<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/NCT03256409</url>
  </required_header>
  <id_info>
    <org_study_id>Gastrovital&amp;Development</org_study_id>
    <nct_id>NCT03256409</nct_id>
  </id_info>
  <brief_title>Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence</brief_title>
  <official_title>Bar and Ball Joint Overdentures Surface Roughness and Microbial Adherence</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gastrovital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gastrovital</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>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the study was to compare the surface roughness (Ra) of the implant retained&#xD;
      mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture&#xD;
      (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in&#xD;
      time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental&#xD;
      Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball&#xD;
      Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two&#xD;
      parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days&#xD;
      they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo&#xD;
      Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).&#xD;
&#xD;
      The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and&#xD;
      yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll&#xD;
      aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD,&#xD;
      present different Ra (P &lt; 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not&#xD;
      exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both&#xD;
      overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and&#xD;
      yeast and mesophyll aerobe, being major in BJOD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Adherence mold and yeast and mesophyll aerobe to BOD and BJOD, Surface roughness (Ra), and&#xD;
      Statistical Analyses Microbial populations have been controlled in the saliva at initial time&#xD;
      and adherence at 30 to 180 days after the overdentures in the mouth. The saliva sample was&#xD;
      obtained from the patient in a sterile sputum collection bottle through a sterile solution.&#xD;
      The overdenture samples were extracted and processed for analysis. Each sample was submerged&#xD;
      in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial&#xD;
      suspensions, successive dilutions were made to determine the total number of viable&#xD;
      microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe&#xD;
      were performed.&#xD;
&#xD;
      The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo&#xD;
      Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of&#xD;
      4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness&#xD;
      profile Ra was evaluated and determined in microns (ųm) through five readings for each of the&#xD;
      samples in the study respectively.&#xD;
&#xD;
      The results of BOD and BJOD were compared for the determination of Ra and the adherence of&#xD;
      mold and yeast and mesophyll aerobe. For this, we used the statistics Shapiro-Wilk, T and the&#xD;
      Pearson Correlation Coefficient to determinate the relationship between the study variables.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 5, 2016</start_date>
  <completion_date type="Actual">June 20, 2017</completion_date>
  <primary_completion_date type="Actual">January 11, 2017</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>The study presents the results of a sample of ten patients randomly assigned to receive implant-retained overdentures and divided into two parallel groups of five participants in a single-blind trial at a follow-up period of 30 - 180 days permanence in the mouth. Five overdentures were made for each group: Group 1: BOD: five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (BOD). Group 2: BJOD: five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra were used in two parallel groups of five participants, in an essay to simple blind person.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>The working protocol for determining the BOD Ra and BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator and the following working methodology was considered: Information to the patient and obtainment of clinical data and patient informed consent. Patients were randomly assigned to group 1 and group 2. The saliva sample was obtained in each patient for the microbiological before the installation of the overdentures. BODs and BJODs were installed in each patient and according to each case. The BOD and BJOD were removed at 30 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml). For the study at 180 days the BODs and the BJODs were installed in each patient. BODs and BJODs were removed after this time to proceed to the evaluation of surface roughness and adhesion of mold and yeast and mesophyll aerobe under the same parameters mentioned above.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Average values of surface roughness (Ra) and correlation of independent test in implant-retained mandibular bar overdentures (BOD) 30 - 180 days.</measure>
    <time_frame>Change from 30 to 180 days</time_frame>
    <description>The average Ra Group 1: BOD titanium bar CARES® and synOcta Straumann® in 30 days: 0.965um. In 180 days: 1.351um. 95% confidence and Shapiro Wilk (P &gt; 0.05), determines normal distribution. Correlation of independent test (P &lt; 0.05) 30 days (P= 0.000) and 180 days (P=0.001) determined different Ra. Ll: Lower limit; Ul: Upper limit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Average values of surface roughness (Ra) and correlation of independents tests in implant-retained ball joint overdentures (BJOD) 30 - 180 days.</measure>
    <time_frame>Change from 30 to 180 days</time_frame>
    <description>The average Ra Group 2: BJOD Klockner® in 30 days: 1.325um. 180 days: 2.384 um. 95% confidence and Shapiro Wilk (P &gt; 0.05), determines normal distribution. Correlation of independent test (P &lt; 0.05) 30 days (P=0.000) and 180 days (P=0.000) determined different Ra. Ll: Lower limit; Ul: Upper limit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Average values of mold and yeast adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days</measure>
    <time_frame>Change from 30 to 180 days</time_frame>
    <description>Average adhesion values of mold and yeast. Group 1 (BOD): 30 days: 2.6 x 102 CFU/ml. Group 2 (BJOD): 30 days: 3.0 x 102 CFU/ml. Group 1 (BOD): 180 days: 4.6 x 103 CFU/ml. Group 2 (BJOD): 180 days: 5.3 x 104 CFU/ml. 95% confidence and Shapiro Wilk (P &gt; 0.05), determines normal distribution. Correlation of independent tests 30 days (P &gt; 0.05) BOD (P=0.051) y BJOD (P=0.052) showed no different adherence. For 180 days (P &lt; 0.05) BOD (P=0.025) y BJOD (P=0.027) presented different adhesion. Ll: Lower limit; Ul: Upper limit</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Average values of mesophyll aerobe adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days</measure>
    <time_frame>Change from 30 to 180 days</time_frame>
    <description>Average adhesion values of mesophyll aerobe. Group 1 (BOD): 30 days: 3.8 x 106 CFU/ml. Group 2 (BJOD): 30 days: 4.3 x 106 CFU/ml. Group 1 (BOD): 180 days: 5.8 x 106 CFU/ml. Group 2 (BJOD): 180 days: 7.1 x 107 CFU/ml. 95% confidence and Shapiro Wilk (P &gt; 0.05), determines normal distribution. Correlation of independent tests 30 days (P &gt; 0.05) BOD (P=0.052) y BJOD (P=0.053) showed no different adherence. For 180 days (P &lt; 0.05) BOD (P=0.000) y BJOD (P=0.000) presented different adhesion. Ll: Lower limit; Ul: Upper limit.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Adhesiveness</condition>
  <arm_group>
    <arm_group_label>Five Bar overdenture: BOD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (Bar overdenture: Group 1) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 1. The BOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Five Ball Joint Overdenture: BJOD</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra (Ball Joint Overdenture: Group 2) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 2. The s BJOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Adherence mold and yeast and mesophyll aerobe</intervention_name>
    <description>Adherence mold and yeast and mesophyll aerobe to BOD and BJOD Microbial populations have been controlled in the saliva at initial time and adherence at 30 - 180 days after the overdentures in the mouth. The saliva sample was obtained from the patient in a sterile sputum collection bottle through a sterile solution. The overdenture samples were extracted and processed for analysis. Each sample was submerged in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial suspensions, successive dilutions were made to determine the total number of viable microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe were performed.</description>
    <arm_group_label>Five Ball Joint Overdenture: BJOD</arm_group_label>
    <arm_group_label>Five Bar overdenture: BOD</arm_group_label>
    <other_name>Five BOD and Five BJOD</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Surface Roughness (Ra)</intervention_name>
    <description>The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of 4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness profile Ra was evaluated and determined in microns (ųm) through five readings for each of the samples in the study respectively.</description>
    <arm_group_label>Five Ball Joint Overdenture: BJOD</arm_group_label>
    <arm_group_label>Five Bar overdenture: BOD</arm_group_label>
    <other_name>Five BOD and Five BJOD</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Total edentulous mandible from 50 to 60 years of age&#xD;
&#xD;
          -  Absence of systemic conditions.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hyperplasia and history of periodontal disease&#xD;
&#xD;
          -  Patients with local and/or systemic antimicrobial treatment within 72 hours prior to&#xD;
             evaluation during the study&#xD;
&#xD;
          -  Signs of severe oral parafunction&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>50 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rocío Violeta Valenzuela-Narváez, PhD DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>CONCYTEC</affiliation>
  </overall_official>
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  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 22, 2017</study_first_posted>
  <last_update_submitted>August 19, 2017</last_update_submitted>
  <last_update_submitted_qc>August 19, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gastrovital</investigator_affiliation>
    <investigator_full_name>Valenzuela-Narváez Rocío Violeta</investigator_full_name>
    <investigator_title>PhD DDS</investigator_title>
  </responsible_party>
  <keyword>biomaterials</keyword>
  <keyword>methacrylates</keyword>
  <keyword>microbiology</keyword>
  <keyword>implant dentistry/implantology</keyword>
  <keyword>removable prosthodontics</keyword>
  <keyword>clinical studies/trials</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03256409/Prot_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Statistical Analysis Plan</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>January 5, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03256409/SAP_001.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>January 11, 2016</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/09/NCT03256409/ICF_002.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03256409
org study id: Gastrovital&Development
nct id: NCT03256409
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: Yes
The aim of the study was to compare the surface roughness (Ra) of the implant retained
      mandibular bar overdenture (BOD) and the implant retained mandibular ball joint overdenture
      (BJOD) in jaw and its relation with the adhesion of molds and yeasts and mesophyll aerobe, in
      time 30 to 180 days in mouth. Five systems titanium bar CARES® and synOcta® Straumann® Dental
      Implant System, Holding AG Inc., Basel, Switzerland (BOD); and five systems joint ball
      Klockner® Implant System; Soadco Inc., Escaldes-Engordany; Andorra (BJOD), were used in two
      parallel groups of five participants, in an essay to simple blind person. To 30 to 180 days
      they were withdrawn and they were evaluated the Ra (Mitutoyo Surfest SJ-301® Mitutoyo
      Corporation Inc., Kanagawa, Japan) and the adhesion of microorganisms (CFU/ml).

      The Ra:um (the 30th and 180th): BOD, 0.965 - 1.351; BJOD, 1.325 - 2.384. Adhesion: molds and
      yeasts, BOD, 2.6 x 102 and 4.6 x 103; BJOD, 3.0 x 102 and 5.3 x 104. Adhesion: mesophyll
      aerobe, BOD, 3.8 x 106 and 5.8 x 106; BJOD, 4.3 x 106 and 7.1 x 107. The BOD and BJOD,
      present different Ra (P < 0.05) to 30 to 180 days. To 30 days (P = 0.489) differences do not
      exist as regards the adhesion of molds and yeasts and mesophyll aerobe between both
      overdentures. To 180 days (P = 0.723) differences exist as regards the adhesion of mold and
      yeast and mesophyll aerobe, being major in BJOD.
Adherence mold and yeast and mesophyll aerobe to BOD and BJOD, Surface roughness (Ra), and
      Statistical Analyses Microbial populations have been controlled in the saliva at initial time
      and adherence at 30 to 180 days after the overdentures in the mouth. The saliva sample was
      obtained from the patient in a sterile sputum collection bottle through a sterile solution.
      The overdenture samples were extracted and processed for analysis. Each sample was submerged
      in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial
      suspensions, successive dilutions were made to determine the total number of viable
      microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe
      were performed.

      The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo
      Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of
      4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness
      profile Ra was evaluated and determined in microns (ųm) through five readings for each of the
      samples in the study respectively.

      The results of BOD and BJOD were compared for the determination of Ra and the adherence of
      mold and yeast and mesophyll aerobe. For this, we used the statistics Shapiro-Wilk, T and the
      Pearson Correlation Coefficient to determinate the relationship between the study variables.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study presents the results of a sample of ten patients randomly assigned to receive implant-retained overdentures and divided into two parallel groups of five participants in a single-blind trial at a follow-up period of 30 - 180 days permanence in the mouth. Five overdentures were made for each group: Group 1: BOD: five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (BOD). Group 2: BJOD: five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra were used in two parallel groups of five participants, in an essay to simple blind person.
primary purpose: Treatment
masking: Single (Investigator)
masking description: The working protocol for determining the BOD Ra and BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator and the following working methodology was considered: Information to the patient and obtainment of clinical data and patient informed consent. Patients were randomly assigned to group 1 and group 2. The saliva sample was obtained in each patient for the microbiological before the installation of the overdentures. BODs and BJODs were installed in each patient and according to each case. The BOD and BJOD were removed at 30 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml). For the study at 180 days the BODs and the BJODs were installed in each patient. BODs and BJODs were removed after this time to proceed to the evaluation of surface roughness and adhesion of mold and yeast and mesophyll aerobe under the same parameters mentioned above.
measure: Average values of surface roughness (Ra) and correlation of independent test in implant-retained mandibular bar overdentures (BOD) 30 - 180 days.
time frame: Change from 30 to 180 days
description: The average Ra Group 1: BOD titanium bar CARES® and synOcta Straumann® in 30 days: 0.965um. In 180 days: 1.351um. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent test (P < 0.05) 30 days (P= 0.000) and 180 days (P=0.001) determined different Ra. Ll: Lower limit; Ul: Upper limit.
measure: Average values of surface roughness (Ra) and correlation of independents tests in implant-retained ball joint overdentures (BJOD) 30 - 180 days.
time frame: Change from 30 to 180 days
description: The average Ra Group 2: BJOD Klockner® in 30 days: 1.325um. 180 days: 2.384 um. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent test (P < 0.05) 30 days (P=0.000) and 180 days (P=0.000) determined different Ra. Ll: Lower limit; Ul: Upper limit.
