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/NCT06021028</url>
    </required_header>
    <id_info>
      <org_study_id>Cons2023</org_study_id>
      <nct_id>NCT06021028</nct_id>
    </id_info>
    <brief_title>Performance of GIOMER Based Resin Composite</brief_title>
    <official_title>Performance of GIOMER Based Resin Composite Restorations Versus Conventional Nanohybrid Resin Composite Restorations in Complex Proximal Carious Cavities in Posterior Teeth. (A 24-month 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>
      <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 the study is to clinically evaluate the performance of GIOMER based resin&#xD;
        composite restorations versus conventional nanohybrid resin composite restorations in complex&#xD;
        proximal carious cavities in posterior teeth over 2 years follow up. The null hypothesis will&#xD;
        be proposed that there will be no difference in the clinical performance of GIOMER based&#xD;
        resin composite restorations versus conventional nanohybrid resin composite restorations in&#xD;
        complex proximal carious cavities in posterior teeth over 2 years follow up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Scientific background:&#xD;
  &#xD;
        One of the advancements in resin composite technology to support its use as a bioactive&#xD;
        material, is the evolution of GIOMER based resin composite material which has an added&#xD;
        benefit of sustained fluoride and other ions release and rechargeability. A distinguishing&#xD;
        feature of the &quot;giomer&quot; class of restorative materials is the stable surface prereacted glass&#xD;
        core (sPRG) that is lined with an ionomer in a resin matrix. This configuration enables the&#xD;
        glass core to be protected from moisture, giving it long term aesthetics and the durability&#xD;
        of conventional resin composites with ion release and recharge1. When evaluating the clinical&#xD;
        performance of low shrinkage giomer based resin composite (Beautifil II LS; Shofu Inc.)&#xD;
        compared with a conventional nanohybrid resin composite in class I and class II cavities, It&#xD;
        was found that in both groups, according to FDI criteria, the restorations were mostly rated&#xD;
        with best scores (Score 1 or 2) regarding the biological, functional, and optical parameters&#xD;
        2. Also, after five years of clinical performance, both the nano-hybrid giomer restorative&#xD;
        materials flowable giomer (Beautifil Flow Plus F00; Shofu Inc.) and the conventional&#xD;
        nano-hybrid giomer restorative material (Beautifil II; Shofu Inc.) were comparably acceptable&#xD;
        and not significantly different for any of the parameters evaluated in occlusal cavities 3.&#xD;
        Meanwhile in a recent systematic review, it was concluded that GIOMER based resin composites&#xD;
        showed similar clinical performance concerning marginal adaptation and better surface&#xD;
        roughness when compared to Resin-modified glass ionomer cement 4.&#xD;
  &#xD;
        Statement of the problem:&#xD;
  &#xD;
        The survival rate for resin-based composite restorations declined to roughly 85-90% after ten&#xD;
        years. Bulk fractures and wear, which accounted for about 70% of replacements, were the main&#xD;
        causes of restorative replacement. About 20% of the resin-based restorations were replaced&#xD;
        because of caries at the margins of the restorations, and 10% were due to retention loss,&#xD;
        poor color matching, poor marginal integrity, endodontic therapy, or cusp fracture 5. These&#xD;
        failures are correlated mainly with patient risk profile i.e., caries risk , presence of&#xD;
        parafunctional habits and those with high number of restored surfaces (complex cavities) 6.&#xD;
  &#xD;
        Rationale:&#xD;
  &#xD;
        In a retrospective study7, the percentage of clinically satisfactory complex Class II resin&#xD;
        composite was 78% after five years. The main reasons for the failure presented were related&#xD;
        to the fracture of the restoration (Bravo-16%) and defective marginal adaptation&#xD;
        (Charlie-8.2%). Although many studies have evaluated the clinical performance of GIOMER based&#xD;
        resin composite 2-4, none of them evaluated its clinical performance in complex Class II&#xD;
        cavities, up till now, where the restorations are subjected to high stress conditions.&#xD;
  &#xD;
        External validity:&#xD;
  &#xD;
        Offering the patient, a bioactive giomer based restoration with an added benefit of sustained&#xD;
        remineralizing fluoride and other ions release also rechargeability while on the same time it&#xD;
        has the long term aesthetics and clinical longevity of conventional resin composite&#xD;
        restorations.&#xD;
  &#xD;
        Choice of the comparator:&#xD;
  &#xD;
        A conventional nanohybrid resin composite material will be used as the comparator as it gives&#xD;
        an accepted long term clinical performance according to a recent systematic review 7. Aim of&#xD;
        the study:&#xD;
  &#xD;
        The aim of the study is to clinically evaluate the performance of GIOMER based resin&#xD;
        composite restorations versus conventional nanohybrid resin composite restorations in complex&#xD;
        proximal carious cavities in posterior teeth over 2 years follow up.&#xD;
  &#xD;
        Methods:&#xD;
  &#xD;
        Study Settings:&#xD;
  &#xD;
        This clinical trial will be held in Conservative dentistry department clinic, Faculty of&#xD;
        Dentistry- Cairo University, Egypt.&#xD;
  &#xD;
        Sample size Calculation:&#xD;
  &#xD;
        The sample size was calculated based on a previous study by Torres et al in 2020, in which&#xD;
        percentage of clinically excellent large class 2 restorations regarding fracture and&#xD;
        retention was 87.5%. By implementing a two tailed Z test for difference between two&#xD;
        independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size&#xD;
        needed was 34 per group in order to detect a difference of 30%. Sample size was increased by&#xD;
