<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/NCT01728532</url>
  </required_header>
  <id_info>
    <org_study_id>11/001</org_study_id>
    <nct_id>NCT01728532</nct_id>
  </id_info>
  <brief_title>Open, Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer</brief_title>
  <acronym>PA0903</acronym>
  <official_title>Open, Randomized Multicentric Trial Evaluating the Efficacy and the Clinical Tolerance of PA0903 as Root Canal Sealer</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ascopharm Groupe Novasco</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Ascopharm Groupe Novasco</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical&#xD;
      tolerance of PA0903 as root canal sealer&#xD;
&#xD;
      SPONSOR:&#xD;
&#xD;
      SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33&#xD;
      1-49-76-74-26, Fax. : + 33 1- 49-76-71-91&#xD;
&#xD;
      Reference protocol: 11/001&#xD;
&#xD;
      PRODUCT NAME: PA0903&#xD;
&#xD;
      MEDICAL DEVICE:&#xD;
&#xD;
      Class III: Root canal sealer Dose: not applicable Application : one single time&#xD;
&#xD;
      DEVELOPMENTAL PHASE: not applicable (medical device class III)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      METHODOLOGY:&#xD;
&#xD;
      This study is performed only in adults who required a non-surgical root canal obturation. The&#xD;
      studied indication is the root canal sealing.&#xD;
&#xD;
      This multi-centre and open-label study comprises two groups corresponding to tested root&#xD;
      canal sealer (a reference product and investigational product). Randomization is required.&#xD;
&#xD;
      Investigational product that is a dental cement based on biosilicate technology (PA0903) will&#xD;
      be applied with lateral compaction or single cone technique. On the contrary, reference&#xD;
      product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be&#xD;
      applied with a single wave technique.&#xD;
&#xD;
      Study start: 01/12/11&#xD;
&#xD;
      Inclusion period: 24 months&#xD;
&#xD;
      Study duration: 2 years after the end of inclusion period&#xD;
&#xD;
      OBJECTIVES: The trial objective is to illustrate the clinical and radiographic outcome of&#xD;
      PA0903 in the described indication.&#xD;
&#xD;
      Primary objectives:&#xD;
&#xD;
      The primary objective is to evaluate: clinical and radiographic outcome of root canal&#xD;
      treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The&#xD;
      success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in&#xD;
      the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size&#xD;
      decrease associated with normal contours, width and structure of the periodontal margines is&#xD;
      considered as success. All cases in which lesion increases or is stabilized after 2 years&#xD;
      were judged as unsuccessful . Moreover, all cases in which Strindberg's criteria if they are&#xD;
      suitable were not fulfilled were judged as unsuccessful. A follow-up of two years is&#xD;
      described as the predictive time of success.&#xD;
&#xD;
      Secondary objective:&#xD;
&#xD;
      The secondary objectives are to evaluate the following criteria and in an indicative way, to&#xD;
      compare them between patients receiving the PA0903 and those receiving the reference product:&#xD;
&#xD;
      - The success rate at each time point and also the components of this composite variable&#xD;
      (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic&#xD;
      status of teeth).&#xD;
&#xD;
      In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable&#xD;
      Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as&#xD;
      described below :&#xD;
&#xD;
      At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in&#xD;
      comparison with V0 associated with Strindberg's criteria suitable.&#xD;
&#xD;
      At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with&#xD;
      V2 associated with Strindberg's criteria suitable.&#xD;
&#xD;
        -  the Healing process associated with PA0903 application in each endodontic status&#xD;
&#xD;
        -  the handling, consistency and physical characteristics of PA0903&#xD;
&#xD;
        -  the longevity and safety of the product associated with PA0903 after two years.&#xD;
&#xD;
      TRIAL POPULATION AND NUMBER OF PATIENTS: about 60 patients will have to be included in the&#xD;
      study, 20 by center with a ratio 2 (PA0903): 1 (reference). Adults will be included without&#xD;
      gender distinction.&#xD;
&#xD;
      Coordinating center Endodotontic service of Pitié Salpétrière Pitié Salpétrière Hospital&#xD;
      75634 Paris Cedex 13 France&#xD;
&#xD;
      DURATION OF TREATMENT:&#xD;
&#xD;
      The product is applied on D0 (inclusion) of the study. The follow-up period includes 2 years&#xD;
      with 4 visits: Visit 1(Week 2), Visit 2 (Month 6), Visit 3 (Year 1) and Visit 4 (Year 2).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>June 2012</start_date>
  <completion_date type="Actual">June 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical and radiographic outcome of PA0903 as root canal sealer</measure>
    <time_frame>2 years</time_frame>
    <description>to evaluate clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Secondary outcomes</measure>
    <time_frame>2 years</time_frame>
    <description>- The success rate at each time point and also the components of this composite variable (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).&#xD;
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :&#xD;
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.&#xD;
