<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/NCT02999880</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2016-10-237</org_study_id>
    <nct_id>NCT02999880</nct_id>
  </id_info>
  <brief_title>Layering Technique Selection for Ultimate Aesthetics in Anterior Composites</brief_title>
  <official_title>Clinical Performance of Direct Anterior Composite Restorations Using Innovative Esthetic Dual-Shade Versus Polychromatic Natural Layering Technique Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      the importance of this study is to evaluate the clinical performance of direct anterior resin&#xD;
      composite restoration constructed using innovative esthetic dual-shade technique and another&#xD;
      restoration constructed using polychromatic natural layering technique with various finishing&#xD;
      and polishing steps.&#xD;
&#xD;
      The benefit from carrying out this study is to help the practitioners to decide the most&#xD;
      suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with&#xD;
      superior clinical performance direct anterior resin composite restoration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -Study setting: Study is to be conducted in the Conservative Dentistry Department - Cairo&#xD;
      University.&#xD;
&#xD;
        -  Interventions:&#xD;
&#xD;
             1. Preoperative clinical assessment:&#xD;
&#xD;
                (O.S) will diagnose and select patients according to inclusion and exclusion&#xD;
                criteria. He will record all base line data with understanding of patients' chief&#xD;
                complains and aesthetic needs after treatment. Moreover, he will provide guidance&#xD;
                for patients to prepare for the study.&#xD;
&#xD;
                  1. (A.H) and (G.Z) will take standard preoperative digital photographs before&#xD;
                     intervention by modifying mobile camera with smile lite (made in Switzerland)&#xD;
                     and smile capture 2016 contain 10 adaptors to allow connection between smile&#xD;
                     lite and the smartphone then photos will be saved in a computer.&#xD;
&#xD;
                  2. (A.H) and (G.Z) will take color shade using both Vita shade guide and&#xD;
                     Vita-Easy shade compact.&#xD;
&#xD;
                  3. .(A.H) and (G.Z) will ask patient for his satisfaction will be taken by visual&#xD;
                     analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100&#xD;
                     score refer to totally satisfied.&#xD;
&#xD;
                  4. (G.Z) and (A.H) will carry out all these tests at baseline, immediately after,&#xD;
                     6 and 12 months in post-operative follow-up visits.&#xD;
&#xD;
             2. Pre-operative planning (O.S) will be responsible for randomization according to&#xD;
                patient selection for the sealed envelope containing which half will receive the&#xD;
                control and the other will receive the intervention (Split mouth technique).&#xD;
                Control group will be performed using polychromatic composite layering technique&#xD;
                .Intervention group will be performed using dual shade composite layering&#xD;
                technique.&#xD;
&#xD;
             3. Intraoperative procedure: (G.Z) will do the following procedures:&#xD;
&#xD;
        -  Silicone matrix will be fabricated either directly in the patient mouth using lingual&#xD;
           surface of the remaining tooth structure and the existing restorations as a guide ,or&#xD;
           fabricated on a study cast after optimizing the shape and function of the teeth with a&#xD;
           wax up.&#xD;
&#xD;
        -  Teeth preparation: after complete removal of caries a 1.5mm 75° functional- esthetic&#xD;
           enamel bevel will prepared using 8888 diamond bur ( Brasseler, Savannah, GA, USA) on the&#xD;
           facial surface, the lingual bevel will be 45° functional bevel, then a coarse disc&#xD;
           (sof-lex,3M ESPE) will be used to extend the facial bevel where needed interproximally&#xD;
           and toward the gingival third of the facial surface.&#xD;
&#xD;
        -  Cleaning the teeth surface with fluoride-free paste(Depurdent, Dr Wild AG) and water.&#xD;
&#xD;
        -  Teflon tape will placed on the adjacent teeth to prevent there being etched.&#xD;
&#xD;
      Application of each material is done according to the manufacture instructions:&#xD;
&#xD;
        -  Application of 32% phosphoric acid (Uni-Etch,Bisco,Schaumburg, IL,USA) to enamel and&#xD;
           dentine for 15 seconds.&#xD;
&#xD;
        -  The acid etchant will then rinsed for 30 seconds, excess water will be eliminated and&#xD;
           dental adhesive ( Adper Single Bond 2, 3M ESPE))will be applied.&#xD;
&#xD;
        -  The silicon matrix will be seated followed by application of the lingual layer of&#xD;
           composite( Filtek Supreme Ultra Universal Restorative[3M ESPE]) to form the lingual&#xD;
           shell and after light curing the first increment the silicone matrix and Teflon tape&#xD;
           will be removed.&#xD;
&#xD;
      Dual-shade layering (Intervention):&#xD;
