loss of restorative material; marginal ditching; superficial or marginal discoloration; secondary caries; pulpal complications; wear of restorative material; tooth fracture.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal adaptation</measure>
    <time_frame>06, 12, 18, 24, 30 and 36 months</time_frame>
    <description>Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">60</enrollment>
  <condition>Dental Caries</condition>
  <condition>Secondary Dental Caries</condition>
  <arm_group>
    <arm_group_label>Three adhesive coats</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Consecutive application of three one-bottle adhesive coats</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Two adhesive coats</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Consecutive application of two one-bottle adhesive coats</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Three adhesive coats</intervention_name>
    <description>After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime &amp; Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after a similar period a third layer will be applied over cavity walls. Again, after 20 seconds, the layers will be gently air-dried and photopolymerized by 10 seconds with a LED photoactivation unit.</description>
    <arm_group_label>Two adhesive coats</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Two adhesive coats</intervention_name>
    <description>After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime &amp; Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after 20 seconds, the layers will be gently air-dried by 5 seconds. The two layers will be photopolymerized by 10 seconds with a LED photoactivation unit.</description>
    <arm_group_label>Three adhesive coats</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presence of two or more pairs of caries lesions in occlusal or occluso-approximal&#xD;
             surfaces of primary molars&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic diseases in which dental treatment is a risk to patient's life&#xD;
&#xD;
          -  Bruxism&#xD;
&#xD;
          -  Orthodontic appliance&#xD;
&#xD;
          -  Absence of occlusal contact in eligible teeth&#xD;
&#xD;
          -  Signs and symptoms of pulp infflamation or necrosis&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marlus RR Cajazeira, MsD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Lucianne Cople Maia, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal do Rio de Janeiro</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Eduardo M da Silva, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Federal Fluminense</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Alessandro D Loguércio, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Universidade Estadual de Ponta Grossa</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Michelle M Amari, MsD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal Fluminense</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marlus R Cajazeira, MsC</last_name>
    <phone>55-21-8383-2492</phone>
    <email>marlus.cajazeira@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Lucianne Cople Maia, PhD</last_name>
    <phone>55-9994-3131</phone>
    <email>rorefa@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>School of Dentistry of Federal University of Rio de Janeiro</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-617</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Lucianne Cople Maia, PHD</last_name>
      <phone>55-21-9994-3131</phone>
      <email>rorefa@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Marlus Cajazeira, MSC</last_name>
      <phone>55-21-8383-2492</phone>
      <email>marlus.cajazeira@gmail.com</email>
    </contact_backup>
    <investigator>
      <last_name>Marlus RR Cajazeira, MSC</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lucianne Cople Maia, PHD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <link>
    <url>http://www.odontologia.ufrj.br</url>
    <description>School of Dentistry of Federal University of Rio de Janeiro web site</description>
  </link>
  <reference>
    <citation>Hashimoto M, Sano H, Yoshida E, Hori M, Kaga M, Oguchi H, Pashley DH. Effects of multiple adhesive coatings on dentin bonding. Oper Dent. 2004 Jul-Aug;29(4):416-23.</citation>
    <PMID>15279481</PMID>
  </reference>
  <reference>
    <citation>Hashimoto M, De Munck J, Ito S, Sano H, Kaga M, Oguchi H, Van Meerbeek B, Pashley DH. In vitro effect of nanoleakage expression on resin-dentin bond strengths analyzed by microtensile bond test, SEM/EDX and TEM. Biomaterials. 2004 Nov;25(25):5565-74. doi: 10.1016/j.biomaterials.2004.01.009.</citation>
    <PMID>15159072</PMID>
  </reference>
  <reference>
    <citation>Hashimoto M. A review--micromorphological evidence of degradation in resin-dentin bonds and potential preventional solutions. J Biomed Mater Res B Appl Biomater. 2010 Jan;92(1):268-80. doi: 10.1002/jbm.b.31535.</citation>
    <PMID>19904824</PMID>
  </reference>
  <reference>
    <citation>Pashley DH, Tay FR, Yiu C, Hashimoto M, Breschi L, Carvalho RM, Ito S. Collagen degradation by host-derived enzymes during aging. J Dent Res. 2004 Mar;83(3):216-21. doi: 10.1177/154405910408300306.</citation>
    <PMID>14981122</PMID>
  </reference>
  <reference>
    <citation>Hashimoto M, Ohno H, Kaga M, Sano H, Endo K, Oguchi H. The extent to which resin can infiltrate dentin by acetone-based adhesives. J Dent Res. 2002 Jan;81(1):74-8. doi: 10.1177/002203450208100116.</citation>
    <PMID>11820372</PMID>
  </reference>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>August 29, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 7, 2012</study_first_posted>
  <last_update_submitted>November 25, 2014</last_update_submitted>
  <last_update_submitted_qc>November 25, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Federal do Rio de Janeiro</investigator_affiliation>
    <investigator_full_name>Marlus Roberto Rodrigues Cajazeira</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Dentin bonding agents</keyword>
  <keyword>Composite restorations</keyword>
  <keyword>Dental restoration failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</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/NCT01680289
org study id: Adhesive1
secondary id: PRIMEBOND21
nct id: NCT01680289
lead sponsor: 
has dmc: No
The aim of this study is to determinate the influence of an alternative adhesive application
      protocol (i.e. consecutive application of an extra adhesive layer)on restoration longevity in
      primary molars.
