Effectiveness of Hygiene Solutions on Denture Biofilm
Condition: Stomatitis
MeSH terms: Stomatitis
Study type: Interventional
Phase: Phase 4

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).
    

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.
    

Intervention name(s): S1; S2; S3; S4
Intervention type(s): Other; Other; Other; Other
Intervention description(s): 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.
Other intervention name(s): 0.25% sodium hypochlorite; 0.5% sodium hypochlorite; 10% ricinus communis; saline solution
Intervention MeSH terms: Sodium Hypochlorite; Eusol
Allocation: Randomized
Intervention model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary purpose: Supportive Care
Keywords: Biofilms; Dentures; Denture Cleansers; Castor Oil; Stomatitis