<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/NCT03244124</url>
  </required_header>
  <id_info>
    <org_study_id>UFFUEPGFUTURABOND2016</org_study_id>
    <nct_id>NCT03244124</nct_id>
  </id_info>
  <brief_title>Different Application Strategies When Using Futurabond Universal in Class V Cavities</brief_title>
  <acronym>FUUC</acronym>
  <official_title>Clinical Evaluation of Different Application Strategies When Using a Futurabond Universal Adhesive System in Class V Cavities</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Federal Fluminense</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Universidade Estadual de Ponta Grossa</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Universidade Federal Fluminense</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,&#xD;
      that aims to evaluate the best application strategy when using a new Universal Adhesive&#xD;
      system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and&#xD;
      recruited,following inclusion criteria and pre-established exclusion. All volunteers will be&#xD;
      informed and sign a term of clarification and consent. 50 enrolled patients will receive 200&#xD;
      Class V dental restorations, made in four different ways, one from each experimental group,&#xD;
      using the same universal self-etching adhesive system, which is the tested material in this&#xD;
      study. Non-carious cervical lesions will receive the applied adhesive system in 4 different&#xD;
      protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the&#xD;
      adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in&#xD;
      the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity,&#xD;
      will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode&#xD;
      (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during&#xD;
      30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity&#xD;
      will be air-dried, and then, the adhesive will be applied according to the manufacturer's&#xD;
      instructions, as described in group SET; Group ERDry (Etch&amp; Rinse Dry): 37% phosphoric acid&#xD;
      will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50&#xD;
      teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin&#xD;
      dry, and then, the adhesive will be applied according to the manufacturer's instructions, as&#xD;
      described in group SET; Group ERWet (Etch&amp; Rinse Wet): 37% phosphoric acid will be applied&#xD;
      during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This&#xD;
      acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then,&#xD;
      the adhesive will be applied according to the manufacturer's instructions, as described in&#xD;
      group SET. After applying the adhesive, the restorations will be made with composite resin,&#xD;
      and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using&#xD;
      scores. To determine in which group each tooth will be enrolled, the authors will randomize&#xD;
      the teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with&#xD;
      four groups, that aims to evaluate the best application strategy when using a new Universal&#xD;
      Adhesive system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and&#xD;
      recruited,following inclusion criteria and pre-established exclusion. All volunteers will be&#xD;
      informed and sign a term of clarification and consent. All 50 enrolled patients will receive&#xD;
      Class V dental restorations, made in four different ways, one from each experimental group,&#xD;
      using the same universal self-etching adhesive system, which is the tested material in this&#xD;
      study. All patients must have at only 20 teeth in function, must have at only 2 non carious&#xD;
      cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must be non&#xD;
      carious, must be more than 1 mm deep, should have exposed dentin, and must have at only 50%&#xD;
      of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient&#xD;
      will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with&#xD;
      pumice powder and water. All cavities will be washed and dried after these procedures for&#xD;
      optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth&#xD;
      to be restored will be held. Non-carious cervical lesions will receive the applied adhesive&#xD;
      system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no&#xD;
      conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's&#xD;
      instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds&#xD;
      in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with Light&#xD;
      Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be&#xD;
      applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water,&#xD;
      the cavity will be air-dried, and then, the adhesive will be applied according to the&#xD;
      manufacturer's instructions, as described in group SET; Group ERDry (Etch&amp; Rinse Dry): 37%&#xD;
      phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only&#xD;
      in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried,&#xD;
      keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's&#xD;
      instructions, as described in group SET; Group ERWet (Etch&amp; Rinse Wet): 37% phosphoric acid&#xD;
      will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50&#xD;
      teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin&#xD;
      wet, and then, the adhesive will be applied according to the manufacturer's instructions, as&#xD;