measure: Average values of mold and yeast adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days
time frame: Change from 30 to 180 days
description: Average adhesion values of mold and yeast. Group 1 (BOD): 30 days: 2.6 x 102 CFU/ml. Group 2 (BJOD): 30 days: 3.0 x 102 CFU/ml. Group 1 (BOD): 180 days: 4.6 x 103 CFU/ml. Group 2 (BJOD): 180 days: 5.3 x 104 CFU/ml. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent tests 30 days (P > 0.05) BOD (P=0.051) y BJOD (P=0.052) showed no different adherence. For 180 days (P < 0.05) BOD (P=0.025) y BJOD (P=0.027) presented different adhesion. Ll: Lower limit; Ul: Upper limit
measure: Average values of mesophyll aerobe adhesion and correlation of independents tests in implant-retained mandibular bar overdentures (BOD) and implant-retained mandibular ball joint overdentures (BJOD) 30 - 180 days
time frame: Change from 30 to 180 days
description: Average adhesion values of mesophyll aerobe. Group 1 (BOD): 30 days: 3.8 x 106 CFU/ml. Group 2 (BJOD): 30 days: 4.3 x 106 CFU/ml. Group 1 (BOD): 180 days: 5.8 x 106 CFU/ml. Group 2 (BJOD): 180 days: 7.1 x 107 CFU/ml. 95% confidence and Shapiro Wilk (P > 0.05), determines normal distribution. Correlation of independent tests 30 days (P > 0.05) BOD (P=0.052) y BJOD (P=0.053) showed no different adherence. For 180 days (P < 0.05) BOD (P=0.000) y BJOD (P=0.000) presented different adhesion. Ll: Lower limit; Ul: Upper limit.
arm group label: Five Bar overdenture: BOD
arm group type: Experimental
description: Five systems titanium bar CARES® and synOcta® Straumann® Dental Implant System, Holding AG Inc., Basel, Switzerland (Bar overdenture: Group 1) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 1. The BOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).
arm group label: Five Ball Joint Overdenture: BJOD
arm group type: Experimental
description: Five systems ball joint Klockner® Implant System; Soadco Inc., Escaldes-Engordany, Andorra (Ball Joint Overdenture: Group 2) For the manufacture of the overdentures it was used as material of choice Lucitone 199® (Dentsply International Inc. York, PA) and for the adaptation of the retention systems it was used Softreliner Tough Soft® Tocuyama Dental Corporation Inc., Japan. The working protocol for determining the BJOD Ra and the adhesion of molds and yeasts and mesophyll aerobics was carried out entirely by an investigator. Patients were randomly assigned to group 2. The s BJOD were removed at 30 - 180 days for surface roughness evaluation (Ra:ųm) and the evaluation of the adhesion of mold and yeast and mesophyll aerobe (CFU/ml).
intervention type: Other
intervention name: Adherence mold and yeast and mesophyll aerobe
description: Adherence mold and yeast and mesophyll aerobe to BOD and BJOD Microbial populations have been controlled in the saliva at initial time and adherence at 30 - 180 days after the overdentures in the mouth. The saliva sample was obtained from the patient in a sterile sputum collection bottle through a sterile solution. The overdenture samples were extracted and processed for analysis. Each sample was submerged in ¼ sterile Ringer and subjected to vigorous ultrasound shaking. From each of the microbial suspensions, successive dilutions were made to determine the total number of viable microorganisms present. Total count of mold and yeast and total count of mesophyll aerobe were performed.
arm group label: Five Ball Joint Overdenture: BJOD
arm group label: Five Bar overdenture: BOD
other name: Five BOD and Five BJOD
intervention type: Other
intervention name: Surface Roughness (Ra)
description: The surface roughness of BOD and BJOD was determined with the rugosimeter the Mitutoyo Surfest SJ-301® (Mitutoyo Corporation Inc., Kanagawa, Japan), through a displacement force of 4mN and of the tray to 0.5 mm/s and back to 1 mm/s (Murtra and Arcís,1999). The roughness profile Ra was evaluated and determined in microns (ųm) through five readings for each of the samples in the study respectively.
arm group label: Five Ball Joint Overdenture: BJOD
arm group label: Five Bar overdenture: BOD
other name: Five BOD and Five BJOD
criteria: 
gender: All
minimum age: 50 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rocío Violeta Valenzuela-Narváez, PhD DDS
role: Principal Investigator
affiliation: CONCYTEC
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PMID: 15899018
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PMID: 16681490
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responsible party type: Principal Investigator
investigator affiliation: Gastrovital
investigator full name: Valenzuela-Narváez Rocío Violeta
investigator title: PhD DDS
sharing ipd: No
provided document: 
provided document: 
provided document: 