<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/NCT03832829</url>
  </required_header>
  <id_info>
    <org_study_id>10840098-604.01.01-E.34133</org_study_id>
    <nct_id>NCT03832829</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Posterior Indirect Resin Composite Restorations With PBE</brief_title>
  <official_title>Evaluation of Clinical Performance and Periodontal Status of Posterior Indirect Resin Composite (Nexco) Restorations With Proximal Box Elevation Technique: A Prospective Controlled Clinical Trial up to 3 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Istanbul Medipol University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ivoclar Vivadent AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Istanbul Medipol University Hospital</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>
      Evaluation of posterior indirect resin composite restorations with proximal box elevation&#xD;
      technique.&#xD;
&#xD;
      Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with&#xD;
      coverage of one or more cusps represent a very common clinical situation. When restoring deep&#xD;
      cervical margins biological and technical operative problems may occur. In order to make&#xD;
      clinical procedures less fault-prone 'Proximal Box Elevation' (PBE) is an option that refers&#xD;
      to application of composite resin in the deepest parts of the proximal areas in order to&#xD;
      reposition the cervical margin supragingivally prior to cavity preparation for an indirect&#xD;
      restoration.&#xD;
&#xD;
      This project aims to evaluate the clinical performance and periodontal status of posterior&#xD;
      indirect composite restorations with PBE. According to study design at least 60 patients will&#xD;
      be recruited to project and 80 restorations will be evaluated. The project will be carried&#xD;
      out at the School of Dentistry, Istanbul Medipol University,Turkey.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The rehabilitation of decayed or fractured posterior teeth using an indirect technique was&#xD;
      introduced for large cavities with coverage of one or more cusps. Problems of biological&#xD;
      nature and technical operative may be encountered when restoring large cavities extending&#xD;
      below the cement-enamel junction(CEJ).&#xD;
&#xD;
      Biological problems refers to the possible violation of the 'biological width', a recommended&#xD;
      distance of 3 mm or more between the restorative margins and the alveolar crest. The&#xD;
      technical operative problems include difficulties in tooth preparation, impression making,&#xD;
      adhesive cementation of the restoration, finishing and polishing in subgingival areas. In&#xD;
      order to eliminate these difficulties Proximal Box Elevation' (PBE) was introduced that&#xD;
      proposes application of composite resin in the deepest parts of the proximal areas in order&#xD;
      to reposition the cervical margin supragingivally. Whether the PBE technique is the most&#xD;
      optimal treatment option for the restoration of cavities extending below CEJ and how the&#xD;
      proposed advantages and possible disadvantages could affect the clinical performance of the&#xD;
      indirect restorations are the topics extensively discussed among clinicians.&#xD;
&#xD;
      According to results of in vitro studies, PBE was found to be effective in indirect resin&#xD;
      composite bonding to deep proximal boxes in terms of marginal quality and adaptation (1).&#xD;
&#xD;
      In a retrospective clinical study, 79 indirect composite restorations were clinically&#xD;
      examined following modified United States Public Health Service criteria. Survival rate was&#xD;
      91.1% and success rate was 84.8% after 5 years (2). Similarly, in another clinical study&#xD;
      success rate of 71 indirect composite restorations was reported as 100% after 36 months (3).&#xD;
      Nevertheless, not much scientific evidence on the influence of PBE technique on the longevity&#xD;
      of the restorations and the periodontal health could be found in the currently available&#xD;
      literature. Randomized controlled clinical trials with classification of baseline clinical&#xD;
      situation and standardization of cavity preparations are necessary to evaluate the clinical&#xD;
      performance of this technique.&#xD;
&#xD;
      This study will be carried out as a prospective study, with assessment of the restorations&#xD;
      after three years. 80 indirect composite restorations in at least 60 patients will be&#xD;
      included. Potential patients attending to Istanbul Medipol University Dental Clinics in&#xD;
      Istanbul will be invited to the study. The patients meeting the inclusion criteria will be&#xD;
      recruited. After giving their consent to take part in the study, baseline clinical situation&#xD;
      will be classified based on technical operative and biological parameters (4).&#xD;
&#xD;
      The treatment procedure is:&#xD;
&#xD;
      Restorative process in all cases, will start with coronal relocation of the margins using&#xD;
      flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite&#xD;
      build-up. Defined principles of morphology driven preparation technique will be followed for&#xD;
      standardization of cavity preparations. Impression making, fabrication of indirect&#xD;
      restoration with SR Nexco and adhesive cementation will be completed according to&#xD;
      manufacturer's instructions.&#xD;
&#xD;
      The control procedure is:&#xD;
&#xD;
      The restorations will be evaluated according to marginal adaptation, cavo surface marginal&#xD;
      discoloration, approximal contact, fractures and caries associated with restorations. The&#xD;
      periodontal status will be assessed with defined periodontal parameters. The controls will be&#xD;
      conducted after two weeks, six months, 1year, 2 and 3 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">September 11, 2018</start_date>
  <completion_date type="Anticipated">September 2025</completion_date>
  <primary_completion_date type="Actual">September 14, 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>A prospective clinical trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>FDI (World Dental Federation) criteria for dental restorations assessment</measure>
    <time_frame>at 3 years</time_frame>
    <description>Two independent investigators are responsible for evaluations. The primary outcome will consist in the FDI (World Dental Federation) instruments for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually. The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque accumulation according to the Silness &amp; Löe (1964) Plaque Index:</measure>