      described in group SET. After applying the adhesive, the restorations will be made with&#xD;
      composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain&#xD;
      assessment, shape, staining or recurrent caries, using scores. To determine in which group&#xD;
      each tooth will be enrolled, the authors will randomize the teeth.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 3, 2016</start_date>
  <completion_date type="Anticipated">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">May 31, 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>Restoration Loss</measure>
    <time_frame>Four years</time_frame>
    <description>It will be evaluated the increase in the number of losses of dental restorations in the period of four years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal Pigmentation</measure>
    <time_frame>Four years</time_frame>
    <description>It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of four years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Operative Hypersensitivity</measure>
    <time_frame>Four years</time_frame>
    <description>It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of four years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Secondary Caries</measure>
    <time_frame>Four years</time_frame>
    <description>It will be evaluated the increase in the number of dental restorations with secondary caries in the period of four years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Dental Restoration Failure of Marginal Integrity</condition>
  <arm_group>
    <arm_group_label>SET (Self-Etching)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>50 teeth will receive restorations using Self-Etching Application Strategy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SEE (Selective Enamel Etching)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 teeth will receive restorations using Enamel Etching Application Strategy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERDry (Etch&amp;Rinse Dry)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 teeth will receive restorations using Etch&amp;Rinse Dry Application Strategy, leaving dentin dry (but not overdry)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ERWet (Etch&amp;Rinse Wet)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>50 teeth will receive restorations using Etch&amp;Rinse Wet Application Strategy, leaving dentin wet</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Self-Etching Application Strategy</intervention_name>
    <description>In Group SET, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.</description>
    <arm_group_label>SET (Self-Etching)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Enamel Etching Application Strategy</intervention_name>
    <description>In Group SEE, 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.</description>
    <arm_group_label>SEE (Selective Enamel Etching)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Etch&amp;Rinse Dry Application Strategy</intervention_name>
    <description>In Group ERDry, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry (but not overdry) and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.</description>
    <arm_group_label>ERDry (Etch&amp;Rinse Dry)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Etch&amp;Rinse Wet Application Strategy</intervention_name>
    <description>In Group ERWet, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.</description>
    <arm_group_label>ERWet (Etch&amp;Rinse Wet)</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All patients must have at only 20 teeth in function, must have at only 2 non carious&#xD;
             cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must&#xD;
             be non carious, must be more than 1 mm deep, should have exposed dentin, and must have&#xD;
             at only 50% of margins in enamel. Teeth should not present periodontal mobility.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Volunteers with periodontal disease; with gingival bleeding; use of anti-inflammatory&#xD;
             drugs in the last 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>MARCOS O BARCELEIRO, DDS, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Universidade Federal Fluminense</affiliation>
  </overall_official>
  <overall_official>
    <last_name>ALESSANDRO D LOGUERCIO, DDS, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Universidade Estadual de Ponta Grossa</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Universidade Estadual de Ponta Grossa</name>
      <address>
        <city>Ponta Grossa</city>
        <state>Paraná</state>
        <zip>84010-290</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidade Federal Fluminense - School of Dentistry</name>
      <address>
        <city>Nova Friburgo</city>
        <state>RIO DE Janeiro</state>
        <zip>28625-650</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Pashley DH, Tay FR. Aggressiveness of contemporary self-etching adhesives. Part II: etching effects on unground enamel. Dent Mater. 2001 Sep;17(5):430-44. doi: 10.1016/s0109-5641(00)00104-4.</citation>
    <PMID>11445211</PMID>
  </reference>
  <reference>
    <citation>Perdigao J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26.</citation>
    <PMID>23802645</PMID>
  </reference>
  <reference>
    <citation>Erhardt MC, Cavalcante LM, Pimenta LA. Influence of phosphoric acid pretreatment on self-etching bond strengths. J Esthet Restor Dent. 2004;16(1):33-40; discussion 41. doi: 10.1111/j.1708-8240.2004.tb00448.x.</citation>