        10% to compensate for possible dropouts to reach 38 teeth per group. Sample size was&#xD;
        performed using G*Power version 3.1.9.2 for windows.&#xD;
  &#xD;
        Methods: Assignment of interventions&#xD;
  &#xD;
        Allocation:&#xD;
  &#xD;
        Sequence generation:&#xD;
  &#xD;
        Simple randomization will be made by a contributor, who will not be further involved in any&#xD;
        of the phases of the clinical trial, to generate random numbers using Random Sequence&#xD;
        Generator, Randomness and Integrity Services Ltd (https://www.random.org/).&#xD;
  &#xD;
        Allocation concealment:&#xD;
  &#xD;
        The operator will choose between random numbers placed in an opaque sealed envelope.&#xD;
  &#xD;
        Blinding:&#xD;
  &#xD;
        The participants and both assessors will be blinded to the type of the material used and the&#xD;
        application technique.&#xD;
  &#xD;
        Interventions:&#xD;
  &#xD;
        After profound local anesthesia, conservative cavity preparations will be performed with&#xD;
        highspeed burs under constant cooling. The cavity outline and carious tissue will be removed&#xD;
        following the recent conservative cavity preparation and caries excavation guidelines. All&#xD;
        restored teeth will be isolated using a rubber dam. After applying the suitable matrix system&#xD;
        and wooden wedge.&#xD;
  &#xD;
        Intervention group:&#xD;
  &#xD;
        Selective enamel etching with 37% phosphoric acid for 30 second will be done then the bonding&#xD;
        agent (BeautiBond Universal, Shofu, Inc., Japan) will be applied following the manufacturer's&#xD;
        instructions. The restorative material (Beautifil II, Shofu, Inc., Japan ) will be inserted&#xD;
        into the cavity which is converted into a class I configuration using a centripetal build-up&#xD;
        sequence and light cured following the manufacturer's instructions, then finished and&#xD;
        polished after occlusion adjustment.&#xD;
  &#xD;
        Comparator group:&#xD;
  &#xD;
        The universal bonding agent ( Prime and Bond Active, Dentsply Sirona ) will be applied&#xD;
        following the manufacturer's instructions with previous selective enamel etching with 37%&#xD;
        phosphoric acid for 30 seconds. The restorative material (Neo Spectra, Dentsply Sirona) will&#xD;
        be inserted into the cavity as mentioned before and light cured following the manufacturer's&#xD;
        instructions, then finished and polished after occlusion adjustment.&#xD;
  &#xD;
        Data collection methods:&#xD;
  &#xD;
        *Baseline data collection: For every patient medical and dental history will be obtained. All&#xD;
        patients will be given oral hygiene instructions before operative treatment, and they will be&#xD;
        referred to the periodontology department for scaling and polishing prior restorative&#xD;
        procedures if needed.&#xD;
  &#xD;
        *Outcome data collection: FDI criteria for clinical evaluation of dental restoration will be&#xD;
        used by the two assessors. If they differ in the evaluation score, they will discuss together&#xD;
        till reaching a consensus.&#xD;
  &#xD;
        Patient retention:&#xD;
  &#xD;
        The patients' phone number will be recorded in their charts. Before the follow up visit, the&#xD;
        patient will receive a reminder phone call by If the patient did not answer, another&#xD;
        appointment will be scheduled within a week.&#xD;
  &#xD;
        Data management:&#xD;
  &#xD;
        All data of the trial will be stored on a computer and encrypted using a password. Data will&#xD;
        be backed up on cloud storage to prevent it from being lost.&#xD;
  &#xD;
        Statistical methods:&#xD;
  &#xD;
        Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social&#xD;
        Sciences), version 25 (SPSS Inc., Chicago, IL). Numerical data will be represented as mean&#xD;
        and standard deviation or median and range. Categorical data will be represented as numbers&#xD;
        and percentages. Data will be explored for normality using Kolmogrov-Smirnov test and&#xD;
        Shapiro-Wilk test. Comparisons between two groups for normally distributed numeric variables&#xD;
        will be done using the Student's t-test while for non normally distributed numeric variables&#xD;
        will be done by Mann-Whitney test. Comparisons between categorical variables will be&#xD;
        performed using the chi square test. An equivalence limit will be tested. A p-value less than&#xD;
        or equal to 0.05 will be considered statistically significant. All tests will be two tailed.&#xD;
  &#xD;
        Harms:&#xD;
  &#xD;
        The operator would inform the participants about any possible harm (post-operative&#xD;
        hypersensitivity or fracture of the restoration). If present, participants are instructed to&#xD;
        contact the operator immediately by a phone call.&#xD;
  &#xD;
        Research ethics approval Application forms for conducting clinical trials, checklist and&#xD;
        informed consent of the Research Ethics Committee (REC) Faculty of Dentistry, Cairo&#xD;
        University will be fulfilled, this is to prevent any unethical management or harms during the&#xD;
        study toward the participants. The operator will be responsible for obtaining the informed&#xD;
        consents from the participants during the enrollment day.&#xD;
  &#xD;
        Protocol amendments If a new protocol will be used a protocol amendment will be registered&#xD;
        with a copy of the new protocol and an explanation about the reasons for it. If there is a&#xD;
        change in this protocol that affects trial ethics or the scientific content of the trial, an&#xD;
        amendment with brief explanation will be also submitted.&#xD;
  &#xD;
        Confidentiality The personal data of the participants will not present on the protocol form&#xD;
        and it would be secured for 10 years after the trial to protect their privacy.&#xD;
  &#xD;
        Declaration of interests There is no conflict of interest. Funding is accepted from Shofu,&#xD;
        Inc., Japan and Ivoclar Vivadent, Schaan, Liechtenstein.&#xD;
  &#xD;
        Ancillary and post-trial care Patients will be followed up after the restorative work to&#xD;
