<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/NCT04438642</url>
  </required_header>
  <id_info>
    <org_study_id>Gadallah</org_study_id>
    <nct_id>NCT04438642</nct_id>
  </id_info>
  <brief_title>Biological and Esthetic Evaluation of Ceramic Onlay With Different Preparation Designs</brief_title>
  <official_title>Biological and Esthetic Evaluation of Ceramic Onlay With Different Preparation Designs (A Randomized Controlled Clinical Trial)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ahmed Adel Mahmoud Gadallah</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>
      Aim of study: is to asses biological and esthetical success of ceramic onlay restorations&#xD;
      while preparing the teeth using shoulder finish line preparation versus butt joint with bevel&#xD;
      preparation.&#xD;
&#xD;
      Methods:&#xD;
&#xD;
      Patients with need to posterior onlay restoration (premolars and molars) will be allocated&#xD;
      into two groups either conventional (shoulder finish line) or conservative group (butt joint&#xD;
      with bevel), after tooth preparation impression, restoration fabrication, try in, cementation&#xD;
      and restoration will be evaluated two weeks post cementation then follow up will be held&#xD;
      every two months for 1 year.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      -  Research objective: The aim of this study is to asses biological and esthetical success&#xD;
           of ceramic onlay restorations while preparing the teeth using shoulder finish line&#xD;
           preparation versus butt joint with bevel preparation.&#xD;
&#xD;
        -  Research Procedure:&#xD;
&#xD;
             -  Visit 1: Preoperative records, face-to-face adherence reminder session, clinical,&#xD;
                radiographic examination, intraoral photographs and primary impression (alginate&#xD;
                impression*) for diagnostic cast construction.&#xD;
&#xD;
             -  Visit 2: Tooth preparation according to its group either shoulder, or butt joint&#xD;
                with bevel preparation, secondary impression using addition silicone rubber base&#xD;
                material two step two viscosities technique and temporary restoration.&#xD;
&#xD;
             -  Visit 3: evaluation of e-max press onlay ceramic restoration on the cast then&#xD;
                evaluation intra-oral on the prepared tooth and permanent cementation of the final&#xD;
                restoration using adhesive resin cement.&#xD;
&#xD;
             -  Visit 4: Every 2 months post operatively follow-up visit for one year.&#xD;
&#xD;
             -  PICOTS P: Population: Patients requiring posterior onlays. I: Intervention: butt&#xD;
                joint finish line with bevel preparation for ceramic onlay.&#xD;
&#xD;
      C: comparator: shoulder finish line preparation for ceramic onlay.&#xD;
&#xD;
      O: Outcome:&#xD;
&#xD;
      Primary: Postoperative sensitivity Secondary: Marginal discoloration Tertiary: Secondary&#xD;
      Caries T: Time: 1 year. S: Study design: Randomized controlled clinical trial.&#xD;
&#xD;
        -  Research question For patients requiring posterior onlays, does the use of conservative&#xD;
           preparation offer better biological response and esthetics when compared to conventional&#xD;
           onlay preparation?&#xD;
&#xD;
        -  Participant timeline:&#xD;
&#xD;
        -  The patient will be treated in visits designated as follows:&#xD;
&#xD;
             -  Visit 1: Preoperative records, face-to-face adherence reminder session, clinical,&#xD;
                radiographic examination, intraoral photographs and primary impression (alginate&#xD;
                impression) for diagnostic cast construction.&#xD;
&#xD;
             -  Visit 2: Tooth preparation according to its group either shoulder, or butt joint&#xD;
                with bevel preparation, secondary impression using addition silicone rubber base&#xD;
                material two step two viscosities technique and temporary restoration.&#xD;
&#xD;
             -  Visit 3: evaluation of e-max press onlay ceramic restoration on the cast then&#xD;
                evaluation intra-oral on the prepared tooth and permanent cementation of the final&#xD;
                restoration using adhesive resin cement.&#xD;
&#xD;
             -  Visit 4: Every 2 months post operatively follow-up visit for one year.&#xD;
&#xD;
        -  Allocation&#xD;
&#xD;
      Randomization:&#xD;
&#xD;
      - Simple randomization will be done using computerized random number generator&#xD;
&#xD;
      Allocation:&#xD;
&#xD;
        -  Sequence generation&#xD;
&#xD;
