<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/NCT03798184</url>
  </required_header>
  <id_info>
    <org_study_id>2/2018</org_study_id>
    <nct_id>NCT03798184</nct_id>
  </id_info>
  <brief_title>Clinical Performance of Prime&amp;Bond Active in Self-etch or Selective-etch Mode With or Without Bioglass</brief_title>
  <official_title>Randomized Blind Clinical Trial, Four-armed Parallel of Clinical Performance of Prime&amp;Bond Active in Self-etch or Selective-etch With or Without Bioglass</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Valencia</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Valencia</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Composite restoration of non-carious cervical lesions has always been a challenge for the&#xD;
      clinician, considering that the most frequent cause of failure is retention loss.&#xD;
&#xD;
      Adhesion of composite restoration may be obtained by following four different etching&#xD;
      techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and&#xD;
      self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols.&#xD;
      With the introduction of universal adhesives such as Prime&amp;Bond Active (Dentsply Sirona) it&#xD;
      is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching&#xD;
      technique with orthophosphoric acid.&#xD;
&#xD;
      On the other hand, there has been an increase in the awareness of the importance of remaining&#xD;
      dental tissue preservation, avoiding preparation of a cavity. This is why it is now&#xD;
      preferable to use bioactive glass in order to increase micromechanical retention on the&#xD;
      dental surface, instead of the classical approach of preparing the surface with burs.&#xD;
&#xD;
      To date, there are no studies evaluating the clinical performance of the universal adhesive&#xD;
      Prime&amp;Bond Active on direct resin composite restoration of non-carious cervical lesions&#xD;
      neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using&#xD;
      sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate&#xD;
      the retention rate of composite restorations using Prime&amp;Bond Active and a previous&#xD;
      sandblasted surface with bioglass in a three-year follow-up, as well as the presence of&#xD;
      marginal discoloration, marginal integrity and marginal caries.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The protocol to be followed in the study is as follows:&#xD;
&#xD;
        1. Obtention of a written informed consent of all participants.&#xD;
&#xD;
        2. Complete medical and dental clinical record.&#xD;
&#xD;
        3. Administration of anesthesia and absolute rubber dam isolation.&#xD;
&#xD;
        4. Cavity cleaning with a prophylactic brush and rubber cup with pumice.&#xD;
&#xD;
        5. Randomly assigning each non-carious cervical lesion to one of the four experimental&#xD;
           groups:&#xD;
&#xD;
           5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel&#xD;
           etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass.&#xD;
           5.4. Self-etch without surface roughening.&#xD;
&#xD;
        6. In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting&#xD;
           with bioactive glass will be used in enamel.&#xD;
&#xD;
        7. In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric&#xD;
           acid is applied for 15 seconds in enamel, followed by profuse washing with air/water&#xD;
           spray for ten seconds and dried using air for 10 seconds without desiccating dentin.&#xD;
&#xD;
           In groups 5.3 and 5.4 this step is omitted.&#xD;
&#xD;
        8. Application of universal adhesive Prime&amp;Bond Active on enamel and dentin for 20 seconds.&#xD;
           Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and&#xD;
           then light curing for 20 seconds.&#xD;
&#xD;
        9. Application of a &quot;bulk fill&quot; composite resin and light curing, following manufacturer's&#xD;
           instructions.&#xD;
&#xD;
       10. Finishing and polishing of the restoration.&#xD;
&#xD;
       11. Monitoring and follow up: visits will be performed at six months, one year, two years&#xD;
           and three years. In each evaluation, two independent clinicians who do not participate&#xD;
           in the clinical procedures will evaluate each direct composite restoration according to&#xD;
           USPHS criteria (Modified United States Public Health Service).&#xD;
&#xD;
      The primary objective is to evaluate the retention of the restoration. The secondary&#xD;
      objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Anticipated">November 2021</completion_date>
  <primary_completion_date type="Anticipated">November 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention rate</measure>
    <time_frame>Three years</time_frame>
    <description>Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal discoloration</measure>
    <time_frame>Three years</time_frame>
    <description>Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal integrity</measure>
    <time_frame>Three years</time_frame>
    <description>The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Marginal caries</measure>
    <time_frame>Three years</time_frame>
    <description>The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service)</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">228</enrollment>
  <condition>Self-etch</condition>
  <condition>Selective-etch</condition>
  <condition>Bioactive Glass</condition>
  <condition>Direct Resin Composite Restoration</condition>
  <condition>Non-carious Cervical Lesion</condition>
  <condition>Universal Adhesive</condition>
  <arm_group>
    <arm_group_label>Selective-etch with bioglass surface roughening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Selective-etch without bioglass surface roughening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-etch with bioglass surface roughening</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Self-etch without bioglass surface roughening</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-carious cervical lesion restoration</intervention_name>
    <description>Restoration of non-carious cervical lesions with Prime&amp;Bond Active in self-etch or selective-etch mode with or without bioglass</description>
    <arm_group_label>Selective-etch with bioglass surface roughening</arm_group_label>
    <arm_group_label>Selective-etch without bioglass surface roughening</arm_group_label>
    <arm_group_label>Self-etch with bioglass surface roughening</arm_group_label>
    <arm_group_label>Self-etch without bioglass surface roughening</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients ≥ 18 years without systemic disease.&#xD;
&#xD;
          2. Presence of a non-carious cervical lesion with a minimum of 1.5 mm in depth and extent&#xD;
             to dentin.&#xD;
&#xD;
          3. Non-carious cervical lesions in premolars and molars.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of rampant caries or advanced periodontal disease.&#xD;
&#xD;
          2. Consumption of &gt; 2 cigarette pack/ day.&#xD;
&#xD;
          3. Presence of severe xerostomia or bruxism.&#xD;
&#xD;
          4. Methacrylate allergy.&#xD;
&#xD;
          5. Pregnancy.&#xD;
&#xD;
        Teeth with pulpal and/or periapical pathology, and endodontically treated teeth are&#xD;
        excluded from the study.&#xD;
&#xD;
        Teeth with previous pulp capping or previous class V restorations will also be excluded.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Valencia</name>
      <address>
        <city>Valencia</city>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>November 18, 2018</study_first_submitted>
  <study_first_submitted_qc>January 6, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>January 6, 2019</last_update_submitted>
  <last_update_submitted_qc>January 6, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 9, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Valencia</investigator_affiliation>
    <investigator_full_name>Cristina Pasarín Linares</investigator_full_name>
    <investigator_title>Teaching Assistant</investigator_title>
  </responsible_party>
  <keyword>Prime&amp;Bond Active</keyword>
  <keyword>Bioactive glass</keyword>
  <keyword>non-carious cervical lesion</keyword>
  <keyword>direct resin composite</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Uterine Cervical Diseases</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/NCT03798184
org study id: 2/2018
nct id: NCT03798184
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Composite restoration of non-carious cervical lesions has always been a challenge for the
      clinician, considering that the most frequent cause of failure is retention loss.