        maintain the oral hygiene measures. When there is any evidence of restoration failure,&#xD;
        patients will be treated by immediate restoration replacement by different restorative option&#xD;
        to the tooth.&#xD;
  &#xD;
        Dissemination policy Full protocol will be published online in www.clinicaltrials.gov to keep&#xD;
        the integrity of the research methods and to avoid repetition. The results of this clinical&#xD;
        trial will be internationally published.&#xD;
  &#xD;
        Declaration of originality:&#xD;
  &#xD;
        This research has not been submitted to any other universities, institutions or even persons&#xD;
        for the award of any degree, diploma, or publication any time before.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">August 1, 2023</start_date>
    <completion_date type="Anticipated">October 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 2025</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>Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Investigator, Outcomes Assessor)</masking>
      <masking_description>Triple (Investigator, Outcomes Assessor)</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Fracture &amp; retention</measure>
      <time_frame>24 months</time_frame>
      <description>FDI criteria Functional properties</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Rest of FDI criteria</measure>
      <time_frame>24 months</time_frame>
      <description>FDI criteria Functional properties</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">76</enrollment>
    <condition>Dental Caries</condition>
    <arm_group>
      <arm_group_label>Beautifil II Resin composite</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Giomer restorative</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Neo Spectra resin composite</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Nano-hybrid resin composite</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>complex proximal carious cavities in posterior teeth.</intervention_name>
      <description>Selective enamel etching with 37% phosphoric acid for 30 second will be done then the bonding agent will be applied following the manufacturer's instructions.</description>
      <arm_group_label>Beautifil II Resin composite</arm_group_label>
      <arm_group_label>Neo Spectra resin composite</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Inclusion Criteria of participants:&#xD;
  &#xD;
            1. Patients with proximal carious cavities in molars.&#xD;
  &#xD;
            2. 18 - 50 years.&#xD;
  &#xD;
            3. Males or Females.&#xD;
  &#xD;
            4. Good oral hygiene.&#xD;
  &#xD;
            5. Co-operative patients approving to participate in the study.&#xD;
  &#xD;
          Inclusion Criteria of teeth:&#xD;
  &#xD;
            1. Pulp asymptomatic vital carious complex class II upper or lower posterior teeth.&#xD;
  &#xD;
            2. The presence of favorable occlusion and teeth are in normal contact with the adjacent&#xD;
               teeth.&#xD;
  &#xD;
               -&#xD;
  &#xD;
               Exclusion Criteria:&#xD;
  &#xD;
                 -  Exclusion criteria of participants:&#xD;
  &#xD;
               Poor oral hygiene. Severe medical complications. Pregnancy. Allergic history&#xD;
               concerning methacrylates Heavy smoking. Xerostomia. Lack of compliance. Evidence of&#xD;
               parafunctional habits Temporomandibular joint disorders.&#xD;
  &#xD;
               Exclusion criteria of the teeth:&#xD;
  &#xD;
               Teeth involving more than three surfaces and indicated for indirect restorations.&#xD;
  &#xD;
               Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis. Severe&#xD;
               periodontal problems.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rawda Hesham Abd ElAziz, Phd</last_name>
      <role>Principal Investigator</role>
      <affiliation>Cairo University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Rawda Hesham Abd ElAziz, Phd</last_name>
      <phone>00201001097200</phone>
      <email>Rawda.hesham@dentistry.cu.edu.eg</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Dina Ezzeldin Mohamed, Phd</last_name>
      <email>Dina.ezz@dentistry.cu.edu.eg</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Mohamed Mohamed sabry Mohamed</name>
        <address>
          <city>Cairo</city>
          <state>Nasr City</state>
          <zip>11311</zip>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Mohamed Mohamed Sabry Mohamed, Phd</last_name>
        <phone>01113564856</phone>
        <email>mohamed.sabry@dentistry.cu.edu.eg</email>
      </contact>
      <contact_backup>
        <last_name>Mohamed Mohamed Sabry Mohamed, Phd</last_name>
        <phone>01005475566</phone>
        <email>Dr.mohamedsabry90@yahoo.com</email>
      </contact_backup>
      <investigator>
        <last_name>Mohamed Mohamed Sabry Mohamed, master</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 26, 2023</study_first_submitted>
    <study_first_submitted_qc>August 26, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>August 26, 2023</last_update_submitted>
    <last_update_submitted_qc>August 26, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 1, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Cairo University</investigator_affiliation>
      <investigator_full_name>Rawda Hesham Abd ElAziz</investigator_full_name>
      <investigator_title>Lecturer, Conservative dentistry department, Faculty of Dentistry</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06021028
  org study id: Cons2023
  nct id: NCT06021028
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the study is to clinically evaluate the performance of GIOMER based resin
        composite restorations versus conventional nanohybrid resin composite restorations in complex
        proximal carious cavities in posterior teeth over 2 years follow up. The null hypothesis will
        be proposed that there will be no difference in the clinical performance of GIOMER based
        resin composite restorations versus conventional nanohybrid resin composite restorations in
        complex proximal carious cavities in posterior teeth over 2 years follow up.
  Scientific background:
  