    <time_frame>at 3 years</time_frame>
    <description>The secondary outcome of the study relies on evaluation of periodontal status. Peridontal parameters will be scored between 0 and 3.&#xD;
0= No plaque in the gingival area.&#xD;
A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.&#xD;
Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.&#xD;
Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival Inflammation according to the Silness &amp; Löe (1964) Gingival Index.</measure>
    <time_frame>at 3 years</time_frame>
    <description>0= Normal gingival.&#xD;
Mild inflammation-slight change in colour, slight oedema. No bleeding on probing.&#xD;
Moderate inflammation-redness, oedema and glazing. Bleeding on probing.&#xD;
Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">80</enrollment>
  <condition>Unsatisfactory or Defective Restoration of Tooth</condition>
  <arm_group>
    <arm_group_label>Indirect restorations with SR Nexco</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Large posterior defects with at least one or more cuspal coverage in molars will be restored using the materials listed (SR Nexco). Procedures will be done using local anesthesia. The procedure, starts with removal of caries or defective restorations and coronal relocation of the the margins using flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite build-up. Defined principles of morphology driven preparation technique will be followed Impression making, fabrication of indirect restoration with SR Nexco and adhesive cementation will be completed according to manufacturer's instructions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Indirect composite restoration</intervention_name>
    <description>Restoration of tooth with extensive substance loss</description>
    <arm_group_label>Indirect restorations with SR Nexco</arm_group_label>
    <other_name>Onlay and overlay restoration</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Vital or endodontically treated posterior teeth with extensive substance loss&#xD;
&#xD;
          2. Caries removal or restoration replacement (i.e. amalgam, composite, glass-ionomer)&#xD;
&#xD;
          3. Large posterior defects with at least one or more cuspal coverage in molars&#xD;
&#xD;
          4. Proximal defects extending below CEJ and at least one or more cavity margin/margins&#xD;
             located beneath the gingival tissues&#xD;
&#xD;
          5. Maximum 2 indirect restorations with SR Nexco material in each patient&#xD;
&#xD;
          6. No obvious untreated caries in the rest of the dentition, dental health problems&#xD;
             (regularly checked by a dentist)&#xD;
&#xD;
          7. Good or moderate oral hygiene (plaque score of less than 30% in anterior region before&#xD;
             treatment)&#xD;
&#xD;
          8. No untreated periodontal disease (only DPSI 1, 2)&#xD;
&#xD;
          9. Subjects had to be over 18 years of age, be classified according to the American&#xD;
             Society of Anesthesiologists (ASA) as ASA I or ASA II, present with moderate to good&#xD;
             oral hygiene, and be free of periodontal disease (probing depth and attachment levels&#xD;
             within normal limits, no furcation involvement, and no mobility)&#xD;
&#xD;
         10. Appropriate isolation after cavity preparations&#xD;
&#xD;
         11. Subjects had to agree to keep the scheduled recall appointments for data collection&#xD;
             and maintenance and plan to stay in the area for at least 3 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Considerable horizontal and/or vertical mobility of teeth: tooth mobility index score&#xD;
             2 or 3 2. Considerable periodontal disease without treatment (DPSI 3-, 3+ and 4)&#xD;
&#xD;
          2. Poor endodontic prognosis&#xD;
&#xD;
          3. Pulp exposure&#xD;
&#xD;
          4. Patients who still want to bleach their teeth or bleached teeth less than 3 weeks ago&#xD;
&#xD;
          5. Extremely hypersensitive tooth&#xD;
&#xD;
          6. Excluding the teeth, without opposing natural dentition (either intact or restored&#xD;
             with intracoronal or extracoronal fixed restorations), and with a minimum of 20 teeth&#xD;
&#xD;
          7. Substance loss due to developmental anomalies (hypoplasia, amelogenesis imperfecta&#xD;
             etc.)&#xD;
&#xD;
          8. Subjects who presented severe wear facets and/or reported parafunctional activities&#xD;
             such as clenching or nocturnal bruxism&#xD;
&#xD;
          9. Subjects who are pregnant or breast feeding during the duration of the study&#xD;
&#xD;
         10. Subjects who are known to be allergic to the ingredients of resin materials&#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>
  <overall_official>
    <last_name>Mutlu Özcan, DDS,PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Zurich University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Istanbul Medipol University, Dental School</name>
      <address>
        <city>Istanbul</city>
        <zip>34083</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <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. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.</citation>
    <PMID>20847997</PMID>
  </reference>
  <results_reference>
    <citation>Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.</citation>
    <PMID>29153552</PMID>
  </results_reference>
  <results_reference>
    <citation>D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.</citation>
    <PMID>23695612</PMID>
  </results_reference>
  <results_reference>
    <citation>Dukic W, Dukic OL, Milardovic S, Delija B. Clinical evaluation of indirect composite restorations at baseline and 36 months after placement. Oper Dent. 2010 Mar-Apr;35(2):156-64. doi: 10.2341/09-133-C.</citation>
    <PMID>20420058</PMID>
  </results_reference>
  <results_reference>
    <citation>Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.</citation>
    <PMID>20305873</PMID>
  </results_reference>
  <verification_date>June 2023</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 6, 2019</study_first_posted>
  <last_update_submitted>June 8, 2023</last_update_submitted>
  <last_update_submitted_qc>June 8, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">June 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Istanbul Medipol University Hospital</investigator_affiliation>
    <investigator_full_name>Funda Ozturk Bozkurt</investigator_full_name>
    <investigator_title>Prof.</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/NCT03832829
org study id: 10840098-604.01.01-E.34133
nct id: NCT03832829
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Evaluation of posterior indirect resin composite restorations with proximal box elevation
      technique.

