A Phase 4 interventional study of S1 and S2 in Stomatitis, sponsored by University of Sao Paulo. Completed. Open to participants aged 45 Years to 80 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-04-03.
Sponsored by University of Sao Paulo · Phase 4, Interventional, and Supportive care
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).
Sixty-four denture wearers with (n=24) and without Candidiasis (n=40) were enrolled and instructed to brush and immerse their dentures in 4 different storage solutions (S1: 0.25% sodium hypochlorite; S2: 0.5% sodium hypochlorite; S3: 10% R. communis; and S4: Saline/Control). The interventions were randomly performed in a double blind and crossover format with washout periods. After 7 days of brushing and storage, the biofilm formed in the inner surfaces of dentures was disclosed and photographed to quantification. Candidiasis remission was assessed by scores and the patient satisfaction by a questionnaire. Antimicrobial activity of the solutions was determined by counting the Colony Forming Units (CFUs) of Streptococcus mutans, Candida spp., and gram-negative microorganisms. For collecting biofilm, each complete upper denture was placed in a Petri dish, its internal surface was brushed (Tek brush) with saline solution for 2 min, and the biofilm suspension was transferred to a test tube. 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.
400 studies on the registry are indexed under Stomatitis; 83 are open to participants now.
This study's enrollment of 64 is close to the median of 60 across 349 interventional studies indexed under Stomatitis.
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Exclusion Criteria:
Brushing 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.
Other: S1
Brushing 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.
Other: S2
Brushing 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.
Other: S3
Brushing 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.
Other: S4
Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
Also known as: 0.25% sodium hypochlorite
Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
Also known as: 0.5% sodium hypochlorite
Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
Also known as: 10% ricinus communis
Immersion in Saline solution for 20 minutes, during 7 days.
Also known as: saline solution
biofilm removal capacity using Image Tool software
Time frame: 7 days
antimicrobial action against specific microorganisms by Colony Forming Units counts
Time frame: 7 days
remission of atrophic chronic candidiasis using multinomial logistic regression analysis
Time frame: 7 days
degree of patient satisfaction assessed by specific questionnaire
Time frame: 7 days
No study locations are listed for this record.
This study is completed, as verified in Mar 2015. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo