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/NCT05965076</url>
    </required_header>
    <id_info>
      <org_study_id>99110619</org_study_id>
      <nct_id>NCT05965076</nct_id>
    </id_info>
    <brief_title>Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM</brief_title>
    <official_title>Analysis of the Effectiveness of the Use of Glycine Powder and Angled Implant Brush in Oral Hygiene Maintenance in Patients Reinstated With Columbus Bridge ProtocolTM: a Factorial Randomized Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Azienda Ospedaliera Città della Salute e della Scienza di Torino</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Azienda Ospedaliera Città della Salute e della Scienza di Torino</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>
        This study aims at comparing different procedures of Professional Oral Hygiene (POH) and&#xD;
        Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by&#xD;
        dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients&#xD;
        will randomly be assigned to a &quot;Standard&quot; or &quot;Glycine Perio Flow&quot; Professional treatment, and&#xD;
        to a &quot;Standard&quot; or &quot;Angled&quot; Toothbrush for their Domiciliary oral hygiene.&#xD;
  &#xD;
        Data about bacterial plaque presence is collected both before and after unscrewing the&#xD;
        denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected&#xD;
        after unscrewing the denture, by means of erythrosine and analyzed using a specific software&#xD;
        that allows to compute the percentage of plaque on the denture.&#xD;
  &#xD;
        Patients will be seen after 3 months in order to figure out differences between DOH groups,&#xD;
        by measuring plaque on abutments and on the denture after unscrewing it.&#xD;
  &#xD;
        At the moment there are no scientific studies trying to determine which professional and&#xD;
        domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge&#xD;
        ProtocolTM reinstated patients.&#xD;
  &#xD;
        Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are&#xD;
        expected in patients treated with glycine perio flow, compared to standard treated patients.&#xD;
        However, when it comes to angled toothbrush, lower PI and DPI are expected not to be&#xD;
        statistically significant.&#xD;
  &#xD;
        Expectation from this study is to get information on how to improve full-arch patients'&#xD;
        therapy in order to reduce peri-implant diseases which are related to bacterial plaque.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">February 6, 2023</start_date>
    <completion_date type="Anticipated">September 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2024</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>Factorial Assignment</intervention_model>
      <primary_purpose>Prevention</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Denture Plaque Index (DPI)</measure>
      <time_frame>T0: first session (for professional oral hygiene).</time_frame>
      <description>This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).&#xD;
  Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Denture Plaque Index (DPI)</measure>
      <time_frame>T1: second session, after 3 months (for domiciliary oral hygiene).</time_frame>
      <description>This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).&#xD;
  Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Probing Depth (PD);</measure>
      <time_frame>T0: first session (for professional oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Probing Depth (PD);</measure>
      <time_frame>T1: second session, after 3 months (for domiciliary oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on Probing (BoP);</measure>
      <time_frame>T0: first session (for professional oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bleeding on Probing (BoP);</measure>
      <time_frame>T1: second session, after 3 months (for domiciliary oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque Index on implant abutments</measure>
      <time_frame>T0: first session (for professional oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Plaque Index on implant abutments</measure>
      <time_frame>T1: second session, after 3 months (for domiciliary oral hygiene).</time_frame>
      <description>Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">74</enrollment>
    <condition>Plaque, Dental</condition>
    <arm_group>
      <arm_group_label>Standard</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Glycine</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Angled toothbrush</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Glycine - Angled toothbrush</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Glycine Perio Flow</intervention_name>
      <description>Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.</description>