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.&#xD;
the Healing process associated with PA0903 application in each endodontic status&#xD;
the handling, consistency and physical characteristics of PA0903&#xD;
the longevity and safety of the product associated with PA0903 after two years.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">26</enrollment>
  <condition>Root Canal Obturation</condition>
  <arm_group>
    <arm_group_label>Pulp Canal Sealer (Kerr)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>zinc oxide eugenol sealer</description>
  </arm_group>
  <arm_group>
    <arm_group_label>PA0903</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>type C implant according to ISO 7405:2008 and ISO 10993 guidelines.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Pulp Canal Sealer (Kerr)</intervention_name>
    <description>permanent obturation of the root canal space with the aid of obturating points</description>
    <arm_group_label>Pulp Canal Sealer (Kerr)</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>PA0903</intervention_name>
    <description>Sealing performed by the dentist , coronal obturation placed after the canal obturation</description>
    <arm_group_label>PA0903</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria&#xD;
&#xD;
          -  Male or female &gt;18 years old&#xD;
&#xD;
          -  provide signed, informed consent.&#xD;
&#xD;
          -  be affiliated to social security.&#xD;
&#xD;
        In addition, the subjects must fulfill all of the following criteria for root canal sealer&#xD;
        treatment:&#xD;
&#xD;
          -  Permanent mature single rooted teeth : maxillary incisors, mandibular incisor with&#xD;
             only one canal, upper and lower canine, upper and lower premolars with only one canal&#xD;
&#xD;
          -  Permanent mature mandibular molars Pulp status&#xD;
&#xD;
          -  Vital pulp that needs pulpectomy without clinical and/or radiological findings of&#xD;
             apical periodontitis.&#xD;
&#xD;
          -  Irreversible pulpitis with or without pain&#xD;
&#xD;
          -  Non infected tooth that positively responds of pulp vitality test Or necrotic pulp&#xD;
             with and without radiographic signs of apical pathosis Periodontal status&#xD;
&#xD;
          -  No active periodontal disease&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
          -  History of malignancy in the last 5 years.&#xD;
&#xD;
          -  Systemic disease not stabilized within 1 month before the Inclusion Visit (e.g.,&#xD;
             diabetes, thyroid malfunction, uncontrolled autoimmune disease) or judged by the&#xD;
             investigator to be incompatible with the study (e.g. current systemic infections) or&#xD;
             condition incompatible with the frequent assessments needed by the study.&#xD;
&#xD;
          -  Risk A cardiopathies&#xD;
&#xD;
          -  Known hypersensitivity to one of the components of the study or procedural&#xD;
             medications.&#xD;
&#xD;
          -  Presence or history of severe systemic allergy.&#xD;
&#xD;
          -  Presence or history of drug addiction or alcohol abuse.&#xD;
&#xD;
          -  Patient who has participated in a clinical trial with a new active substance during&#xD;
             the month before study entry.&#xD;
&#xD;
          -  Participation in another clinical study at the same time as the present study.&#xD;
&#xD;
          -  Known pregnancy or lactation at study entry.&#xD;
&#xD;
          -  Patients with legal protection&#xD;
&#xD;
        Specific criteria relative to root canal sealing are:&#xD;
&#xD;
          -  Extreme curvature of the canals&#xD;
&#xD;
          -  Dilacerations&#xD;
&#xD;
          -  Root dilacerations and sharp apical curvature for mandibular molars&#xD;
&#xD;
          -  Superimposition of mesial canals for mandibular molar&#xD;
&#xD;
          -  Large peri-apical radiolucencies&#xD;
&#xD;
          -  Periodontal disease&#xD;
&#xD;
          -  Not primary endodontic treatment&#xD;
&#xD;
          -  Perforated root canals&#xD;
&#xD;
          -  Supracrestal iatrogenic perforation&#xD;
&#xD;
          -  Inadequate or insufficient periodontal support&#xD;
&#xD;
          -  Combined endo-periodontal lesion&#xD;
&#xD;
          -  Loss of tooth structure (Coronal decay and/or concomitant root decay) compromising the&#xD;
             tooth's maintenance on the dental arch)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Stéphane Simon, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hôpital Pitié Salpetrière, Paris, France</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Cabinet dentaire privé - 21, rue Fabre d'Églantine</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Service d'endodontie de la Pitié Salpêtrière Hôpital de la Pitié Salpêtrière</name>
      <address>
        <city>Paris</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>School of Dentistry Cardiff University</name>
      <address>
        <city>Cardiff</city>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 6, 2012</study_first_submitted>
  <study_first_submitted_qc>November 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 20, 2012</study_first_posted>
  <last_update_submitted>November 30, 2016</last_update_submitted>
  <last_update_submitted_qc>November 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 1, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01728532
org study id: 11/001
nct id: NCT01728532
lead sponsor: 
has dmc: Yes
TRIAL TITLE: Open, randomized multicentric trial evaluating the efficacy and the clinical
      tolerance of PA0903 as root canal sealer