        -  A dental colleague will allocate the participant patients into two groups with 1:1&#xD;
           allocation ratio by using computerized Sequence generation&#xD;
&#xD;
        -  Blinding&#xD;
&#xD;
        -  Double blinding (trial participants and outcome assessor)&#xD;
&#xD;
        -  Two dental colleague assessors who are blinded about the aim of the study and&#xD;
           participant's allocation will be responsible for assessing the outcomes of this study.&#xD;
&#xD;
      Data collection methods:&#xD;
&#xD;
        -  Primary 1ry: Postoperative sensitivity will be assessed by asking patients according to&#xD;
           modified USPHS criteria and given a score (Alpha, Bravo)&#xD;
&#xD;
        -  Secondary 2ry outcome: Marginal discoloration will be assessed according to modified&#xD;
           USPHS criteria and given a score (Alpha, Bravo B1, Bravo B2, Charlie).&#xD;
&#xD;
        -  Tertiary 3ry outcome: Secondary Caries will be assessed by visual and given a score&#xD;
           (Alpha, Bravo).&#xD;
&#xD;
      Plans to promote participant retention &amp; complete follow-up:&#xD;
&#xD;
        -  The main investigator will record telephone numbers and address of the patients included&#xD;
           in the study. All patients will be given a phone call before the next appointment. Many&#xD;
           efforts will be done to promote participant retention such as, sending SMS greetings in&#xD;
           the feasts, any celebration and in his/ her birthday.&#xD;
&#xD;
        -  Data management&#xD;
&#xD;
        -  The main investigator will enter patient data electronically. Patient files are to be&#xD;
           stored in Numerical order in a secured place.&#xD;
&#xD;
        -  Statistical methods&#xD;
&#xD;
        -  Qualitative data will be presented as frequencies and percentages. Chi-square test or&#xD;
           Fisher's Exact test when applicable will be used for comparisons related to qualitative&#xD;
           variables. Friedman's test will be used to study the changes by time within each group.&#xD;
           Dunn's test will be used for pair-wise comparisons when Friedman's test is significant.&#xD;
&#xD;
        -  The significance level will be set at P ≤ 0.05. Statistical analysis will be performed&#xD;
           with IBM® SPSS® Statistics Version 20 for Windows (SPSS, Inc., an IBM Company).&#xD;
&#xD;
      D) Data monitoring&#xD;
&#xD;
        -  Monitoring&#xD;
&#xD;
        -  The main supervisor is responsible of data monitoring if harms arise, interim analysis&#xD;
           will be done.&#xD;
&#xD;
        -  Harms&#xD;
&#xD;
        -  The main investigator will record, document and treat any adverse effect like pain or&#xD;
           even failure.&#xD;
&#xD;
        -  Expected risk to the human subjects:&#xD;
&#xD;
             1. Possibility of restoration dislodgment (the patient should keep the restoration and&#xD;
                contact the researcher as soon as possible as the restoration will be assessed for&#xD;
                cementation or replacement).&#xD;
&#xD;
             2. Possibility of restoration fracture (the patient should keep the fractured part and&#xD;
                contact the researcher as soon as possible as a new restoration will be placed).&#xD;
&#xD;
             3. In case failure of the onlay restoration the tooth will be assessed for the new&#xD;
                required restorative modality.&#xD;
&#xD;
        -  Consent&#xD;
&#xD;
        -  Researcher will discuss the trial with all patients. Patients will then be able to have&#xD;
           an informed discussion with the researcher. Researcher will obtain written consent from&#xD;
           patients willing to participate in the trial.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">November 9, 2019</start_date>
  <completion_date type="Anticipated">February 2022</completion_date>
  <primary_completion_date type="Anticipated">January 2022</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    <masking_description>double blinded</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>postoperative sensitivity</measure>
    <time_frame>1 year follow up</time_frame>
    <description>pain immediately after restoration cementation</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Marginal Discoloration</measure>
    <time_frame>1 year follow up</time_frame>
    <description>Margins between tooth and restoration have discoloration. Measuring device: visual and probe (used according to USPHS instructions)&#xD;
Measuring unit: Alpha, Bravo B1, Bravo B2, Charlie (according to USPHS measuring units) as following:&#xD;