      Restoration of large posterior defects extending below the cemento-enamel junction (CEJ) with
      coverage of one or more cusps represent a very common clinical situation. When restoring deep
      cervical margins biological and technical operative problems may occur. In order to make
      clinical procedures less fault-prone 'Proximal Box Elevation' (PBE) is an option that refers
      to application of composite resin in the deepest parts of the proximal areas in order to
      reposition the cervical margin supragingivally prior to cavity preparation for an indirect
      restoration.

      This project aims to evaluate the clinical performance and periodontal status of posterior
      indirect composite restorations with PBE. According to study design at least 60 patients will
      be recruited to project and 80 restorations will be evaluated. The project will be carried
      out at the School of Dentistry, Istanbul Medipol University,Turkey.
The rehabilitation of decayed or fractured posterior teeth using an indirect technique was
      introduced for large cavities with coverage of one or more cusps. Problems of biological
      nature and technical operative may be encountered when restoring large cavities extending
      below the cement-enamel junction(CEJ).

      Biological problems refers to the possible violation of the 'biological width', a recommended
      distance of 3 mm or more between the restorative margins and the alveolar crest. The
      technical operative problems include difficulties in tooth preparation, impression making,
      adhesive cementation of the restoration, finishing and polishing in subgingival areas. In
      order to eliminate these difficulties Proximal Box Elevation' (PBE) was introduced that
      proposes application of composite resin in the deepest parts of the proximal areas in order
      to reposition the cervical margin supragingivally. Whether the PBE technique is the most
      optimal treatment option for the restoration of cavities extending below CEJ and how the
      proposed advantages and possible disadvantages could affect the clinical performance of the
      indirect restorations are the topics extensively discussed among clinicians.

      According to results of in vitro studies, PBE was found to be effective in indirect resin
      composite bonding to deep proximal boxes in terms of marginal quality and adaptation (1).

      In a retrospective clinical study, 79 indirect composite restorations were clinically
      examined following modified United States Public Health Service criteria. Survival rate was
      91.1% and success rate was 84.8% after 5 years (2). Similarly, in another clinical study
      success rate of 71 indirect composite restorations was reported as 100% after 36 months (3).
      Nevertheless, not much scientific evidence on the influence of PBE technique on the longevity
      of the restorations and the periodontal health could be found in the currently available
      literature. Randomized controlled clinical trials with classification of baseline clinical
      situation and standardization of cavity preparations are necessary to evaluate the clinical
      performance of this technique.

      This study will be carried out as a prospective study, with assessment of the restorations
      after three years. 80 indirect composite restorations in at least 60 patients will be
      included. Potential patients attending to Istanbul Medipol University Dental Clinics in
      Istanbul will be invited to the study. The patients meeting the inclusion criteria will be
      recruited. After giving their consent to take part in the study, baseline clinical situation
      will be classified based on technical operative and biological parameters (4).