        One of the advancements in resin composite technology to support its use as a bioactive
        material, is the evolution of GIOMER based resin composite material which has an added
        benefit of sustained fluoride and other ions release and rechargeability. A distinguishing
        feature of the "giomer" class of restorative materials is the stable surface prereacted glass
        core (sPRG) that is lined with an ionomer in a resin matrix. This configuration enables the
        glass core to be protected from moisture, giving it long term aesthetics and the durability
        of conventional resin composites with ion release and recharge1. When evaluating the clinical
        performance of low shrinkage giomer based resin composite (Beautifil II LS; Shofu Inc.)
        compared with a conventional nanohybrid resin composite in class I and class II cavities, It
        was found that in both groups, according to FDI criteria, the restorations were mostly rated
        with best scores (Score 1 or 2) regarding the biological, functional, and optical parameters
        2. Also, after five years of clinical performance, both the nano-hybrid giomer restorative
        materials flowable giomer (Beautifil Flow Plus F00; Shofu Inc.) and the conventional
        nano-hybrid giomer restorative material (Beautifil II; Shofu Inc.) were comparably acceptable
        and not significantly different for any of the parameters evaluated in occlusal cavities 3.
        Meanwhile in a recent systematic review, it was concluded that GIOMER based resin composites
        showed similar clinical performance concerning marginal adaptation and better surface
        roughness when compared to Resin-modified glass ionomer cement 4.
  
