Effectiveness of Hygiene Solutions on Denture Biofilm
Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing
1 other identifier
interventional
64
0 countries
N/A
Brief Summary
This clinical trial evaluated Ricinus communis and sodium hypochlorite solutions in different concentrations for denture cleanliness, regarding biofilm removal capacity, remission of atrophic chronic candidiasis, degree of patient satisfaction and antimicrobial action against specific microorganism. Sixty-four denture wearers with absence (n=40) or presence of Candidiasis (n=24) were selected and oriented to brush their dentures with a specific brush and neutral soap for 3 minutes, 3 times a day and immerse them, once a day, in hygiene solutions (0.25% sodium hypochlorite - S1 and 0.5% - S2, 10% R. communis - S3; Saline - S4: control) during 20 minutes, for 7 days. The solutions were used in a randomized, double blind and cross form with washout periods. To quantify biofilm with software ImageTool 3.0, the inner surface was disclosed (1% neutral red) and photographed at the end of each period. The Candidiasis remission was assessed by scores before and after the use of solutions. Patient satisfaction was assessed by questionnaire. Antimicrobial activity was determined by Colony Forming Units (CFU) counts of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, internal surface of each maxillary complete denture was brushed with saline solution, and the biofilm suspension obtained. After serial dilutions (100 - 10-3), 50 uL aliquots were seeded in Petri dishes containing Mitis salivarius agar base, CHROMagar Candida® and MacConkey agar for detecting S. mutans, Candida spp., or gram-negative microorganisms, respectively. After incubation, colonies were counted, and values in CFU/mL were calculated. Biofilm removal was analyzed as a split-plot with two variation factors: inflammation and solutions. The candidiasis remission was analyzed after adjustment using multinomial logistic regression. Logistic regression analysis and compound symmetry was adopted for patient satisfaction. The antimicrobial action was analyzed with Friedman´s test. Antimicrobial action data were processed after transformation - log10 (CFU + 1) - and were analyzed by Friedman test (α = 0.05).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Aug 2012
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2013
CompletedFirst Submitted
Initial submission to the registry
February 9, 2015
CompletedFirst Posted
Study publicly available on registry
April 3, 2015
CompletedApril 3, 2015
March 1, 2015
10 months
February 9, 2015
April 2, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
biofilm removal capacity using Image Tool software
7 days
antimicrobial action against specific microorganisms by Colony Forming Units counts
7 days
Secondary Outcomes (2)
remission of atrophic chronic candidiasis using multinomial logistic regression analysis
7 days
degree of patient satisfaction assessed by specific questionnaire
7 days
Study Arms (4)
S1 - 0.25% sodium hypochlorite
EXPERIMENTALBrushing with specific brush and neutral soap, three times a day. After, immesion in 0.25% sodium hypochlorite during 20 minutes, once a day. This protocol was used during 7 days.
S2 - 0.5% sodium hypochlorite
EXPERIMENTALBrushing with specific brush and neutral soap, three times a day. After, immesion in 0.5% sodium hypochlorite during 20 minutes, once a day.This protocol was used during 7 days.
S3 - 10% Ricinus communis
EXPERIMENTALBrushing with specific brush and neutral soap, three times a day. After, immesion in 10% Ricinus communis solution during 20 minutes, once a day. This protocol was used during 7 days.
S4 - saline solution
PLACEBO COMPARATORBrushing with specific brush and neutral soap, three times a day. After, immesion in saline solution during 20 minutes, once a day. This protocol was used during 7 days.
Interventions
Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
Immersion in Saline solution for 20 minutes, during 7 days.
Eligibility Criteria
You may qualify if:
- Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.
You may not qualify if:
- Problems in adapting, reline, or repair fractures
- Patients with limited communication or collaboration as the following recommended protocol.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Cláudia Helena Lovato da Silva
Study Record Dates
First Submitted
February 9, 2015
First Posted
April 3, 2015
Study Start
August 1, 2012
Primary Completion
June 1, 2013
Study Completion
December 1, 2013
Last Updated
April 3, 2015
Record last verified: 2015-03