      SPONSOR:

      SEPTODONT, 58 rue du Pont de Créteil, 94107 Saint Maur des Fossés cedex Tel : + 33
      1-49-76-74-26, Fax. : + 33 1- 49-76-71-91

      Reference protocol: 11/001

      PRODUCT NAME: PA0903

      MEDICAL DEVICE:

      Class III: Root canal sealer Dose: not applicable Application : one single time

      DEVELOPMENTAL PHASE: not applicable (medical device class III)
METHODOLOGY:

      This study is performed only in adults who required a non-surgical root canal obturation. The
      studied indication is the root canal sealing.

      This multi-centre and open-label study comprises two groups corresponding to tested root
      canal sealer (a reference product and investigational product). Randomization is required.

      Investigational product that is a dental cement based on biosilicate technology (PA0903) will
      be applied with lateral compaction or single cone technique. On the contrary, reference
      product that is a zinc oxide-eugenol used in dental practice (Pulp Canal Sealer) will be
      applied with a single wave technique.

      Study start: 01/12/11

      Inclusion period: 24 months

      Study duration: 2 years after the end of inclusion period

      OBJECTIVES: The trial objective is to illustrate the clinical and radiographic outcome of
      PA0903 in the described indication.

      Primary objectives:

      The primary objective is to evaluate: clinical and radiographic outcome of root canal
      treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The
      success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in
      the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size
      decrease associated with normal contours, width and structure of the periodontal margines is
      considered as success. All cases in which lesion increases or is stabilized after 2 years
      were judged as unsuccessful . Moreover, all cases in which Strindberg's criteria if they are
      suitable were not fulfilled were judged as unsuccessful. A follow-up of two years is
      described as the predictive time of success.

      Secondary objective:

      The secondary objectives are to evaluate the following criteria and in an indicative way, to
      compare them between patients receiving the PA0903 and those receiving the reference product:

      - The success rate at each time point and also the components of this composite variable
      (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic
      status of teeth).

      In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable
      Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as
      described below :

      At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in
      comparison with V0 associated with Strindberg's criteria suitable.

      At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with
      V2 associated with Strindberg's criteria suitable.

        -  the Healing process associated with PA0903 application in each endodontic status

        -  the handling, consistency and physical characteristics of PA0903

        -  the longevity and safety of the product associated with PA0903 after two years.

      TRIAL POPULATION AND NUMBER OF PATIENTS: about 60 patients will have to be included in the
      study, 20 by center with a ratio 2 (PA0903): 1 (reference). Adults will be included without
      gender distinction.

      Coordinating center Endodotontic service of Pitié Salpétrière Pitié Salpétrière Hospital
      75634 Paris Cedex 13 France

      DURATION OF TREATMENT:

      The product is applied on D0 (inclusion) of the study. The follow-up period includes 2 years
      with 4 visits: Visit 1(Week 2), Visit 2 (Month 6), Visit 3 (Year 1) and Visit 4 (Year 2).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical and radiographic outcome of PA0903 as root canal sealer
time frame: 2 years
description: to evaluate clinical and radiographic outcome of root canal treatment at two years when using PA0903 as an endodontic sealer with gutta-percha. The success rate is defined as no pain (score of 0 at the VAS scale) and absence or decrease in the size of LEO (fulfilment of Strindberg's criteria). If a pre-existing lesion, the size decrease associated with normal contours, width and structure of the periodontal margines is considered as success. All cases in which lesion increases or is stabilized after 2 years were judged as unsuccessful .A follow-up of two years is described as the predictive time of success.
measure: Secondary outcomes
time frame: 2 years
description: - The success rate at each time point and also the components of this composite variable (i.e. pain and Healing process for total class (vital teeth and necrotic teeth) of endodontic status of teeth).
In case of pre-existing LEO associated with necrotic teeth, size of LEO and suitable Strindgberg's criteria will be used to judge the outcomes of the root canal therapy as described below :
At visit 2 (6 months) treatment is considered successful when LEO is stable or decreased in comparison with V0 associated with Strindberg's criteria suitable.
At V3 (1 year), treatment is considered successful when LEO is decreased in comparison with V2 associated with Strindberg's criteria suitable.
the Healing process associated with PA0903 application in each endodontic status
the handling, consistency and physical characteristics of PA0903
the longevity and safety of the product associated with PA0903 after two years.
arm group label: Pulp Canal Sealer (Kerr)
arm group type: Active Comparator
description: zinc oxide eugenol sealer
arm group label: PA0903
arm group type: Experimental
description: type C implant according to ISO 7405:2008 and ISO 10993 guidelines.
intervention type: Device
intervention name: Pulp Canal Sealer (Kerr)
description: permanent obturation of the root canal space with the aid of obturating points
arm group label: Pulp Canal Sealer (Kerr)
intervention type: Device
intervention name: PA0903
description: Sealing performed by the dentist , coronal obturation placed after the canal obturation
arm group label: PA0903
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Stéphane Simon, PhD
role: Principal Investigator
affiliation: Hôpital Pitié Salpetrière, Paris, France
facility: 
facility: 
facility: 
country: France
country: United Kingdom
responsible party type: Sponsor