&#xD;
      Only two composite resin material shades will be used (opaque dentine composite and enamel&#xD;
      shade composite).&#xD;
&#xD;
      Polychromatic layering (Control):&#xD;
&#xD;
      Using and mixing different composite shades, opalescents and intensives.&#xD;
&#xD;
        -  Finishing and polishing: will be performed using all grates of sof-lex discs (sof-lex,3M&#xD;
           ESPE) , fine and Extra fine diamond burs (Brasseler), finishing strips, medium and fine&#xD;
           rubber polishing points( Jiffy Polishers, Ultradent).&#xD;
&#xD;
           d) Postoperative procedure:&#xD;
&#xD;
        -  Patient satisfaction: using Visual analogue scale (0-100mm), 0 score refer to not&#xD;
           satisfied at all, while 100 score refer to totally satisfied.&#xD;
&#xD;
        -  Digital photographs using digital camera&#xD;
&#xD;
        -  Color shade using Vita Easy shade:&#xD;
&#xD;
        -  Clinical evaluation using FDI criteria:&#xD;
&#xD;
      (A.H) and (G.Z) will record all result outcomes on the following duration: immediately after,&#xD;
      6 and 12 months in post-operative follow-up visits.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date>July 2017</start_date>
  <completion_date type="Anticipated">September 2018</completion_date>
  <primary_completion_date type="Anticipated">July 2018</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient satisfaction</measure>
    <time_frame>Change in satisfaction from baseline, after6 months and 0ne year</time_frame>
    <description>Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Color shade</measure>
    <time_frame>change in shade from baseline, after six months and one year</time_frame>
    <description>Numerical</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Clinical performance including anatomic form, marginal discoloration,surface roughness, marginal adaptation and recurrent caries.</measure>
    <time_frame>change from baseline, after six months and one year</time_frame>
    <description>Numerical</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">2</enrollment>
  <condition>Poor Aesthetics of Existing Restoration</condition>
  <arm_group>
    <arm_group_label>Polychromatic layering (Control):</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Using and mixing different composite shades, opalescents and intensives.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dual-shade layering (Intervention):</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Only two composite resin material shades the opaque dentin composite and enamel shade composite.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Polychromatic layering</intervention_name>
    <description>Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).</description>
    <arm_group_label>Polychromatic layering (Control):</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Inclusion Criteria for participants:&#xD;
&#xD;
               1. Patients with good general health.&#xD;
&#xD;
               2. Patients who will agree to the consent and will commit to follow-up period.&#xD;
&#xD;
               3. Fully erupted anterior teeth with defects.&#xD;
&#xD;
               4. Active caries, fractures, or defective Restorations in 6 anterior teeth.&#xD;
&#xD;
               5. At least one spot lesion for contra-lateral anterior teeth on each side in the&#xD;
                  same jaw&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria for participants:&#xD;
&#xD;
               1. Patients with any systemic disease that may affect normal healing.&#xD;
&#xD;
               2. Patient with bad oral hygiene.&#xD;
&#xD;
               3. Tetracycline or florsis staining.&#xD;
&#xD;
               4. Patients who could/would not participate in all times of follow-up.&#xD;
&#xD;
               5. Untreated periodontal disease was not allowed.&#xD;
&#xD;
               6. Patients participating in more than 1 dental study.&#xD;
&#xD;
               7. Patient received fluoride varnish during orthodontic treatment.&#xD;
&#xD;
               8. Fully erupted anterior teeth with no defects.&#xD;
&#xD;
               9. Patients with tendency to do bleaching during the study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 8, 2016</study_first_submitted>
  <study_first_submitted_qc>December 18, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 21, 2016</study_first_posted>
  <last_update_submitted>December 18, 2016</last_update_submitted>
  <last_update_submitted_qc>December 18, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ghada Ahmed Elzayat</investigator_full_name>
    <investigator_title>principle investigator</investigator_title>
  </responsible_party>
  <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/NCT02999880
org study id: CEBD-CU-2016-10-237
nct id: NCT02999880
lead sponsor: 
has dmc: Yes
the importance of this study is to evaluate the clinical performance of direct anterior resin
      composite restoration constructed using innovative esthetic dual-shade technique and another
      restoration constructed using polychromatic natural layering technique with various finishing
      and polishing steps.