    <PMID>15259541</PMID>
  </reference>
  <reference>
    <citation>Erickson RL, Barkmeier WW, Latta MA. The role of etching in bonding to enamel: a comparison of self-etching and etch-and-rinse adhesive systems. Dent Mater. 2009 Nov;25(11):1459-67. doi: 10.1016/j.dental.2009.07.002. Epub 2009 Aug 7.</citation>
    <PMID>19665220</PMID>
  </reference>
  <reference>
    <citation>Torii Y, Itou K, Nishitani Y, Ishikawa K, Suzuki K. Effect of phosphoric acid etching prior to self-etching primer application on adhesion of resin composite to enamel and dentin. Am J Dent. 2002 Oct;15(5):305-8.</citation>
    <PMID>12537339</PMID>
  </reference>
  <reference>
    <citation>Van Landuyt KL, Peumans M, De Munck J, Lambrechts P, Van Meerbeek B. Extension of a one-step self-etch adhesive into a multi-step adhesive. Dent Mater. 2006 Jun;22(6):533-44. doi: 10.1016/j.dental.2005.05.010. Epub 2005 Nov 21.</citation>
    <PMID>16300826</PMID>
  </reference>
  <reference>
    <citation>da Costa TR, Ferri LD, Loguercio AD, Reis A. Eighteen-month randomized clinical trial on the performance of two etch-and-rinse adhesives in non-carious cervical lesions. Am J Dent. 2014 Dec;27(6):312-7.</citation>
    <PMID>25707085</PMID>
  </reference>
  <reference>
    <citation>Lopes LS, Calazans FS, Hidalgo R, Buitrago LL, Gutierrez F, Reis A, Loguercio AD, Barceleiro MO. Six-month Follow-up of Cervical Composite Restorations Placed With a New Universal Adhesive System: A Randomized Clinical Trial. Oper Dent. 2016 Sep-Oct;41(5):465-480. doi: 10.2341/15-309-C. Epub 2016 Jul 5.</citation>
    <PMID>27379834</PMID>
  </reference>
  <reference>
    <citation>Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.</citation>
    <PMID>11137632</PMID>
  </reference>
  <reference>
    <citation>Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Int Dent J. 2007 Oct;57(5):300-2. doi: 10.1111/j.1875-595x.2007.tb00136.x. No abstract available.</citation>
    <PMID>17992913</PMID>
  </reference>
  <reference>
    <citation>Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.</citation>
    <PMID>20628774</PMID>
  </reference>
  <reference>
    <citation>Dalton Bittencourt D, Ezecelevski IG, Reis A, Van Dijken JW, Loguercio AD. An 18-months' evaluation of self-etch and etch &amp; rinse adhesive in non-carious cervical lesions. Acta Odontol Scand. 2005 Jun;63(3):173-8. doi: 10.1080/00016350510019874.</citation>
    <PMID>16191912</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>August 4, 2017</study_first_submitted>
  <study_first_submitted_qc>August 4, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 9, 2017</study_first_posted>
  <last_update_submitted>October 25, 2020</last_update_submitted>
  <last_update_submitted_qc>October 25, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 27, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>dentin bonding agents</keyword>
  <keyword>tooth sensitivity</keyword>
  <keyword>composite resin restoration</keyword>
  <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/NCT03244124
org study id: UFFUEPGFUTURABOND2016
nct id: NCT03244124
lead sponsor: 
collaborator: 
has dmc: No
Treatment clinical trial, randomized, controled, parallel, double-blinded, with four groups,
      that aims to evaluate the best application strategy when using a new Universal Adhesive
      system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and
      recruited,following inclusion criteria and pre-established exclusion. All volunteers will be
      informed and sign a term of clarification and consent. 50 enrolled patients will receive 200
      Class V dental restorations, made in four different ways, one from each experimental group,
      using the same universal self-etching adhesive system, which is the tested material in this
      study. Non-carious cervical lesions will receive the applied adhesive system in 4 different
      protocols separated by groups. Group Self Etching (SET) (control): no conditioning, the
      adhesive system will be used in 50 teeth, according to the manufacturer's instructions, in
      the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity,
      will be air-dried during 5 seconds, and activated during 10 seconds with Light Emission Diode
      (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be applied during
      30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity
      will be air-dried, and then, the adhesive will be applied according to the manufacturer's
      instructions, as described in group SET; Group ERDry (Etch& Rinse Dry): 37% phosphoric acid
      will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50
      teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin
      dry, and then, the adhesive will be applied according to the manufacturer's instructions, as
      described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid will be applied
      during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50 teeth. This
      acid will be removed using water, the cavity will be air-dried, keeping dentin wet, and then,
      the adhesive will be applied according to the manufacturer's instructions, as described in
      group SET. After applying the adhesive, the restorations will be made with composite resin,
      and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using
      scores. To determine in which group each tooth will be enrolled, the authors will randomize
      the teeth.