        Statement of the problem:
  
        The survival rate for resin-based composite restorations declined to roughly 85-90% after ten
        years. Bulk fractures and wear, which accounted for about 70% of replacements, were the main
        causes of restorative replacement. About 20% of the resin-based restorations were replaced
        because of caries at the margins of the restorations, and 10% were due to retention loss,
        poor color matching, poor marginal integrity, endodontic therapy, or cusp fracture 5. These
        failures are correlated mainly with patient risk profile i.e., caries risk , presence of
        parafunctional habits and those with high number of restored surfaces (complex cavities) 6.
  
        Rationale:
  
        In a retrospective study7, the percentage of clinically satisfactory complex Class II resin
        composite was 78% after five years. The main reasons for the failure presented were related
        to the fracture of the restoration (Bravo-16%) and defective marginal adaptation
        (Charlie-8.2%). Although many studies have evaluated the clinical performance of GIOMER based
        resin composite 2-4, none of them evaluated its clinical performance in complex Class II
        cavities, up till now, where the restorations are subjected to high stress conditions.
  
        External validity:
  
        Offering the patient, a bioactive giomer based restoration with an added benefit of sustained
        remineralizing fluoride and other ions release also rechargeability while on the same time it
        has the long term aesthetics and clinical longevity of conventional resin composite
        restorations.
  
        Choice of the comparator:
  
        A conventional nanohybrid resin composite material will be used as the comparator as it gives
        an accepted long term clinical performance according to a recent systematic review 7. Aim of
        the study:
  
        The aim of the study is to clinically evaluate the performance of GIOMER based resin
        composite restorations versus conventional nanohybrid resin composite restorations in complex
        proximal carious cavities in posterior teeth over 2 years follow up.
  
        Methods:
  
        Study Settings:
  
        This clinical trial will be held in Conservative dentistry department clinic, Faculty of
        Dentistry- Cairo University, Egypt.
  
        Sample size Calculation:
  
        The sample size was calculated based on a previous study by Torres et al in 2020, in which
        percentage of clinically excellent large class 2 restorations regarding fracture and
        retention was 87.5%. By implementing a two tailed Z test for difference between two
        independent proportions with an alpha level of 5% and a power of 80%. The minimum sample size
        needed was 34 per group in order to detect a difference of 30%. Sample size was increased by
        10% to compensate for possible dropouts to reach 38 teeth per group. Sample size was
        performed using G*Power version 3.1.9.2 for windows.
  
        Methods: Assignment of interventions
  
        Allocation:
  
        Sequence generation:
  
        Simple randomization will be made by a contributor, who will not be further involved in any
        of the phases of the clinical trial, to generate random numbers using Random Sequence
        Generator, Randomness and Integrity Services Ltd (https://www.random.org/).
  
        Allocation concealment:
  
        The operator will choose between random numbers placed in an opaque sealed envelope.
  
        Blinding:
  
        The participants and both assessors will be blinded to the type of the material used and the
        application technique.
  
        Interventions:
  
        After profound local anesthesia, conservative cavity preparations will be performed with
        highspeed burs under constant cooling. The cavity outline and carious tissue will be removed
        following the recent conservative cavity preparation and caries excavation guidelines. All
        restored teeth will be isolated using a rubber dam. After applying the suitable matrix system
        and wooden wedge.
  
        Intervention group:
  
        Selective enamel etching with 37% phosphoric acid for 30 second will be done then the bonding
        agent (BeautiBond Universal, Shofu, Inc., Japan) will be applied following the manufacturer's
        instructions. The restorative material (Beautifil II, Shofu, Inc., Japan ) will be inserted
        into the cavity which is converted into a class I configuration using a centripetal build-up
        sequence and light cured following the manufacturer's instructions, then finished and
        polished after occlusion adjustment.
  
        Comparator group:
  
        The universal bonding agent ( Prime and Bond Active, Dentsply Sirona ) will be applied
        following the manufacturer's instructions with previous selective enamel etching with 37%
        phosphoric acid for 30 seconds. The restorative material (Neo Spectra, Dentsply Sirona) will
        be inserted into the cavity as mentioned before and light cured following the manufacturer's
        instructions, then finished and polished after occlusion adjustment.
  
        Data collection methods:
  
        *Baseline data collection: For every patient medical and dental history will be obtained. All
        patients will be given oral hygiene instructions before operative treatment, and they will be
        referred to the periodontology department for scaling and polishing prior restorative
        procedures if needed.
  
