<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/NCT04430205</url>
  </required_header>
  <id_info>
    <org_study_id>2370CELazio1</org_study_id>
    <nct_id>NCT04430205</nct_id>
  </id_info>
  <brief_title>Repair of Vertically Fractured Root</brief_title>
  <official_title>Repair of Vertically Fractured Root: An Observational Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Aim and background: The aim of this retrospective observational study is to evaluate the&#xD;
      survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF),&#xD;
      after tooth restoration either with fracture-fragment adhesive bonding or with amalgam&#xD;
      restoration.&#xD;
&#xD;
      Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48&#xD;
      females, mean age 50.5 years), presenting complete or partial root fracture, were treated&#xD;
      with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and&#xD;
      2019. Demographic and clinical variables were evaluated as predictors of extraction.&#xD;
      Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically&#xD;
      evaluated at the one year follow-up. All cases were treated by the same operator, using a&#xD;
      surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study&#xD;
      was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5&#xD;
      years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root&#xD;
      fracture, were included in this observational retrospective study. All the teeth were treated&#xD;
      according to one of two clinical protocols (adhesive or amalgam, see below). Besides a&#xD;
      general medical history and subjective and objective symptoms, the presence of the crack was&#xD;
      determined by the usage of a Leica 650 stereomicroscope with the help of methylene blue or&#xD;
      eosin-type dyes. The following parameters were gathered from the clinical charts to evaluate&#xD;
      possible risk factors for extraction: age, gender, tooth number and type of root fracture&#xD;
      (complete or partial). A vitality test was performed with an electrical test, and periodontal&#xD;
      probing was performed on six sites per tooth to detect probing defects, using a manual probe.&#xD;
      Periapical radiolucency at the moment of the diagnosis, survival in months and type of&#xD;
      coronal restoration at the diagnosis (no restoration, single crown, composite, amalgam) were&#xD;
      all explored. Presence of calcification in the canal, endo-treatment before the diagnosis of&#xD;
      fracture (no treatment, good endodontic treatment, surgical treatment, retreatment), canal&#xD;
      obstacles (i.e., broken files) and previous endo-canal retention (no retention, screw post,&#xD;
      fibre post, cast post, composite, amalgam) were all determined. Survival was also considered&#xD;
      at one, three, five and more than five years, and a qualitative evaluation of the tooth was&#xD;
      given (success, functional success: the tooth was asymptomatic; failure: the tooth would be&#xD;
      extracted; extracted: the tooth was extracted before the control visit), modifying the&#xD;
      European Society of Endodontology for success of endodontic therapies. When evaluating&#xD;
      treatment results, a commission made up of three operators, all active members of the Italian&#xD;
      Endodontic Society (SIE), re-examined the radiograms and the clinical chart.&#xD;
&#xD;
      The bone loss/recovery due to the therapy of the fracture was radiographically evaluated at&#xD;
      the one year follow-up: using Adobe Photoshop, the area of the bone loss was drawn,&#xD;
      calculated and compared on radiograms at the moment of the diagnosis and at one year after&#xD;
      the treatment, using the same radiological projection and classified as recovered, same loss,&#xD;
      or further loss.&#xD;
&#xD;
      Radiographic examination was performed after the restoration, and then the radiographic&#xD;
      survey was repeated every six months for the first two years and once a year for the&#xD;
      remaining period.&#xD;
&#xD;
      These cases have all been reported, treated and evaluated over time by radiographic and&#xD;
      clinical investigation. In all treated cases, the protocol of adhesive restorations was the&#xD;
      same, performed and documented with the aid of the Leica 650 surgical microscope by the same&#xD;
      operator. The adhesive protocol (87 cases) remained unchanged over time (from 1991 to 2019).&#xD;
      A few cases (21 cases) were treated with amalgam, following protocols recommended by the&#xD;
      literature to avoid the risk of dental fractures (endo-canal retention and cusp covering).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 15, 1991</start_date>
  <completion_date type="Actual">December 19, 2019</completion_date>
  <primary_completion_date type="Actual">September 5, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Results</measure>
    <time_frame>from 1991 to 2019</time_frame>
    <description>Survival rate of teeth with vertical root fracture will be considered at one, three, five and more than five years, and a qualitative evaluation of the tooth will be given, clinically and radiographically:&#xD;
success: tooth is asymptomatic and there is not radiographc lesion;&#xD;
functional success: the tooth is asymptomatic but there is a radiographic lesion;&#xD;
failure: the tooth would be extracted because of symptoms and/or radiographic lesion getting worse;&#xD;
extracted: the tooth was extracted before the control visit.</description>
  </primary_outcome>
  <enrollment type="Actual">99</enrollment>
  <condition>Root; Fracture</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Adhesive restoration protocol</intervention_name>
    <description>The canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush.&#xD;
The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky.&#xD;
The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding.&#xD;
Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file.&#xD;
The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5&#xD;
        years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root&#xD;
        fracture&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Any patient with at least one tooth with a vertical root fracture&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        any patient who does not have at least one tooth with a vertical root fracture&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 5, 2020</study_first_submitted>
  <study_first_submitted_qc>June 10, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 12, 2020</study_first_posted>
  <last_update_submitted>June 10, 2020</last_update_submitted>
  <last_update_submitted_qc>June 10, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 12, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale</investigator_affiliation>
    <investigator_full_name>Fabrizio Zaccheo</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Fractures, Bone</mesh_term>
  </condition_browse>
  <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/NCT04430205
org study id: 2370CELazio1
nct id: NCT04430205
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim and background: The aim of this retrospective observational study is to evaluate the
      survival rate of cracked teeth, presenting partial (PVF) or complete vertical fracture (CVF),
      after tooth restoration either with fracture-fragment adhesive bonding or with amalgam
      restoration.