This is a Treatment clinical trial, randomized, controlled, parallel, double-blinded, with
      four groups, that aims to evaluate the best application strategy when using a new Universal
      Adhesive system, Futurabond Universal (VOCO GmbH, Germany). Volunteers will be selected and
      recruited,following inclusion criteria and pre-established exclusion. All volunteers will be
      informed and sign a term of clarification and consent. All 50 enrolled patients will receive
      Class V dental restorations, made in four different ways, one from each experimental group,
      using the same universal self-etching adhesive system, which is the tested material in this
      study. All patients must have at only 20 teeth in function, must have at only 2 non carious
      cervical lesions (NCCL), in different teeth, that need restoration. Those lesions must be non
      carious, must be more than 1 mm deep, should have exposed dentin, and must have at only 50%
      of margins in enamel. Teeth should not present periodontal mobility. Firstly, the patient
      will be anesthetized locally with 3% Mepivacaine solution, followed by prophylaxis with
      pumice powder and water. All cavities will be washed and dried after these procedures for
      optimal selection of color, using a color scale. Then, the rubber dam isolation of the teeth
      to be restored will be held. Non-carious cervical lesions will receive the applied adhesive
      system in 4 different protocols separated by groups. Group Self Etching (SET) (control): no
      conditioning, the adhesive system will be used in 50 teeth, according to the manufacturer's
      instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds
      in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with Light
      Emission Diode (LED) light; Group SEE (Selective enamel etching): 37% phosphoric acid will be
      applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water,
      the cavity will be air-dried, and then, the adhesive will be applied according to the
      manufacturer's instructions, as described in group SET; Group ERDry (Etch& Rinse Dry): 37%
      phosphoric acid will be applied during 30 seconds, only in enamel and during 15 seconds only
      in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried,
      keeping dentin dry, and then, the adhesive will be applied according to the manufacturer's
      instructions, as described in group SET; Group ERWet (Etch& Rinse Wet): 37% phosphoric acid
      will be applied during 30 seconds, only in enamel and during 15 seconds only in dentin, in 50
      teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin
      wet, and then, the adhesive will be applied according to the manufacturer's instructions, as
      described in group SET. After applying the adhesive, the restorations will be made with
      composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain
      assessment, shape, staining or recurrent caries, using scores. To determine in which group
      each tooth will be enrolled, the authors will randomize the teeth.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Restoration Loss
time frame: Four years
description: It will be evaluated the increase in the number of losses of dental restorations in the period of four years, verified by periodic visual clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of remaining restorations in the different groups.
measure: Marginal Pigmentation
time frame: Four years
description: It will be evaluated the increase in the number of dental restorations with marginal pigmentation in the period of four years, verified by periodic clinical visual examination (6/6 months) based on the statement of difference of at least 25% in the amount of stained restorations in the different groups.
measure: Post-Operative Hypersensitivity
time frame: Four years
description: It will be evaluated the increase in the number of dental restorations with dentin hypersensitivity in the period of four years, verified by periodic clinical examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with dentin hypersensitivity in the different groups.
measure: Secondary Caries
time frame: Four years
description: It will be evaluated the increase in the number of dental restorations with secondary caries in the period of four years, verified by periodic radiographic examination (6/6 months) based on the statement of difference of at least 25% in the amount of restorations with secondary caries in the different groups.
arm group label: SET (Self-Etching)
arm group type: Active Comparator
description: 50 teeth will receive restorations using Self-Etching Application Strategy
arm group label: SEE (Selective Enamel Etching)
arm group type: Experimental
description: 50 teeth will receive restorations using Enamel Etching Application Strategy
arm group label: ERDry (Etch&Rinse Dry)
arm group type: Experimental
description: 50 teeth will receive restorations using Etch&Rinse Dry Application Strategy, leaving dentin dry (but not overdry)
arm group label: ERWet (Etch&Rinse Wet)
arm group type: Experimental
description: 50 teeth will receive restorations using Etch&Rinse Wet Application Strategy, leaving dentin wet
intervention type: Other
intervention name: Self-Etching Application Strategy
description: In Group SET, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions, in the self-etching mode. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
arm group label: SET (Self-Etching)
intervention type: Other
intervention name: Enamel Etching Application Strategy
description: In Group SEE, 37% phosphoric acid will be applied during 30 seconds, only in enamel in 50 teeth. This acid will be removed using water, the cavity will be air-dried, and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
arm group label: SEE (Selective Enamel Etching)
intervention type: Other
intervention name: Etch&Rinse Dry Application Strategy
description: In Group ERDry, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin dry (but not overdry) and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
arm group label: ERDry (Etch&Rinse Dry)
intervention type: Other
intervention name: Etch&Rinse Wet Application Strategy
description: In Group ERWet, 37% phosphoric acid will be applied during 30 seconds, only in enamel, and 15 seconds, only in dentin, in 50 teeth. This acid will be removed using water, the cavity will be air-dried, keeping dentin wet and then, the adhesive system Futurabond Universal will be used in 50 teeth, according to the manufacturer's instructions. The adhesive system will be brushed during 20 seconds in the cavity, will be air-dried during 5 seconds, and activated during 10 seconds with LED light; After applying the adhesive, the restorations will be made with composite Admira Fusion (VOCO GmbH, Germany), and evaluated every 6 months for pain assessment, shape, staining or recurrent caries, using scores.
