xml: <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/NCT05984472</url>
    </required_header>
    <id_info>
      <org_study_id>18-11.1T/15</org_study_id>
      <nct_id>NCT05984472</nct_id>
    </id_info>
    <brief_title>3-year Clinical Performance of Prefabricated and Composite Veneers</brief_title>
    <acronym>Edelweiss</acronym>
    <official_title>3-year Clinical Performance of Prefabricated and Clear Template-formed Resin Composite Veneers</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ege University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ege University</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 aim of this study was to evaluate the clinical performances of Edelweiss prefabricated&#xD;
        veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U-&#xD;
        veneer transparent templates used for anterior diastema closure and tooth reshaping over&#xD;
        3-year.&#xD;
  &#xD;
        The patient group consisted of individuals who applied for aesthetic complaints on their&#xD;
        anterior teeth. 21 volunteer individuals without systemic disease were included in the study.&#xD;
        Patients were randomly selected for each group. In Group 1; 38 teeth (10 patients) were&#xD;
        restored with Edelweiss prefabricated veneers (Edelweiss Dentistry) in combination with&#xD;
        Edelweiss nanohybrid resin composite (Edelweiss Dentistry) and Prime&amp;Bond Universal (Dentsply&#xD;
        Sirona) adhesive system. In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo&#xD;
        SphereTec (Dentsply Sirona) resin composite in combination with U- veneer (Ultradent)&#xD;
        transparent templates and Prime&amp;Bond Universal adhesive systems. Properties of the&#xD;
        restorations were evaluated at baseline, 6, 12, 24, and 36 months using Modified Ryge&#xD;
        Criteria (USPHS Criteria). Data were evaluated using Chi-Square and Fisher's Exact tests&#xD;
        (p=0.05).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this study was to evaluate the clinical performances of Edelweiss prefabricated&#xD;
        veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U-&#xD;
        veneer transparent templates used for anterior diastema closure and tooth reshaping over&#xD;
        3-year.&#xD;
  &#xD;
        The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey&#xD;
        (18-11.1T/15; 28.11.2018). 21 patients (1 male, 20 females, mean age: 35) with aesthetic&#xD;
        complaints on their anterior teeth were treated with 74 restorations. 21 volunteer&#xD;
        individuals without systemic disease were included in the study. Patients were randomly&#xD;
        selected for each group. In Group 1; 38 teeth (10 patients) were restored with Edelweiss&#xD;
        prefabricated veneers (Edelweiss Dentistry) in combination with Edelweiss nanohybrid resin&#xD;
        composite (Edelweiss Dentistry) and Prime&amp;Bond Universal (Dentsply Sirona) adhesive system.&#xD;
        In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo SphereTec (Dentsply Sirona)&#xD;
        resin composite in combination with U- veneer (Ultradent) transparent templates and&#xD;
        Prime&amp;Bond Universal adhesive systems.&#xD;
  &#xD;
        Periodontal treatments, fillings, and bleaching treatments were performed, if necessary,&#xD;
        before any veneer treatment. For the pre-treatment records; 3 photographs (smile, anterior&#xD;
        occlusion, and upper anterior teeth alone) were taken from each patient. The &quot;Button Try&quot;&#xD;
        technique was used for color selection in both groups. Edelweiss sizing guide was used for&#xD;
        size selection in Group 1. U-Veneer (Ultradent) transparent templates were tried on the&#xD;
        labial surfaces of teeth to select the correct size in Group 2. Then teeth were cleaned with&#xD;
        non-fluoride pumice (Cleanic; Kerr Dental, ABD) using a polishing brush. Isolation of the&#xD;
        teeth and retraction of the lips were achieved with a disposable mouth retractor (OptraGate,&#xD;
        Ivoclar Vivadent). Prefabricated veneers were prepared for the cementation process in Group&#xD;
        1. Then the labial surfaces were etched using 36% phosphoric acid for 30 s. The etched&#xD;
        surfaces were rinsed for 30 s and dried. Prime&amp;Bond Universal (Dentsply Sirona) adhesive&#xD;
        system was applied on the labial surfaces of the teeth in accordance with user instructions&#xD;
        in both groups. In Group 1; Edelweiss nano hybrid resin composite was placed on the inner&#xD;
        surfaces of the prefabricated veneers before being applied on appropriate teeth. Then the&#xD;
        restorations were light-cured for 40 s from each surface (D-Light Pro, GC). In Group 2;&#xD;
        Ceram-X Duo SphereTec (Dentsply Sirona) nanohybrid resin composite with dentin color was&#xD;
        placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that&#xD;
        layer, Ceram-X Duo SphereTec (Dentsply Sirona) enamel shades were placed on the inner surface&#xD;
        of the transparent template and pressed against the labial surface of the tooth. After the&#xD;
        removal of the excess materials, the resin composite veneer was light-cured for 20 s from&#xD;
        each surface. Then the transparent template was removed.&#xD;
  &#xD;
        In both groups; gingival borders were adapted with contouring and polishing discs (Super-Snap&#xD;
        Rainbow Technique Kit, SHOFU). Then proximal surfaces were polished using proximal sandpaper&#xD;
        strips. Occlusion was checked for premature contacts. Two calibrated observers who were&#xD;
        blinded to the objective of this study performed the evaluations. Color match, marginal&#xD;
        adaptation, marginal discoloration, anatomic form, retention, secondary caries, and gloss&#xD;
        retention were the properties evaluated for the restorations at baseline, 6, 12, 24, and 36&#xD;
        months using Modified Ryge Criteria (USPHS Criteria). Data were evaluated using the&#xD;
        Chi-Square and Fisher's Exact tests (p=0.05).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 15, 2019</start_date>
    <completion_date type="Actual">January 15, 2020</completion_date>
    <primary_completion_date type="Actual">December 30, 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>Individual Randomized Assignment</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Care Provider)</masking>