      <arm_group_label>Glycine</arm_group_label>
      <arm_group_label>Glycine - Angled toothbrush</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Angled Toothbrush</intervention_name>
      <description>Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.</description>
      <arm_group_label>Angled toothbrush</arm_group_label>
      <arm_group_label>Glycine - Angled toothbrush</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Standard Professional Oral Hygiene</intervention_name>
      <description>Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.</description>
      <arm_group_label>Angled toothbrush</arm_group_label>
      <arm_group_label>Standard</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Behavioral</intervention_type>
      <intervention_name>Standard Domiciliary Oral Hygiene</intervention_name>
      <description>Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.</description>
      <arm_group_label>Glycine</arm_group_label>
      <arm_group_label>Standard</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age &gt;= 18years&#xD;
  &#xD;
            -  Good systemic health, with ASA classification &lt;= 2&#xD;
  &#xD;
            -  Columbus Bridge ProtocolTM reinstation from at least six months&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Heavy smokers (&gt;= 10 cigarettes per day)&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Autoimmune diseases with or without oral involvement&#xD;
  &#xD;
            -  Biological complications on at least one of the dental implants&#xD;
  &#xD;
            -  Perimplantits diagnosis, defined according to Lindhe et al's criteria [5]&#xD;
  &#xD;
            -  Radicular bone &lt;4mm, evaluated by means of RX&#xD;
  &#xD;
            -  Use of gingival overgrowth inducing drugs&#xD;
  &#xD;
            -  Cognitive or motor impairments&#xD;
  &#xD;
            -  Full-arch reinstations performed in other structures&#xD;
  &#xD;
            -  Respiratory issues&#xD;
  &#xD;
            -  Infective diseases&#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>
    <overall_contact>
      <last_name>Armando Crupi, Dr.</last_name>
      <phone>+39 0116331531</phone>
      <email>armando.crupi@unito.it</email>
    </overall_contact>
    <location>
      <facility>
        <name>S.C. Riabilitazione Orale Protesi Maxillo-Facciale e Implantologia Dentaria</name>
        <address>
          <city>Torino</city>
          <zip>10126</zip>
          <country>Italy</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Armando Crupi, Dr.</last_name>
        <phone>+39 0116331531</phone>
        <email>armando.crupi@unito.it</email>
      </contact>
      <contact_backup>
        <last_name>Jacopo Lanzetti, Dr.</last_name>
        <phone>+39 0116331531</phone>
        <email>jacopo.lanzetti@unito.it</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>Italy</country>
    </location_countries>
    <results_reference>
      <citation>Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.</citation>
      <PMID>18724855</PMID>
    </results_reference>
    <results_reference>
      <citation>Abi Nader S, Eimar H, Momani M, Shang K, Daniel NG, Tamimi F. Plaque Accumulation Beneath Maxillary All-on-4 Implant-Supported Prostheses. Clin Implant Dent Relat Res. 2015 Oct;17(5):932-7. doi: 10.1111/cid.12199. Epub 2014 Jan 27.</citation>
      <PMID>24461161</PMID>
    </results_reference>
    <results_reference>
      <citation>Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.</citation>
      <PMID>32348624</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 6, 2023</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 28, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Azienda Ospedaliera Città della Salute e della Scienza di Torino</investigator_affiliation>
      <investigator_full_name>Crupi Armando</investigator_full_name>
      <investigator_title>Principal investigator</investigator_title>
    </responsible_party>
    <keyword>glycine</keyword>
    <keyword>airflow</keyword>
    <keyword>full-arch</keyword>
    <keyword>angled toothbrush</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Plaque</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Glycine</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05965076
  org study id: 99110619
  nct id: NCT05965076
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  This study aims at comparing different procedures of Professional Oral Hygiene (POH) and
        Domiciliary Oral Hygiene (DOH) in Columbus Bridge ProtocolTM full-arch reinstated patients by
        dividing a sample of at least 74 patients into 4 groups with a 1:1:1:1 ratio. The patients
        will randomly be assigned to a "Standard" or "Glycine Perio Flow" Professional treatment, and
        to a "Standard" or "Angled" Toothbrush for their Domiciliary oral hygiene.
  
