search
Back to results

A Castor Bean Solution for Cleaning Dentures (ACBSFCD)

Primary Purpose

Prostheses-related Infections

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physiological solution
Sodium hypochlorite
Alkaline Peroxide
Castor bean solution
Sponsored by
University of Sao Paulo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Prostheses-related Infections focused on measuring biofilm, castor bean, sodium hypochlorite, alkaline peroxide

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Adult patients of both genders, age-range 45 years and over, completely edentulous, in a good state of general health, wearers of maxillary complete dentures fabricated of heat polymerized acrylic resin and acrylic artificial teeth.

Exclusion Criteria:

  • Dentures that had been used for less than 03 years, and broken, fractured or relined dentures.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Placebo Comparator

    Active Comparator

    Active Comparator

    Experimental

    Arm Label

    Physiological solution

    Sodium hypochlorite

    Peroxide alkaline

    Castor bean solution

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Denture area covered with biofilm
    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 .

    Secondary Outcome Measures

    Full Information

    First Posted
    September 26, 2012
    Last Updated
    November 19, 2012
    Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT01732744
    Brief Title
    A Castor Bean Solution for Cleaning Dentures
    Acronym
    ACBSFCD
    Official Title
    A Castor Bean Solution Reduces Complete Denture Biofilm
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2012
    Overall Recruitment Status
    Completed
    Study Start Date
    March 2008 (undefined)
    Primary Completion Date
    November 2010 (Actual)
    Study Completion Date
    May 2011 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    University of Sao Paulo
    Collaborators
    Fundação de Amparo à Pesquisa do Estado de São Paulo

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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 .
    Detailed Description
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Prostheses-related Infections
    Keywords
    biofilm, castor bean, sodium hypochlorite, alkaline peroxide

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    ParticipantInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Physiological solution
    Arm Type
    Placebo Comparator
    Arm 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 Title
    Sodium hypochlorite
    Arm Type
    Active Comparator
    Arm 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 Title
    Peroxide alkaline
    Arm Type
    Active Comparator
    Arm 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 Title
    Castor bean solution
    Arm Type
    Experimental
    Arm 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(s)
    Physiological solution
    Other Intervention Name(s)
    Saline solution
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Sodium hypochlorite
    Other Intervention Name(s)
    1% Sodium hypochlorite
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Alkaline Peroxide
    Other Intervention Name(s)
    Effervescent tabs, Polident
    Intervention 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.
    Intervention Type
    Other
    Intervention Name(s)
    Castor bean solution
    Other Intervention Name(s)
    Ricinus communis solution, Castor oil solution
    Intervention 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.
    Primary Outcome Measure Information:
    Title
    Denture area covered with biofilm
    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 .
    Time Frame
    8 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    45 Years
    Maximum Age & Unit of Time
    80 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: Adult patients of both genders, age-range 45 years and over, completely edentulous, in a good state of general health, wearers of maxillary complete dentures fabricated of heat polymerized acrylic resin and acrylic artificial teeth. Exclusion Criteria: Dentures that had been used for less than 03 years, and broken, fractured or relined dentures.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Ingrid M Andrade, PhD
    Organizational Affiliation
    University of São Paulo
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Learn more about this trial

    A Castor Bean Solution for Cleaning Dentures

    We'll reach out to this number within 24 hrs