      <masking_description>Double (Participant, Evaluator)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Marginal discoloration of prefabricated and resin composite veneers</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal discoloration by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.&#xD;
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.&#xD;
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Marginal adaptation of prefabricated and resin composite veneers</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.&#xD;
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.&#xD;
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Retention rates of prefabricated and resin composite veneers</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding retention rates by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.&#xD;
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.&#xD;
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Anatomic form of prefabricated and resin composite veneers</measure>
      <time_frame>3 years</time_frame>
      <description>Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.&#xD;
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.&#xD;
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Color changes of prefabricated and resin composite veneers</measure>
      <time_frame>3 years</time_frame>
      <description>Health Service criteria regarding color changes by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.&#xD;
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.&#xD;
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">21</enrollment>
    <condition>Dental Diseases</condition>
    <condition>Tooth Discoloration</condition>
    <arm_group>
      <arm_group_label>Edelweiss Prefabricated Veneers</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Edelweiss veneers (device 1) were randomly applied to patients. The teeth were evaluated in terms of color and size matching in order to select the correct veneers. Edelweiss sizing guide was used for size selection. Prefabricated veneers were adapted to the teeth' surfaces. Then, the inner surfaces of the prefabricated veneers were roughened to obtain better mechanical retention. Then the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were rinsed and dried. An adhesive system was applied to the teeth. Prefabricated veneers' inner surfaces were cleaned with alcohol, and Veneer Bond dental adhesive was applied. Edelweiss nanohybrid resin composite was placed on the inner surfaces of the veneers and transferred to the teeth. These restorations were light-cured for 40 s Gingival borders were adapted with contouring and polishing discs (intervention 1).</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Ceram-X Duo SphereTec with U-Veneer</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Direct resin composite restorations were randomly applied to patients. Ceram-X Duo SphereTec resin composite (device 2) was used for color selection. Then U-Veneer transparent templates were tried to select their correct size. After the preparation, the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were then rinsed and dried. An adhesive system was applied to the teeth. Then Ceram-X Duo SphereTec nanohybrid resin composite with dentin shade was placed on labial surfaces of teeth and was light-cured. After that Ceram-X Duo SphereTec nanohybrid resin composite enamel shade was placed on the inner surface of the transparent template and was transferred to the tooth. After that, the resin composite veneer was light-cured for 20 s from each surface. The transparent template was removed. Gingival borders were adapted with contouring and polishing discs. Then proximal surfaces were polished using proximal sandpaper strips (intervention 2).</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Edelweiss prefabricated veneers</intervention_name>
      <description>Individual Randomized Clinical Trial</description>
      <arm_group_label>Edelweiss Prefabricated Veneers</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Ceram-X Duo SphereTec with U-Veneer</intervention_name>
      <description>Ceram-X Duo SphereTec with U-Veneer</description>
      <arm_group_label>Ceram-X Duo SphereTec with U-Veneer</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Being healthy without any chronic disease&#xD;
  &#xD;
            -  Having diastema, peg lateral or enamel defect in the anterior teeth&#xD;
  &#xD;
            -  Not having an occlusal anomaly such as bruxism or anterior crossbite&#xD;
  &#xD;
            -  Having a good oral hygiene&#xD;
  &#xD;
            -  Agreeing to come to the recall sessions regularly for 18 months&#xD;
  &#xD;
            -  Being over the age of 18&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Having uncontrolled parafunction such as bruxism or anterior deep bite&#xD;
  &#xD;
            -  Having insufficient oral hygiene&#xD;
  &#xD;
            -  Being pregnant&#xD;
  &#xD;
            -  Having a systemic disease&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>60 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Ege University School of Dentistry Department of Restorative</name>
        <address>
          <city>İzmir</city>
          <state>Bornova</state>
          <zip>35040</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 1, 2023</study_first_submitted>
    <study_first_submitted_qc>August 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 9, 2023</study_first_posted>
    <last_update_submitted>August 8, 2023</last_update_submitted>
    <last_update_submitted_qc>August 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 9, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ege University</investigator_affiliation>
      <investigator_full_name>Sebnem Turkun</investigator_full_name>
      <investigator_title>Prof. Dr.</investigator_title>
    </responsible_party>
    <keyword>veneers</keyword>
    <keyword>anterior restorations</keyword>
    <keyword>resin composite</keyword>
    <keyword>prefabricated veneers</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Stomatognathic Diseases</mesh_term>
      <mesh_term>Tooth Discoloration</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05984472
  org study id: 18-11.1T/15
  nct id: NCT05984472
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this study was to evaluate the clinical performances of Edelweiss prefabricated
        veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U-
        veneer transparent templates used for anterior diastema closure and tooth reshaping over
        3-year.