      The benefit from carrying out this study is to help the practitioners to decide the most
      suitable, easy, perfect technique to provide an optimally aesthetic, long lasting with
      superior clinical performance direct anterior resin composite restoration.
-Study setting: Study is to be conducted in the Conservative Dentistry Department - Cairo
      University.

        -  Interventions:

             1. Preoperative clinical assessment:

                (O.S) will diagnose and select patients according to inclusion and exclusion
                criteria. He will record all base line data with understanding of patients' chief
                complains and aesthetic needs after treatment. Moreover, he will provide guidance
                for patients to prepare for the study.

                  1. (A.H) and (G.Z) will take standard preoperative digital photographs before
                     intervention by modifying mobile camera with smile lite (made in Switzerland)
                     and smile capture 2016 contain 10 adaptors to allow connection between smile
                     lite and the smartphone then photos will be saved in a computer.

                  2. (A.H) and (G.Z) will take color shade using both Vita shade guide and
                     Vita-Easy shade compact.

                  3. .(A.H) and (G.Z) will ask patient for his satisfaction will be taken by visual
                     analogue scale (0-100mm), 0 score refer to not satisfied at all, while 100
                     score refer to totally satisfied.

                  4. (G.Z) and (A.H) will carry out all these tests at baseline, immediately after,
                     6 and 12 months in post-operative follow-up visits.

             2. Pre-operative planning (O.S) will be responsible for randomization according to
                patient selection for the sealed envelope containing which half will receive the
                control and the other will receive the intervention (Split mouth technique).
                Control group will be performed using polychromatic composite layering technique
                .Intervention group will be performed using dual shade composite layering
                technique.

             3. Intraoperative procedure: (G.Z) will do the following procedures:

        -  Silicone matrix will be fabricated either directly in the patient mouth using lingual
           surface of the remaining tooth structure and the existing restorations as a guide ,or
           fabricated on a study cast after optimizing the shape and function of the teeth with a
           wax up.

        -  Teeth preparation: after complete removal of caries a 1.5mm 75° functional- esthetic
           enamel bevel will prepared using 8888 diamond bur ( Brasseler, Savannah, GA, USA) on the
           facial surface, the lingual bevel will be 45° functional bevel, then a coarse disc
           (sof-lex,3M ESPE) will be used to extend the facial bevel where needed interproximally
           and toward the gingival third of the facial surface.

        -  Cleaning the teeth surface with fluoride-free paste(Depurdent, Dr Wild AG) and water.

        -  Teflon tape will placed on the adjacent teeth to prevent there being etched.

      Application of each material is done according to the manufacture instructions:

        -  Application of 32% phosphoric acid (Uni-Etch,Bisco,Schaumburg, IL,USA) to enamel and
           dentine for 15 seconds.

        -  The acid etchant will then rinsed for 30 seconds, excess water will be eliminated and
           dental adhesive ( Adper Single Bond 2, 3M ESPE))will be applied.

        -  The silicon matrix will be seated followed by application of the lingual layer of
           composite( Filtek Supreme Ultra Universal Restorative[3M ESPE]) to form the lingual
           shell and after light curing the first increment the silicone matrix and Teflon tape
           will be removed.

      Dual-shade layering (Intervention):

      Only two composite resin material shades will be used (opaque dentine composite and enamel
      shade composite).

      Polychromatic layering (Control):

      Using and mixing different composite shades, opalescents and intensives.

        -  Finishing and polishing: will be performed using all grates of sof-lex discs (sof-lex,3M
           ESPE) , fine and Extra fine diamond burs (Brasseler), finishing strips, medium and fine
           rubber polishing points( Jiffy Polishers, Ultradent).

           d) Postoperative procedure:

        -  Patient satisfaction: using Visual analogue scale (0-100mm), 0 score refer to not
           satisfied at all, while 100 score refer to totally satisfied.

        -  Digital photographs using digital camera

        -  Color shade using Vita Easy shade:

        -  Clinical evaluation using FDI criteria:

      (A.H) and (G.Z) will record all result outcomes on the following duration: immediately after,
      6 and 12 months in post-operative follow-up visits.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patient satisfaction
time frame: Change in satisfaction from baseline, after6 months and 0ne year
description: Scale 0-100 cm, 0 is unsatisfied at all, 100 satisfied totally.
measure: Color shade
time frame: change in shade from baseline, after six months and one year
description: Numerical
measure: Clinical performance including anatomic form, marginal discoloration,surface roughness, marginal adaptation and recurrent caries.
time frame: change from baseline, after six months and one year
description: Numerical
arm group label: Polychromatic layering (Control):
arm group type: Experimental
description: Using and mixing different composite shades, opalescents and intensives.
arm group label: Dual-shade layering (Intervention):
arm group type: No Intervention
description: Only two composite resin material shades the opaque dentin composite and enamel shade composite.
intervention type: Procedure
intervention name: Polychromatic layering
description: Only two composite resin material shades will be used (opaque dentine composite and enamel shade composite).
arm group label: Polychromatic layering (Control):
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Ghada Ahmed Elzayat
investigator title: principle investigator
sharing ipd: No