        *Outcome data collection: FDI criteria for clinical evaluation of dental restoration will be
        used by the two assessors. If they differ in the evaluation score, they will discuss together
        till reaching a consensus.
  
        Patient retention:
  
        The patients' phone number will be recorded in their charts. Before the follow up visit, the
        patient will receive a reminder phone call by If the patient did not answer, another
        appointment will be scheduled within a week.
  
        Data management:
  
        All data of the trial will be stored on a computer and encrypted using a password. Data will
        be backed up on cloud storage to prevent it from being lost.
  
        Statistical methods:
  
        Data will be analyzed using IBM SPSS advanced statistics (Statistical Package for Social
        Sciences), version 25 (SPSS Inc., Chicago, IL). Numerical data will be represented as mean
        and standard deviation or median and range. Categorical data will be represented as numbers
        and percentages. Data will be explored for normality using Kolmogrov-Smirnov test and
        Shapiro-Wilk test. Comparisons between two groups for normally distributed numeric variables
        will be done using the Student's t-test while for non normally distributed numeric variables
        will be done by Mann-Whitney test. Comparisons between categorical variables will be
        performed using the chi square test. An equivalence limit will be tested. A p-value less than
        or equal to 0.05 will be considered statistically significant. All tests will be two tailed.
  
        Harms:
  
        The operator would inform the participants about any possible harm (post-operative
        hypersensitivity or fracture of the restoration). If present, participants are instructed to
        contact the operator immediately by a phone call.
  
        Research ethics approval Application forms for conducting clinical trials, checklist and
        informed consent of the Research Ethics Committee (REC) Faculty of Dentistry, Cairo
        University will be fulfilled, this is to prevent any unethical management or harms during the
        study toward the participants. The operator will be responsible for obtaining the informed
        consents from the participants during the enrollment day.
  
        Protocol amendments If a new protocol will be used a protocol amendment will be registered
        with a copy of the new protocol and an explanation about the reasons for it. If there is a
        change in this protocol that affects trial ethics or the scientific content of the trial, an
        amendment with brief explanation will be also submitted.
  
        Confidentiality The personal data of the participants will not present on the protocol form
        and it would be secured for 10 years after the trial to protect their privacy.
  
        Declaration of interests There is no conflict of interest. Funding is accepted from Shofu,
        Inc., Japan and Ivoclar Vivadent, Schaan, Liechtenstein.
  
        Ancillary and post-trial care Patients will be followed up after the restorative work to
        maintain the oral hygiene measures. When there is any evidence of restoration failure,
        patients will be treated by immediate restoration replacement by different restorative option
        to the tooth.
  
        Dissemination policy Full protocol will be published online in www.clinicaltrials.gov to keep
        the integrity of the research methods and to avoid repetition. The results of this clinical
        trial will be internationally published.
  
        Declaration of originality:
  
        This research has not been submitted to any other universities, institutions or even persons
        for the award of any degree, diploma, or publication any time before.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized Parallel Controlled Trial. Trial type: Two, Parallel arm design. Trial framework: Equivalence frame Allocation ratio: 1:1.
  primary purpose: Treatment
  masking: Double (Investigator, Outcomes Assessor)
  masking description: Triple (Investigator, Outcomes Assessor)
  measure: Fracture & retention
  time frame: 24 months
  description: FDI criteria Functional properties
  measure: Rest of FDI criteria
  time frame: 24 months
  description: FDI criteria Functional properties
  arm group label: Beautifil II Resin composite
  arm group type: Experimental
  description: Giomer restorative
  arm group label: Neo Spectra resin composite
  arm group type: Active Comparator
  description: Nano-hybrid resin composite
  intervention type: Procedure
  intervention name: complex proximal carious cavities in posterior teeth.
  description: Selective enamel etching with 37% phosphoric acid for 30 second will be done then the bonding agent will be applied following the manufacturer's instructions.
  arm group label: Beautifil II Resin composite
  arm group label: Neo Spectra resin composite
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rawda Hesham Abd ElAziz, Phd
  role: Principal Investigator
  affiliation: Cairo University
  last name: Rawda Hesham Abd ElAziz, Phd
  phone: 00201001097200
  email: Rawda.hesham@dentistry.cu.edu.eg
  last name: Dina Ezzeldin Mohamed, Phd
  email: Dina.ezz@dentistry.cu.edu.eg
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Cairo University
  investigator full name: Rawda Hesham Abd ElAziz
  investigator title: Lecturer, Conservative dentistry department, Faculty of Dentistry
  mesh term: Dental Caries