      Adhesion of composite restoration may be obtained by following four different etching
      techniques: total-etch in three steps, total-etch in two steps, self-etch in two steps, and
      self-etch in one step. Nowadays the tendency is to simplify the adhesive classic protocols.
      With the introduction of universal adhesives such as Prime&Bond Active (Dentsply Sirona) it
      is possible to obtain a total-etch pattern (enamel and dentine) without the classic etching
      technique with orthophosphoric acid.

      On the other hand, there has been an increase in the awareness of the importance of remaining
      dental tissue preservation, avoiding preparation of a cavity. This is why it is now
      preferable to use bioactive glass in order to increase micromechanical retention on the
      dental surface, instead of the classical approach of preparing the surface with burs.

      To date, there are no studies evaluating the clinical performance of the universal adhesive
      Prime&Bond Active on direct resin composite restoration of non-carious cervical lesions
      neither in a selective-etch mode (enamel etching) or a self-etch mode (no etching) or using
      sandblasting with bioactive glass. Therefore, the main objective of the study is to evaluate
      the retention rate of composite restorations using Prime&Bond Active and a previous
      sandblasted surface with bioglass in a three-year follow-up, as well as the presence of
      marginal discoloration, marginal integrity and marginal caries.
The protocol to be followed in the study is as follows:

        1. Obtention of a written informed consent of all participants.

        2. Complete medical and dental clinical record.

        3. Administration of anesthesia and absolute rubber dam isolation.

        4. Cavity cleaning with a prophylactic brush and rubber cup with pumice.

        5. Randomly assigning each non-carious cervical lesion to one of the four experimental
           groups:

           5.1. Selective enamel etching and surface roughening with bioglass 5.2. Selective enamel
           etching without surface roughening. 5.3. Self-etch and surface roughening with bioglass.
           5.4. Self-etch without surface roughening.

        6. In experimental groups which need surface roughening (group 5.1 and 5.3), sandblasting
           with bioactive glass will be used in enamel.

        7. In experimental groups with selective enamel etch (5.1 and 5.2), 37 % orthophosphoric
           acid is applied for 15 seconds in enamel, followed by profuse washing with air/water
           spray for ten seconds and dried using air for 10 seconds without desiccating dentin.

           In groups 5.3 and 5.4 this step is omitted.

        8. Application of universal adhesive Prime&Bond Active on enamel and dentin for 20 seconds.
           Subsequently, evaporation of the solvent is realized by applying air for 5 seconds and
           then light curing for 20 seconds.

        9. Application of a "bulk fill" composite resin and light curing, following manufacturer's
           instructions.

       10. Finishing and polishing of the restoration.

       11. Monitoring and follow up: visits will be performed at six months, one year, two years
           and three years. In each evaluation, two independent clinicians who do not participate
           in the clinical procedures will evaluate each direct composite restoration according to
           USPHS criteria (Modified United States Public Health Service).

      The primary objective is to evaluate the retention of the restoration. The secondary
      objectives are to evaluate marginal discoloration, marginal integrity and marginal caries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Retention rate
time frame: Three years
description: Presence of resin composite restorations of non-carious cervical lesions at the three-year follow-up examination.
measure: Marginal discoloration
time frame: Three years
description: Presence of marginal staining between the restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
measure: Marginal integrity
time frame: Three years
description: The quality of the interface between restoration and tooth will be evaluated following USPHS criteria (Modified United States Public Health Service)
measure: Marginal caries
time frame: Three years
description: The presence of clinical diagnosis of caries will be evaluated following USPHS criteria (Modified United States Public Health Service)
arm group label: Selective-etch with bioglass surface roughening
arm group type: Experimental
arm group label: Selective-etch without bioglass surface roughening
arm group type: Active Comparator
arm group label: Self-etch with bioglass surface roughening
arm group type: Experimental
arm group label: Self-etch without bioglass surface roughening
arm group type: Active Comparator
intervention type: Procedure
intervention name: Non-carious cervical lesion restoration
description: Restoration of non-carious cervical lesions with Prime&Bond Active in self-etch or selective-etch mode with or without bioglass
arm group label: Selective-etch with bioglass surface roughening
arm group label: Selective-etch without bioglass surface roughening
arm group label: Self-etch with bioglass surface roughening
arm group label: Self-etch without bioglass surface roughening
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: No
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Valencia
investigator full name: Cristina Pasarín Linares
investigator title: Teaching Assistant
mesh term: Uterine Cervical Diseases