<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/NCT01732744</url>
  </required_header>
  <id_info>
    <org_study_id>FORP_491</org_study_id>
    <nct_id>NCT01732744</nct_id>
  </id_info>
  <brief_title>A Castor Bean Solution for Cleaning Dentures</brief_title>
  <acronym>ACBSFCD</acronym>
  <official_title>A Castor Bean Solution Reduces Complete Denture Biofilm</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Sao Paulo</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Fundação de Amparo à Pesquisa do Estado de São Paulo</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Sao Paulo</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of&#xD;
      complete denture biofilm, comparing it with two products available on the market (sodium&#xD;
      hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed&#xD;
      to brush their dentures after meals and once a day, for a period of 07 days, immerse them in&#xD;
      the following solutions: A - Control: Physiological solution(20 minutes). B - Polident&#xD;
      alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based&#xD;
      solution(20 minutes). The participants immersed their dentures in each of the solutions,&#xD;
      according to a randomized sequence. For biofilm quantification, before (Baseline) and after&#xD;
      the use of each product, the internal surfaces of maxillary complete dentures were revealed&#xD;
      (1% neutral red), photographed and the stained biofilm was quantified with the aid of&#xD;
      software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm),&#xD;
      the percentage of surface covered by biofilm of the complete denture was calculated .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study sought to minimize the occurrence of bias, and whenever possible sought to &quot;blind&quot;&#xD;
      the parties involved (researchers, volunteers and statisticians), since none of them had&#xD;
      knowledge of the allocation of treatments. The present study also followed the criteria&#xD;
      described in the CONSORT Declaration&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2008</start_date>
  <completion_date type="Actual">May 2011</completion_date>
  <primary_completion_date type="Actual">November 2010</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>Crossover Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Denture area covered with biofilm</measure>
    <time_frame>8 weeks</time_frame>
    <description>The volunteers were instructed to brush their dentures ,3 times a day and use the following chemical immersion methods, only once a day after dinner: A)Physiological solution .B) 1% Sodium Hypochlorite .C) Polident Alkaline Peroxide .D) 2,0% Castor bean solution . All the volunteers used one of the four chemical methods in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure.On the first day and after 07 days of using the interventions, the internal surfaces of dentures were revealed with 1% neutral red solution and photographed with a digital photographic camera. Biofilm was measured on the photographic images of the complete dentures, using the computerized quantitative method &quot;ImageTool&quot;. After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Prostheses-related Infections</condition>
  <arm_group>
    <arm_group_label>Physiological solution</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>1)Negative Control: physiological solution, for 20 minutes&#xD;
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sodium hypochlorite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2)active Comparator 1: Sodium hypochlorite, for 20 minutes&#xD;
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Peroxide alkaline</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>2)Active Comparator 2: Alkaline peroxide (Polident), for 5 minutes&#xD;
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Castor bean solution</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>3)Experimental: castor bean solution, for 20 minutes&#xD;
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Physiological solution</intervention_name>
    <description>The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.</description>
    <arm_group_label>Physiological solution</arm_group_label>
    <other_name>Saline solution</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sodium hypochlorite</intervention_name>
    <description>The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.</description>
    <arm_group_label>Sodium hypochlorite</arm_group_label>
    <other_name>1% Sodium hypochlorite</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Alkaline Peroxide</intervention_name>
    <description>The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.</description>
    <arm_group_label>Peroxide alkaline</arm_group_label>
    <other_name>Effervescent tabs</other_name>
    <other_name>Polident</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Castor bean solution</intervention_name>
    <description>The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.</description>
    <arm_group_label>Castor bean solution</arm_group_label>
    <other_name>Ricinus communis solution</other_name>
    <other_name>Castor oil solution</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients of both genders, age-range 45 years and over, completely edentulous, in&#xD;
             a good state of general health, wearers of maxillary complete dentures fabricated of&#xD;
             heat polymerized acrylic resin and acrylic artificial teeth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Dentures that had been used for less than 03 years, and broken, fractured or relined&#xD;
             dentures.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>45 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ingrid M Andrade, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of São Paulo</affiliation>
  </overall_official>
  <verification_date>November 2012</verification_date>
  <study_first_submitted>September 26, 2012</study_first_submitted>
  <study_first_submitted_qc>November 19, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 26, 2012</study_first_posted>
  <last_update_submitted>November 19, 2012</last_update_submitted>
  <last_update_submitted_qc>November 19, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Ingrid Machado de Andrade</investigator_full_name>
    <investigator_title>Phd</investigator_title>
  </responsible_party>
  <keyword>biofilm, castor bean, sodium hypochlorite, alkaline peroxide</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Prosthesis-Related Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sodium Hypochlorite</mesh_term>
    <mesh_term>Eusol</mesh_term>
    <mesh_term>Castor Oil</mesh_term>
    <mesh_term>Pharmaceutical Solutions</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01732744
org study id: FORP_491
nct id: NCT01732744
lead sponsor: 
collaborator: 
has dmc: No
To evaluate the efficacy of a castor bean-based solution (Ricinus communis) for removal of
      complete denture biofilm, comparing it with two products available on the market (sodium
      hypochlorite and alkaline peroxide). Fifty complete maxillary denture-wearers were instructed
      to brush their dentures after meals and once a day, for a period of 07 days, immerse them in
      the following solutions: A - Control: Physiological solution(20 minutes). B - Polident
      alkaline peroxide(3 minutes). C - 1% sodium hypochlorite(20 minutes). D - castor bean-based
      solution(20 minutes). The participants immersed their dentures in each of the solutions,
      according to a randomized sequence. For biofilm quantification, before (Baseline) and after
      the use of each product, the internal surfaces of maxillary complete dentures were revealed
      (1% neutral red), photographed and the stained biofilm was quantified with the aid of
      software (Image Tool 3.0). After concluding measurements of the areas (total and biofilm),
      the percentage of surface covered by biofilm of the complete denture was calculated .