Alpha: no discoloration along the margin.&#xD;
Bravo B1: discoloration noted along the margin less than 50 percent of exposed margin.&#xD;
Bravo B2: discoloration noted along the margin greater than 50 percent of exposed margin.&#xD;
Charlie: discoloration penetrating along the margin.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>secondary carries</measure>
    <time_frame>1 year follow up</time_frame>
    <description>carries that is developed due to restoration Measuring device: visual and probe (used according to USPHS instructions)&#xD;
Measuring unit: Alpha and Bravo (according to USPHS measuring units) as following:&#xD;
Alpha: carries absent along the margin.&#xD;
Bravo: carries present along the margin.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">38</enrollment>
  <condition>Unsatisfactory Restoration of Tooth</condition>
  <condition>Carious Teeth</condition>
  <arm_group>
    <arm_group_label>conventional ceramic onlay with shoulder finishline</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>tooth that need ceramic onlay restoration, a conventional cavity will be prepared with shoulder finishline.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conservative ceramic onlay preparation buttjoint with bevel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>tooth that need ceramic onlay restoration, a conservative cavity will be prepared with butt joint with bevel finishline.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>shoulder finishline</intervention_name>
    <description>tooth will be prepared having shoulder finishline.</description>
    <arm_group_label>conventional ceramic onlay with shoulder finishline</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>butt joint with bevel</intervention_name>
    <description>tooth will be prepared having butt joint with bevel finishline.</description>
    <arm_group_label>conservative ceramic onlay preparation buttjoint with bevel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  1-From 18-70 years old, be able to read and sign the informed consent document.30 2-&#xD;
             Have no active periodontal or pulpal diseases, have teeth with good restorations.&#xD;
&#xD;
             3- Psychologically and physically able to withstand conventional dental procedures 4-&#xD;
             Patients with teeth problems indicated for posterior onlay (molars or premolars).&#xD;
&#xD;
               1. Decayed teeth&#xD;
&#xD;
               2. Teeth restored with large filling restorations 5- Able to return for follow-up&#xD;
                  examinations and evaluation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patient less than 18 or more than 70 years&#xD;
&#xD;
          2. Patient with active resistant periodontal diseases&#xD;
&#xD;
          3. Patients with poor oral hygiene, high caries risk and uncooperative patients&#xD;
&#xD;
          4. Pregnant women&#xD;
&#xD;
          5. Patients in the growth stage with partially erupted teeth&#xD;
&#xD;
          6. Psychiatric problems or unrealistic expectations&#xD;
&#xD;
          7. Lack of opposing dentition in the area of interest. 8- the presence of a removable or&#xD;
             fixed orthodontic appliance, signs of bruxism or clenching, the absence of more than&#xD;
             one unit in the posterior region.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Cairo university Faculty Of Dentistry Fixed Prosthodontics clinic</name>
      <address>
        <city>Giza</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2021</verification_date>
  <study_first_submitted>February 25, 2020</study_first_submitted>
  <study_first_submitted_qc>June 17, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>July 28, 2021</last_update_submitted>
  <last_update_submitted_qc>July 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Ahmed Adel Mahmoud Gadallah</investigator_full_name>
    <investigator_title>PhD researcher</investigator_title>
  </responsible_party>
  <keyword>ceramic onlay</keyword>
  <keyword>conventional preparation</keyword>
  <keyword>conservative preparation</keyword>
  <keyword>Butt joint with bevel</keyword>
  <keyword>shoulder finish line</keyword>
  <keyword>biologic response</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>the outcome results</ipd_description>
  </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/NCT04438642
org study id: Gadallah
nct id: NCT04438642
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Aim of study: is to asses biological and esthetical success of ceramic onlay restorations
      while preparing the teeth using shoulder finish line preparation versus butt joint with bevel
      preparation.