  
        The patient group consisted of individuals who applied for aesthetic complaints on their
        anterior teeth. 21 volunteer individuals without systemic disease were included in the study.
        Patients were randomly selected for each group. In Group 1; 38 teeth (10 patients) were
        restored with Edelweiss prefabricated veneers (Edelweiss Dentistry) in combination with
        Edelweiss nanohybrid resin composite (Edelweiss Dentistry) and Prime&Bond Universal (Dentsply
        Sirona) adhesive system. In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo
        SphereTec (Dentsply Sirona) resin composite in combination with U- veneer (Ultradent)
        transparent templates and Prime&Bond Universal adhesive systems. Properties of the
        restorations were evaluated at baseline, 6, 12, 24, and 36 months using Modified Ryge
        Criteria (USPHS Criteria). Data were evaluated using Chi-Square and Fisher's Exact tests
        (p=0.05).
  The aim of this study was to evaluate the clinical performances of Edelweiss prefabricated
        veneers and direct resin composite restorations (Ceram-X Duo SphereTec) performed with U-
        veneer transparent templates used for anterior diastema closure and tooth reshaping over
        3-year.
  
        The study protocol was approved by the Ethical Committee of Ege University, Izmir, Turkey
        (18-11.1T/15; 28.11.2018). 21 patients (1 male, 20 females, mean age: 35) with aesthetic
        complaints on their anterior teeth were treated with 74 restorations. 21 volunteer
        individuals without systemic disease were included in the study. Patients were randomly
        selected for each group. In Group 1; 38 teeth (10 patients) were restored with Edelweiss
        prefabricated veneers (Edelweiss Dentistry) in combination with Edelweiss nanohybrid resin
        composite (Edelweiss Dentistry) and Prime&Bond Universal (Dentsply Sirona) adhesive system.
        In Group 2; 36 teeth (11 patients) were restored with Ceram-X Duo SphereTec (Dentsply Sirona)
        resin composite in combination with U- veneer (Ultradent) transparent templates and
        Prime&Bond Universal adhesive systems.
  
        Periodontal treatments, fillings, and bleaching treatments were performed, if necessary,
        before any veneer treatment. For the pre-treatment records; 3 photographs (smile, anterior
        occlusion, and upper anterior teeth alone) were taken from each patient. The "Button Try"
        technique was used for color selection in both groups. Edelweiss sizing guide was used for
        size selection in Group 1. U-Veneer (Ultradent) transparent templates were tried on the
        labial surfaces of teeth to select the correct size in Group 2. Then teeth were cleaned with
        non-fluoride pumice (Cleanic; Kerr Dental, ABD) using a polishing brush. Isolation of the
        teeth and retraction of the lips were achieved with a disposable mouth retractor (OptraGate,
        Ivoclar Vivadent). Prefabricated veneers were prepared for the cementation process in Group
        1. Then the labial surfaces were etched using 36% phosphoric acid for 30 s. The etched
        surfaces were rinsed for 30 s and dried. Prime&Bond Universal (Dentsply Sirona) adhesive
        system was applied on the labial surfaces of the teeth in accordance with user instructions
        in both groups. In Group 1; Edelweiss nano hybrid resin composite was placed on the inner
        surfaces of the prefabricated veneers before being applied on appropriate teeth. Then the
        restorations were light-cured for 40 s from each surface (D-Light Pro, GC). In Group 2;
        Ceram-X Duo SphereTec (Dentsply Sirona) nanohybrid resin composite with dentin color was
        placed on the labial surfaces of the teeth and light-cured (D-Light Pro, GC). After that
        layer, Ceram-X Duo SphereTec (Dentsply Sirona) enamel shades were placed on the inner surface
        of the transparent template and pressed against the labial surface of the tooth. After the
        removal of the excess materials, the resin composite veneer was light-cured for 20 s from
        each surface. Then the transparent template was removed.