arm group label: ERWet (Etch&Rinse Wet)
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: MARCOS O BARCELEIRO, DDS, PhD
role: Study Director
affiliation: Universidade Federal Fluminense
last name: ALESSANDRO D LOGUERCIO, DDS, PhD
role: Principal Investigator
affiliation: Universidade Estadual de Ponta Grossa
facility: 
facility: 
country: Brazil
citation: Pashley DH, Tay FR. Aggressiveness of contemporary self-etching adhesives. Part II: etching effects on unground enamel. Dent Mater. 2001 Sep;17(5):430-44. doi: 10.1016/s0109-5641(00)00104-4.
PMID: 11445211
citation: Perdigao J, Kose C, Mena-Serrano AP, De Paula EA, Tay LY, Reis A, Loguercio AD. A new universal simplified adhesive: 18-month clinical evaluation. Oper Dent. 2014 Mar-Apr;39(2):113-27. doi: 10.2341/13-045-C. Epub 2013 Jun 26.
PMID: 23802645
citation: Erhardt MC, Cavalcante LM, Pimenta LA. Influence of phosphoric acid pretreatment on self-etching bond strengths. J Esthet Restor Dent. 2004;16(1):33-40; discussion 41. doi: 10.1111/j.1708-8240.2004.tb00448.x.
PMID: 15259541
citation: Erickson RL, Barkmeier WW, Latta MA. The role of etching in bonding to enamel: a comparison of self-etching and etch-and-rinse adhesive systems. Dent Mater. 2009 Nov;25(11):1459-67. doi: 10.1016/j.dental.2009.07.002. Epub 2009 Aug 7.
PMID: 19665220
citation: Torii Y, Itou K, Nishitani Y, Ishikawa K, Suzuki K. Effect of phosphoric acid etching prior to self-etching primer application on adhesion of resin composite to enamel and dentin. Am J Dent. 2002 Oct;15(5):305-8.
PMID: 12537339
citation: Van Landuyt KL, Peumans M, De Munck J, Lambrechts P, Van Meerbeek B. Extension of a one-step self-etch adhesive into a multi-step adhesive. Dent Mater. 2006 Jun;22(6):533-44. doi: 10.1016/j.dental.2005.05.010. Epub 2005 Nov 21.
PMID: 16300826
citation: da Costa TR, Ferri LD, Loguercio AD, Reis A. Eighteen-month randomized clinical trial on the performance of two etch-and-rinse adhesives in non-carious cervical lesions. Am J Dent. 2014 Dec;27(6):312-7.
PMID: 25707085
citation: Lopes LS, Calazans FS, Hidalgo R, Buitrago LL, Gutierrez F, Reis A, Loguercio AD, Barceleiro MO. Six-month Follow-up of Cervical Composite Restorations Placed With a New Universal Adhesive System: A Randomized Clinical Trial. Oper Dent. 2016 Sep-Oct;41(5):465-480. doi: 10.2341/15-309-C. Epub 2016 Jul 5.
PMID: 27379834
citation: Swift EJ Jr, Perdigao J, Heymann HO, Wilder AD Jr, Bayne SC, May KN Jr, Sturdevant JR, Roberson TM. Eighteen-month clinical evaluation of a filled and unfilled dentin adhesive. J Dent. 2001 Jan;29(1):1-6. doi: 10.1016/s0300-5712(00)00050-6.
PMID: 11137632
citation: Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G. Recommendations for conducting controlled clinical studies of dental restorative materials. Int Dent J. 2007 Oct;57(5):300-2. doi: 10.1111/j.1875-595x.2007.tb00136.x. No abstract available.
PMID: 17992913
citation: Hickel R, Peschke A, Tyas M, Mjor I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
PMID: 20628774
citation: Dalton Bittencourt D, Ezecelevski IG, Reis A, Van Dijken JW, Loguercio AD. An 18-months' evaluation of self-etch and etch & rinse adhesive in non-carious cervical lesions. Acta Odontol Scand. 2005 Jun;63(3):173-8. doi: 10.1080/00016350510019874.
PMID: 16191912
responsible party type: Sponsor
sharing ipd: No