      Methods:

      Patients with need to posterior onlay restoration (premolars and molars) will be allocated
      into two groups either conventional (shoulder finish line) or conservative group (butt joint
      with bevel), after tooth preparation impression, restoration fabrication, try in, cementation
      and restoration will be evaluated two weeks post cementation then follow up will be held
      every two months for 1 year.
-  Research objective: The aim of this study is to asses biological and esthetical success
           of ceramic onlay restorations while preparing the teeth using shoulder finish line
           preparation versus butt joint with bevel preparation.

        -  Research Procedure:

             -  Visit 1: Preoperative records, face-to-face adherence reminder session, clinical,
                radiographic examination, intraoral photographs and primary impression (alginate
                impression*) for diagnostic cast construction.

             -  Visit 2: Tooth preparation according to its group either shoulder, or butt joint
                with bevel preparation, secondary impression using addition silicone rubber base
                material two step two viscosities technique and temporary restoration.

             -  Visit 3: evaluation of e-max press onlay ceramic restoration on the cast then
                evaluation intra-oral on the prepared tooth and permanent cementation of the final
                restoration using adhesive resin cement.

             -  Visit 4: Every 2 months post operatively follow-up visit for one year.

             -  PICOTS P: Population: Patients requiring posterior onlays. I: Intervention: butt
                joint finish line with bevel preparation for ceramic onlay.

      C: comparator: shoulder finish line preparation for ceramic onlay.

      O: Outcome:

      Primary: Postoperative sensitivity Secondary: Marginal discoloration Tertiary: Secondary
      Caries T: Time: 1 year. S: Study design: Randomized controlled clinical trial.

        -  Research question For patients requiring posterior onlays, does the use of conservative
           preparation offer better biological response and esthetics when compared to conventional
           onlay preparation?

        -  Participant timeline:

        -  The patient will be treated in visits designated as follows:

             -  Visit 1: Preoperative records, face-to-face adherence reminder session, clinical,
                radiographic examination, intraoral photographs and primary impression (alginate
                impression) for diagnostic cast construction.

             -  Visit 2: Tooth preparation according to its group either shoulder, or butt joint
                with bevel preparation, secondary impression using addition silicone rubber base
                material two step two viscosities technique and temporary restoration.

             -  Visit 3: evaluation of e-max press onlay ceramic restoration on the cast then
                evaluation intra-oral on the prepared tooth and permanent cementation of the final
                restoration using adhesive resin cement.

             -  Visit 4: Every 2 months post operatively follow-up visit for one year.

        -  Allocation

      Randomization:

      - Simple randomization will be done using computerized random number generator

      Allocation:

        -  Sequence generation

        -  A dental colleague will allocate the participant patients into two groups with 1:1
           allocation ratio by using computerized Sequence generation

        -  Blinding

        -  Double blinding (trial participants and outcome assessor)

        -  Two dental colleague assessors who are blinded about the aim of the study and
           participant's allocation will be responsible for assessing the outcomes of this study.

      Data collection methods:

        -  Primary 1ry: Postoperative sensitivity will be assessed by asking patients according to
           modified USPHS criteria and given a score (Alpha, Bravo)

        -  Secondary 2ry outcome: Marginal discoloration will be assessed according to modified
           USPHS criteria and given a score (Alpha, Bravo B1, Bravo B2, Charlie).