        Data about bacterial plaque presence is collected both before and after unscrewing the
        denture, when it comes to implant abutments. Instead, Denture Plaque Index will be collected
        after unscrewing the denture, by means of erythrosine and analyzed using a specific software
        that allows to compute the percentage of plaque on the denture.
  
        Patients will be seen after 3 months in order to figure out differences between DOH groups,
        by measuring plaque on abutments and on the denture after unscrewing it.
  
        At the moment there are no scientific studies trying to determine which professional and
        domiciliary procedures might be more efficient to control bacterial plaque in Columbus Bridge
        ProtocolTM reinstated patients.
  
        Statistically significant lower Plaque Index (PI) and Denture Plaque Index (DPI) scores are
        expected in patients treated with glycine perio flow, compared to standard treated patients.
        However, when it comes to angled toothbrush, lower PI and DPI are expected not to be
        statistically significant.
  
        Expectation from this study is to get information on how to improve full-arch patients'
        therapy in order to reduce peri-implant diseases which are related to bacterial plaque.
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Prevention
  masking: None (Open Label)
  measure: Denture Plaque Index (DPI)
  time frame: T0: first session (for professional oral hygiene).
  description: This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).
  Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
  measure: Denture Plaque Index (DPI)
  time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
  description: This study's primary outcome is the plaque index on the denture (DPI). Plaque indexes will be determined by means of erythrosine (GC Tri Plaque ID GelTM, Tokyo, Japan).
  Pictures in jpg format will be taken with a digital Nikon D80 camera with 105mm macro lens and processed with ImageJ 1.45s software (National Institutes of Health, Bethesda, MD, USA). Pictures will be converted into binary monochrome images. Specific standard thresholds will be determined to differentiate the plaque pixels (blue) from the plaque free ones (pink). This procedure is already proven by literature.
  measure: Probing Depth (PD);
  time frame: T0: first session (for professional oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.
  measure: Probing Depth (PD);
  time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Probing depth is evaluated in mm.
  measure: Bleeding on Probing (BoP);
  time frame: T0: first session (for professional oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).
  measure: Bleeding on Probing (BoP);
  time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. Bleeding on probing is evaluated as presence of bleeding (yes/no).
  measure: Plaque Index on implant abutments
  time frame: T0: first session (for professional oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.
  measure: Plaque Index on implant abutments
  time frame: T1: second session, after 3 months (for domiciliary oral hygiene).
  description: Periodontal indexes will be determined on four areas for each implant by means of a UNC 15 (Hu-Friedy, Chicago, IL, USA) Probe. PI is defined as plaque presence (yes/no) on the abutment or denture by means of erythrosine gel.
  arm group label: Standard
  arm group type: Active Comparator
  description: Patients will be professionally treated with standard dental hygiene treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.
  arm group label: Glycine
  arm group type: Experimental
  description: Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use a standard toothbrush for their domiciliary oral hygiene.
  arm group label: Angled toothbrush
  arm group type: Experimental
  description: Patients will be professionally treated with standard dental hygiene treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.
  arm group label: Glycine - Angled toothbrush
  arm group type: Experimental
  description: Patients will be professionally treated by adding glycine perio-flow in the treatment, and they will use an angled toothbrush for their domiciliary oral hygiene.
  intervention type: Procedure
  intervention name: Glycine Perio Flow
  description: Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss and glycine perio-flow.
  arm group label: Glycine
  arm group label: Glycine - Angled toothbrush
  intervention type: Behavioral
  intervention name: Angled Toothbrush
  description: Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and an angled toothbrush.
  arm group label: Angled toothbrush
  arm group label: Glycine - Angled toothbrush
  intervention type: Procedure
  intervention name: Standard Professional Oral Hygiene
  description: Professional plaque and tartar removal by means of titanium curettes, bridge and implant floss.
  arm group label: Angled toothbrush
  arm group label: Standard
  intervention type: Behavioral
  intervention name: Standard Domiciliary Oral Hygiene
  description: Patients will be educated and motivated in domiciliary oral hygien by means of bridge and implant floss and a standard toothbrush.
  arm group label: Glycine
  arm group label: Standard
  criteria: 
  gender: All
  minimum age: N/A
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Armando Crupi, Dr.
  phone: +39 0116331531
  email: armando.crupi@unito.it
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: Italy
  citation: Lindhe J, Meyle J; Group D of European Workshop on Periodontology. Peri-implant diseases: Consensus Report of the Sixth European Workshop on Periodontology. J Clin Periodontol. 2008 Sep;35(8 Suppl):282-5. doi: 10.1111/j.1600-051X.2008.01283.x.
  PMID: 18724855
  citation: Abi Nader S, Eimar H, Momani M, Shang K, Daniel NG, Tamimi F. Plaque Accumulation Beneath Maxillary All-on-4 Implant-Supported Prostheses. Clin Implant Dent Relat Res. 2015 Oct;17(5):932-7. doi: 10.1111/cid.12199. Epub 2014 Jan 27.
  PMID: 24461161
  citation: Mensi M, Scotti E, Sordillo A, Agosti R, Calza S. Plaque disclosing agent as a guide for professional biofilm removal: A randomized controlled clinical trial. Int J Dent Hyg. 2020 Aug;18(3):285-294. doi: 10.1111/idh.12442. Epub 2020 May 26.
  PMID: 32348624
  responsible party type: Principal Investigator
  investigator affiliation: Azienda Ospedaliera Città della Salute e della Scienza di Torino
  investigator full name: Crupi Armando
  investigator title: Principal investigator
  mesh term: Dental Plaque
  mesh term: Glycine
  sharing ipd: Yes