  
        In both groups; gingival borders were adapted with contouring and polishing discs (Super-Snap
        Rainbow Technique Kit, SHOFU). Then proximal surfaces were polished using proximal sandpaper
        strips. Occlusion was checked for premature contacts. Two calibrated observers who were
        blinded to the objective of this study performed the evaluations. Color match, marginal
        adaptation, marginal discoloration, anatomic form, retention, secondary caries, and gloss
        retention were the properties evaluated for the restorations at baseline, 6, 12, 24, and 36
        months using Modified Ryge Criteria (USPHS Criteria). Data were evaluated using the
        Chi-Square and Fisher's Exact tests (p=0.05).
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Individual Randomized Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  masking description: Double (Participant, Evaluator)
  measure: Marginal discoloration of prefabricated and resin composite veneers
  time frame: 3 years
  description: Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal discoloration by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
  measure: Marginal adaptation of prefabricated and resin composite veneers
  time frame: 3 years
  description: Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding marginal adaptation by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
  measure: Retention rates of prefabricated and resin composite veneers
  time frame: 3 years
  description: Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding retention rates by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
  measure: Anatomic form of prefabricated and resin composite veneers
  time frame: 3 years
  description: Evaluating differently veneer options on anterior teeth with United State Public Health Service criteria regarding anatomic form by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
  measure: Color changes of prefabricated and resin composite veneers
  time frame: 3 years
  description: Health Service criteria regarding color changes by 2 independent evaluators Marginal discolouration was evaluated by 2 independent clinicians. Visual inspection with a mirror at 18 inches was performed . A score means the higher score of clinical acceptability while C score means that the restoration has failed and needs to be replaced. Alpha: No discoloration anywhere along the margin between the restoration and the adjacent tooth.
  Bravo: Slight discoloration along the margin between the restoration and the adjacent tooth.
  Charlie: The discoloration penetrated along the margin of the restorative material in a pulpal direction.
  arm group label: Edelweiss Prefabricated Veneers
  arm group type: Active Comparator
  description: Edelweiss veneers (device 1) were randomly applied to patients. The teeth were evaluated in terms of color and size matching in order to select the correct veneers. Edelweiss sizing guide was used for size selection. Prefabricated veneers were adapted to the teeth' surfaces. Then, the inner surfaces of the prefabricated veneers were roughened to obtain better mechanical retention. Then the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were rinsed and dried. An adhesive system was applied to the teeth. Prefabricated veneers' inner surfaces were cleaned with alcohol, and Veneer Bond dental adhesive was applied. Edelweiss nanohybrid resin composite was placed on the inner surfaces of the veneers and transferred to the teeth. These restorations were light-cured for 40 s Gingival borders were adapted with contouring and polishing discs (intervention 1).
  arm group label: Ceram-X Duo SphereTec with U-Veneer
  arm group type: Active Comparator
  description: Direct resin composite restorations were randomly applied to patients. Ceram-X Duo SphereTec resin composite (device 2) was used for color selection. Then U-Veneer transparent templates were tried to select their correct size. After the preparation, the labial surfaces of the teeth were etched using 36% phosphoric acid. The etched surfaces were then rinsed and dried. An adhesive system was applied to the teeth. Then Ceram-X Duo SphereTec nanohybrid resin composite with dentin shade was placed on labial surfaces of teeth and was light-cured. After that Ceram-X Duo SphereTec nanohybrid resin composite enamel shade was placed on the inner surface of the transparent template and was transferred to the tooth. After that, the resin composite veneer was light-cured for 20 s from each surface. The transparent template was removed. Gingival borders were adapted with contouring and polishing discs. Then proximal surfaces were polished using proximal sandpaper strips (intervention 2).
  intervention type: Procedure
  intervention name: Edelweiss prefabricated veneers
  description: Individual Randomized Clinical Trial
  arm group label: Edelweiss Prefabricated Veneers
  intervention type: Procedure
  intervention name: Ceram-X Duo SphereTec with U-Veneer
  description: Ceram-X Duo SphereTec with U-Veneer
  arm group label: Ceram-X Duo SphereTec with U-Veneer
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 60 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ege University
  investigator full name: Sebnem Turkun
  investigator title: Prof. Dr.
  mesh term: Stomatognathic Diseases
  mesh term: Tooth Discoloration
  sharing ipd: No