        -  Tertiary 3ry outcome: Secondary Caries will be assessed by visual and given a score
           (Alpha, Bravo).

      Plans to promote participant retention & complete follow-up:

        -  The main investigator will record telephone numbers and address of the patients included
           in the study. All patients will be given a phone call before the next appointment. Many
           efforts will be done to promote participant retention such as, sending SMS greetings in
           the feasts, any celebration and in his/ her birthday.

        -  Data management

        -  The main investigator will enter patient data electronically. Patient files are to be
           stored in Numerical order in a secured place.

        -  Statistical methods

        -  Qualitative data will be presented as frequencies and percentages. Chi-square test or
           Fisher's Exact test when applicable will be used for comparisons related to qualitative
           variables. Friedman's test will be used to study the changes by time within each group.
           Dunn's test will be used for pair-wise comparisons when Friedman's test is significant.

        -  The significance level will be set at P ≤ 0.05. Statistical analysis will be performed
           with IBM® SPSS® Statistics Version 20 for Windows (SPSS, Inc., an IBM Company).

      D) Data monitoring

        -  Monitoring

        -  The main supervisor is responsible of data monitoring if harms arise, interim analysis
           will be done.

        -  Harms

        -  The main investigator will record, document and treat any adverse effect like pain or
           even failure.

        -  Expected risk to the human subjects:

             1. Possibility of restoration dislodgment (the patient should keep the restoration and
                contact the researcher as soon as possible as the restoration will be assessed for
                cementation or replacement).

             2. Possibility of restoration fracture (the patient should keep the fractured part and
                contact the researcher as soon as possible as a new restoration will be placed).

             3. In case failure of the onlay restoration the tooth will be assessed for the new
                required restorative modality.

        -  Consent

        -  Researcher will discuss the trial with all patients. Patients will then be able to have
           an informed discussion with the researcher. Researcher will obtain written consent from
           patients willing to participate in the trial.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
masking description: double blinded
measure: postoperative sensitivity
time frame: 1 year follow up
description: pain immediately after restoration cementation
measure: Marginal Discoloration
time frame: 1 year follow up
description: Margins between tooth and restoration have discoloration. Measuring device: visual and probe (used according to USPHS instructions)
Measuring unit: Alpha, Bravo B1, Bravo B2, Charlie (according to USPHS measuring units) as following:
Alpha: no discoloration along the margin.
Bravo B1: discoloration noted along the margin less than 50 percent of exposed margin.
Bravo B2: discoloration noted along the margin greater than 50 percent of exposed margin.
Charlie: discoloration penetrating along the margin.
measure: secondary carries
time frame: 1 year follow up
description: carries that is developed due to restoration Measuring device: visual and probe (used according to USPHS instructions)
Measuring unit: Alpha and Bravo (according to USPHS measuring units) as following:
Alpha: carries absent along the margin.
Bravo: carries present along the margin.
arm group label: conventional ceramic onlay with shoulder finishline
arm group type: Other
description: tooth that need ceramic onlay restoration, a conventional cavity will be prepared with shoulder finishline.
arm group label: conservative ceramic onlay preparation buttjoint with bevel
arm group type: Experimental
description: tooth that need ceramic onlay restoration, a conservative cavity will be prepared with butt joint with bevel finishline.
intervention type: Procedure
intervention name: shoulder finishline
description: tooth will be prepared having shoulder finishline.
arm group label: conventional ceramic onlay with shoulder finishline
intervention type: Procedure
intervention name: butt joint with bevel
description: tooth will be prepared having butt joint with bevel finishline.
arm group label: conservative ceramic onlay preparation buttjoint with bevel
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Ahmed Adel Mahmoud Gadallah
investigator title: PhD researcher
mesh term: Dental Caries
sharing ipd: No
ipd description: the outcome results