The study sought to minimize the occurrence of bias, and whenever possible sought to "blind"
      the parties involved (researchers, volunteers and statisticians), since none of them had
      knowledge of the allocation of treatments. The present study also followed the criteria
      described in the CONSORT Declaration
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Denture area covered with biofilm
time frame: 8 weeks
description: The volunteers were instructed to brush their dentures ,3 times a day and use the following chemical immersion methods, only once a day after dinner: A)Physiological solution .B) 1% Sodium Hypochlorite .C) Polident Alkaline Peroxide .D) 2,0% Castor bean solution . All the volunteers used one of the four chemical methods in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure.On the first day and after 07 days of using the interventions, the internal surfaces of dentures were revealed with 1% neutral red solution and photographed with a digital photographic camera. Biofilm was measured on the photographic images of the complete dentures, using the computerized quantitative method "ImageTool". After concluding measurements of the areas (total and biofilm), the percentage of surface covered by biofilm of the complete denture was calculated .
arm group label: Physiological solution
arm group type: Placebo Comparator
description: 1)Negative Control: physiological solution, for 20 minutes
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.
arm group label: Sodium hypochlorite
arm group type: Active Comparator
description: 2)active Comparator 1: Sodium hypochlorite, for 20 minutes
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.
arm group label: Peroxide alkaline
arm group type: Active Comparator
description: 2)Active Comparator 2: Alkaline peroxide (Polident), for 5 minutes
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.
arm group label: Castor bean solution
arm group type: Experimental
description: 3)Experimental: castor bean solution, for 20 minutes
All the volunteers used one of the four chemical methods (interventions) in a random sequence for a period of 07 days each. Between each period of use, there was a one week wash out period during which the patient performed his/her habitual cleaning procedure, in order to avoid a carry-over effect.
intervention type: Other
intervention name: Physiological solution
description: The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
arm group label: Physiological solution
other name: Saline solution
intervention type: Other
intervention name: Sodium hypochlorite
description: The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
arm group label: Sodium hypochlorite
other name: 1% Sodium hypochlorite
intervention type: Other
intervention name: Alkaline Peroxide
description: The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
arm group label: Peroxide alkaline
other name: Effervescent tabs
other name: Polident
intervention type: Other
intervention name: Castor bean solution
description: The volunteers were instructed to brush the internal surface of complete dentures for 2 minutes, 3 times a day, after meals (breakfast, lunch and dinner) and use the following chemical immersion methods, only once a day after dinner: A - Control (Co): Physiological solution, for 20 minutes. B) 1% Sodium Hypochlorite, for 20 minutes. C) Polident Alkaline Peroxide, for 3 minutes. D) 2,0% Castor bean solution Ricinus communis, for 20 minutes. In addition, the participants were instructed to immerse their dentures in water during the night period, before going to sleep.
arm group label: Castor bean solution
other name: Ricinus communis solution
other name: Castor oil solution
criteria: 
gender: All
minimum age: 45 Years
maximum age: 80 Years
healthy volunteers: No
last name: Ingrid M Andrade, PhD
role: Principal Investigator
affiliation: University of São Paulo
responsible party type: Principal Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Ingrid Machado de Andrade
investigator title: Phd
mesh term: Prosthesis-Related Infections
mesh term: Sodium Hypochlorite
mesh term: Eusol
mesh term: Castor Oil
mesh term: Pharmaceutical Solutions