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Effectiveness of Hygiene Solutions on Denture Biofilm

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ClinicalTrials.gov Identifier: NCT02407834
Recruitment Status : Completed
First Posted : April 3, 2015
Last Update Posted : April 3, 2015
Sponsor:
Collaborators:
Fundação de Amparo à Pesquisa do Estado de São Paulo
Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
Information provided by (Responsible Party):
Cláudia Helena Lovato da Silva, University of Sao Paulo

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).

Condition or disease Intervention/treatment Phase
Stomatitis Other: S1 Other: S2 Other: S3 Other: S4 Phase 4

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 64 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Supportive Care
Official Title: Clinical Evaluation of an Experimental Solution Based on Ricinus Communis Compared to Sodium Hypochlorite for Denture Cleansing
Study Start Date : August 2012
Actual Primary Completion Date : June 2013
Actual Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dentures

Arm Intervention/treatment
Experimental: S1 - 0.25% sodium hypochlorite
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
Immersion in 0.25% sodium hypochlorite for 20 minutes, during 7 days.
Other Name: 0.25% sodium hypochlorite

Experimental: S2 - 0.5% sodium hypochlorite
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
Immersion in 0.5% sodium hypochlorite for 20 minutes, during 7 days.
Other Name: 0.5% sodium hypochlorite

Experimental: S3 - 10% Ricinus communis
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
Immersion in 10% Ricinus communis for 20 minutes, during 7 days.
Other Name: 10% ricinus communis

Placebo Comparator: S4 - saline solution
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 Saline solution for 20 minutes, during 7 days.
Other Name: saline solution




Primary Outcome Measures :
  1. biofilm removal capacity using Image Tool software [ Time Frame: 7 days ]
  2. antimicrobial action against specific microorganisms by Colony Forming Units counts [ Time Frame: 7 days ]

Secondary Outcome Measures :
  1. remission of atrophic chronic candidiasis using multinomial logistic regression analysis [ Time Frame: 7 days ]
  2. degree of patient satisfaction assessed by specific questionnaire [ Time Frame: 7 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Edentulous that make regular use of dentures in acrylic resin for at least one year with the presence of biofilm.

Exclusion Criteria:

  • Problems in adapting, reline, or repair fractures
  • Patients with limited communication or collaboration as the following recommended protocol.
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Responsible Party: Cláudia Helena Lovato da Silva, University of Sao Paulo
ClinicalTrials.gov Identifier: NCT02407834    
Other Study ID Numbers: mestradopt2013
First Posted: April 3, 2015    Key Record Dates
Last Update Posted: April 3, 2015
Last Verified: March 2015
Keywords provided by Cláudia Helena Lovato da Silva, University of Sao Paulo:
Biofilms
Dentures
Denture Cleansers
Castor Oil
Stomatitis
Additional relevant MeSH terms:
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Stomatitis
Mouth Diseases
Stomatognathic Diseases
Sodium Hypochlorite
Eusol
Disinfectants
Anti-Infective Agents