Adhesive systems based on total etch technique remains the most popular products among dental
      practitioners. These systems are based on the use of an acid conditioner to remove the smear
      layer and demineralize the enamel and dentin. After the removal of the conditioner by
      rinsing, a mixture containing the primer and adhesive - i.e. one bottle adhesives - is
      applicated over the demineralized tissues. The polymerization of the adhesive monomers into
      microporosities created by acid conditioning forms the structure knowing as hybrid layer or
      resin-dentin interdifusion zone. A common problem related to total etch technique is the
      incomplete infiltration of adhesive monomers through demineralized dentin, resulting in the
      presence of a zone of unprotected collagen fibrils beneath the hybrid layer that is prone to
      enzymatic degradation. According to some laboratory studies, consecutive application of
      multiple adhesive coats results in quantitative and qualitative improvements in dental
      adhesion. In addition to increasing the values of bond strength to dentin, consecutive
      application of multiple adhesive layers enhances the infiltration of adehesive monomers
      through demineralized dentin, resulting in a more homogenous hybrid layer.
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Survival rate
time frame: 06, 12, 18, 24, 30 and 36 months
description: Survival rate considering failure of restorations due: partial or complete loss of restorative material; marginal ditching; superficial or marginal discoloration; secondary caries; pulpal complications; wear of restorative material; tooth fracture.
measure: Marginal adaptation
time frame: 06, 12, 18, 24, 30 and 36 months
description: Evaluation of resin replicas of restored teeth on scanning electron microscopy (SEM)
arm group label: Three adhesive coats
arm group type: Experimental
description: Consecutive application of three one-bottle adhesive coats
arm group label: Two adhesive coats
arm group type: Active Comparator
description: Consecutive application of two one-bottle adhesive coats
intervention type: Procedure
intervention name: Three adhesive coats
description: After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after a similar period a third layer will be applied over cavity walls. Again, after 20 seconds, the layers will be gently air-dried and photopolymerized by 10 seconds with a LED photoactivation unit.
arm group label: Two adhesive coats
intervention type: Procedure
intervention name: Two adhesive coats
description: After caries removal, enamel margins will be conditioned with phosphoric acid gel 37% by 15 seconds and dentin walls by 8 seconds. The etchant will be removed with use of water spray by 30 seconds. The water excess will be removed with a cotton pellet. The first layer of Prime & Bond 2.1 adhesive will be applied with a microbrush. After 20 seconds a second layer will be applied and after 20 seconds, the layers will be gently air-dried by 5 seconds. The two layers will be photopolymerized by 10 seconds with a LED photoactivation unit.
arm group label: Three adhesive coats
criteria: 
gender: All
minimum age: 5 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Marlus RR Cajazeira, MsD
role: Principal Investigator
affiliation: Universidade Federal do Rio de Janeiro
last name: Lucianne Cople Maia, PhD
role: Study Chair
affiliation: Universidade Federal do Rio de Janeiro
last name: Eduardo M da Silva, PhD
role: Study Chair
affiliation: Universidade Federal Fluminense
last name: Alessandro D Loguércio, PhD
role: Study Chair
affiliation: Universidade Estadual de Ponta Grossa
last name: Michelle M Amari, MsD
role: Study Director
affiliation: Universidade Federal Fluminense
last name: Marlus R Cajazeira, MsC
phone: 55-21-8383-2492
email: marlus.cajazeira@gmail.com
last name: Lucianne Cople Maia, PhD
phone: 55-9994-3131
email: rorefa@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
url: http://www.odontologia.ufrj.br
description: School of Dentistry of Federal University of Rio de Janeiro web site
citation: Hashimoto M, Sano H, Yoshida E, Hori M, Kaga M, Oguchi H, Pashley DH. Effects of multiple adhesive coatings on dentin bonding. Oper Dent. 2004 Jul-Aug;29(4):416-23.
PMID: 15279481
citation: Hashimoto M, De Munck J, Ito S, Sano H, Kaga M, Oguchi H, Van Meerbeek B, Pashley DH. In vitro effect of nanoleakage expression on resin-dentin bond strengths analyzed by microtensile bond test, SEM/EDX and TEM. Biomaterials. 2004 Nov;25(25):5565-74. doi: 10.1016/j.biomaterials.2004.01.009.
PMID: 15159072
citation: Hashimoto M. A review--micromorphological evidence of degradation in resin-dentin bonds and potential preventional solutions. J Biomed Mater Res B Appl Biomater. 2010 Jan;92(1):268-80. doi: 10.1002/jbm.b.31535.
PMID: 19904824
citation: Pashley DH, Tay FR, Yiu C, Hashimoto M, Breschi L, Carvalho RM, Ito S. Collagen degradation by host-derived enzymes during aging. J Dent Res. 2004 Mar;83(3):216-21. doi: 10.1177/154405910408300306.
PMID: 14981122
citation: Hashimoto M, Ohno H, Kaga M, Sano H, Endo K, Oguchi H. The extent to which resin can infiltrate dentin by acetone-based adhesives. J Dent Res. 2002 Jan;81(1):74-8. doi: 10.1177/002203450208100116.
PMID: 11820372
responsible party type: Principal Investigator
investigator affiliation: Universidade Federal do Rio de Janeiro
investigator full name: Marlus Roberto Rodrigues Cajazeira
investigator title: Assistant Professor
mesh term: Dental Caries