      Materials and Methods: One hundred eight fractured teeth, from 99 patients (51 males, 48
      females, mean age 50.5 years), presenting complete or partial root fracture, were treated
      with adhesive restoration or non-adhesive restoration protocol (amalgam) between 1991 and
      2019. Demographic and clinical variables were evaluated as predictors of extraction.
      Furthermore, the bone loss/recovery due to therapy for the fracture was radiographically
      evaluated at the one year follow-up. All cases were treated by the same operator, using a
      surgical microscope. Statistical analysis was performed with IBM SPSS Statistics. The study
      was approved by the ethical committee of Sistema Sanitario Nazionale (prot. N°2370CELazio1).
One hundred eight fractured teeth, from 99 patients (51 males, 48 females, mean age 50.5
      years, standard deviation (SD) 12.8, range 23-84), presenting complete or partial root
      fracture, were included in this observational retrospective study. All the teeth were treated
      according to one of two clinical protocols (adhesive or amalgam, see below). Besides a
      general medical history and subjective and objective symptoms, the presence of the crack was
      determined by the usage of a Leica 650 stereomicroscope with the help of methylene blue or
      eosin-type dyes. The following parameters were gathered from the clinical charts to evaluate
      possible risk factors for extraction: age, gender, tooth number and type of root fracture
      (complete or partial). A vitality test was performed with an electrical test, and periodontal
      probing was performed on six sites per tooth to detect probing defects, using a manual probe.
      Periapical radiolucency at the moment of the diagnosis, survival in months and type of
      coronal restoration at the diagnosis (no restoration, single crown, composite, amalgam) were
      all explored. Presence of calcification in the canal, endo-treatment before the diagnosis of
      fracture (no treatment, good endodontic treatment, surgical treatment, retreatment), canal
      obstacles (i.e., broken files) and previous endo-canal retention (no retention, screw post,
      fibre post, cast post, composite, amalgam) were all determined. Survival was also considered
      at one, three, five and more than five years, and a qualitative evaluation of the tooth was
      given (success, functional success: the tooth was asymptomatic; failure: the tooth would be
      extracted; extracted: the tooth was extracted before the control visit), modifying the
      European Society of Endodontology for success of endodontic therapies. When evaluating
      treatment results, a commission made up of three operators, all active members of the Italian
      Endodontic Society (SIE), re-examined the radiograms and the clinical chart.

      The bone loss/recovery due to the therapy of the fracture was radiographically evaluated at
      the one year follow-up: using Adobe Photoshop, the area of the bone loss was drawn,
      calculated and compared on radiograms at the moment of the diagnosis and at one year after
      the treatment, using the same radiological projection and classified as recovered, same loss,
      or further loss.

      Radiographic examination was performed after the restoration, and then the radiographic
      survey was repeated every six months for the first two years and once a year for the
      remaining period.

      These cases have all been reported, treated and evaluated over time by radiographic and
      clinical investigation. In all treated cases, the protocol of adhesive restorations was the
      same, performed and documented with the aid of the Leica 650 surgical microscope by the same
      operator. The adhesive protocol (87 cases) remained unchanged over time (from 1991 to 2019).
      A few cases (21 cases) were treated with amalgam, following protocols recommended by the
      literature to avoid the risk of dental fractures (endo-canal retention and cusp covering).
observational model: Cohort
time perspective: Retrospective
measure: Results
time frame: from 1991 to 2019
description: Survival rate of teeth with vertical root fracture will be considered at one, three, five and more than five years, and a qualitative evaluation of the tooth will be given, clinically and radiographically:
success: tooth is asymptomatic and there is not radiographc lesion;
functional success: the tooth is asymptomatic but there is a radiographic lesion;
failure: the tooth would be extracted because of symptoms and/or radiographic lesion getting worse;
extracted: the tooth was extracted before the control visit.
intervention type: Procedure
intervention name: Adhesive restoration protocol
description: The canal walls were etched with 37% orthophosphoric acid for 30 seconds with use of a microbrush.
The primer was applied on the wet canal walls, with a microbrush several times, after checking by drying the canal, that the appearance of the dentine was shiny and not opaque or chalky.
The next step was the application of bonding with a microbrush, blowing in the fracture line to make sure it is not loaded with bonding.
Flow composite was used to make it penetrate the fracture line with the help of a 0.06 mm k-file.
The canals were filled with dual composite parts more deeply, light cured at the canal entrance and pulp chamber; the following phase was the coronal restoration with a sandwich technique, covering the cusp with composite.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Centro di Ricerca Odonotiatrica e Corsi di Aggiornamento Professionale
investigator full name: Fabrizio Zaccheo
investigator title: Principal Investigator
mesh term: Fractures, Bone
sharing ipd: No