      The treatment procedure is:

      Restorative process in all cases, will start with coronal relocation of the margins using
      flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite
      build-up. Defined principles of morphology driven preparation technique will be followed for
      standardization of cavity preparations. Impression making, fabrication of indirect
      restoration with SR Nexco and adhesive cementation will be completed according to
      manufacturer's instructions.

      The control procedure is:

      The restorations will be evaluated according to marginal adaptation, cavo surface marginal
      discoloration, approximal contact, fractures and caries associated with restorations. The
      periodontal status will be assessed with defined periodontal parameters. The controls will be
      conducted after two weeks, six months, 1year, 2 and 3 years.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: A prospective clinical trial
primary purpose: Treatment
masking: None (Open Label)
measure: FDI (World Dental Federation) criteria for dental restorations assessment
time frame: at 3 years
description: Two independent investigators are responsible for evaluations. The primary outcome will consist in the FDI (World Dental Federation) instruments for dental restorations assessment, as it was published after consensus in 2007 and updated in 2010. This instrument is composed of three dimensions (biological, functional and esthetic), each consisting of several items that are assessed by clinical and radiographic examination according to Likert scales of 5 terms. Some items are evaluated quantitatively, others visually. The worst score of all items is retained as the overall score of the restoration, thus resulting in a single (ordinal) primary outcome.
measure: Plaque accumulation according to the Silness & Löe (1964) Plaque Index:
time frame: at 3 years
description: The secondary outcome of the study relies on evaluation of periodontal status. Peridontal parameters will be scored between 0 and 3.
0= No plaque in the gingival area.
A film of plaque adhering to the free gingival margin and adjacent area of the tooth. The plaque may only be recognized by running a probe across the tooth surface.
Moderate accumulation of soft deposits within the gingival pocket, on the gingival pocket, on the gingival margin and/or adjacent tooth surface, which can be seen by the naked eye.
Abundance of soft matter within the gingival pocket and/or on the gingival margin and adjacent tooth surface.
measure: Gingival Inflammation according to the Silness & Löe (1964) Gingival Index.
time frame: at 3 years
description: 0= Normal gingival.
Mild inflammation-slight change in colour, slight oedema. No bleeding on probing.
Moderate inflammation-redness, oedema and glazing. Bleeding on probing.
Severe inflammation-marked redness and oedema. Ulceration. Tendency to spontaneous bleeding.
arm group label: Indirect restorations with SR Nexco
arm group type: Experimental
description: Large posterior defects with at least one or more cuspal coverage in molars will be restored using the materials listed (SR Nexco). Procedures will be done using local anesthesia. The procedure, starts with removal of caries or defective restorations and coronal relocation of the the margins using flowable composite with maximum thickness 1 to 1.5 mm and followed by resin composite build-up. Defined principles of morphology driven preparation technique will be followed Impression making, fabrication of indirect restoration with SR Nexco and adhesive cementation will be completed according to manufacturer's instructions.
intervention type: Device
intervention name: Indirect composite restoration
description: Restoration of tooth with extensive substance loss
arm group label: Indirect restorations with SR Nexco
other name: Onlay and overlay restoration
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mutlu Özcan, DDS,PhD
role: Principal Investigator
affiliation: Zurich University
facility: 
country: Turkey
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. J Adhes Dent. 2010 Aug;12(4):259-72. doi: 10.3290/j.jad.a19262.
PMID: 20847997
citation: Juloski J, Koken S, Ferrari M. Cervical margin relocation in indirect adhesive restorations: A literature review. J Prosthodont Res. 2018 Jul;62(3):273-280. doi: 10.1016/j.jpor.2017.09.005. Epub 2017 Nov 15.
PMID: 29153552
citation: D'Arcangelo C, Zarow M, De Angelis F, Vadini M, Paolantonio M, Giannoni M, D'Amario M. Five-year retrospective clinical study of indirect composite restorations luted with a light-cured composite in posterior teeth. Clin Oral Investig. 2014;18(2):615-24. doi: 10.1007/s00784-013-1001-8. Epub 2013 May 22.
PMID: 23695612
citation: Dukic W, Dukic OL, Milardovic S, Delija B. Clinical evaluation of indirect composite restorations at baseline and 36 months after placement. Oper Dent. 2010 Mar-Apr;35(2):156-64. doi: 10.2341/09-133-C.
PMID: 20420058
citation: Veneziani M. Adhesive restorations in the posterior area with subgingival cervical margins: new classification and differentiated treatment approach. Eur J Esthet Dent. 2010 Spring;5(1):50-76.
PMID: 20305873
responsible party type: Principal Investigator
investigator affiliation: Istanbul Medipol University Hospital
investigator full name: Funda Ozturk Bozkurt
investigator title: Prof.
sharing ipd: No