Clinical evaluation of the addition of antifungal drugs to denture liner material in the treatment of oral candidiasis

INTERVENTION: D02.540.505.575 D02.078.370.141.100 The sample of this study involved patients using conventional upper complete denture with denture stomatitis on the palatal denture‐bearing mucosa, attended in the Prosthodontics Clinic of the Bauru School of Dentistry of the University of São Paulo. It was selected 40 patients in these conditions, regardless of age, gender, mandibular arch situation and lower prosthesis in use. The 40 patients were randomly divided into 4 study groups with 10 individuals each, two active controls and two experimental groups, according to the type of treatment instituted. The group Antifungal Control consisted of 10 patients who used conventional topical antifungal medication based on nystatin in oral suspension (100,000 Ul), according to the posology of the package insert, that is, after cleaning and removing the upper complete denture, a mouth rinse was performed for 1 minute of 1 dropper full of medication before its disposal, 4 times a day, for 14 days. The group Reline Control was represented by 10 patients who had their upper complete dentures relined with a drug‐free temporary resilient material for 14 days. In the group Experimental Chlorhexidine, upper complete dentures of the 10 patients were relined with a temporary resilient material modified by the addition of 98% chlorhexidine diacetate at minimum inhibitory concentration for Candida albicans biofilm (0.064 gram of drug for each gram of reline material powder) for 14 days. In the group Experimental Nystatin, upper complete dentures of the 10 patients were relined with a temporary resilient material modified by the addition of nystatin at minimum inhibitory concentration for Candida albicans biofilm (0.032 gram of drug for each gram of reline material powder) for 14 days. At the end of the treatment period (14 days), patien CONDITION: C01 Infecções Candida; Upper Complete Denture; Denture Stomatitis PRIMARY OUTCOME: Primary outcome 1: Reduction of mycelial forms of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by cytological examinations by smears obtained from these areas, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of treatment discontinuation), of at least a 30% improvement in palatal smears as well as a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment on the prosthetic smears. Primary outcome 2: Reduction in the values of colony forming units per milliliter of Candida species both on the palatal mucosa affected by denture stomatitis and on the inner surface of the upper complete denture, verified by means of quantitative mycological cultures, from the observation, at the end of the treatment (14 days) and at the end of the experimental period (60 days of suspension of the treatment) of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of treatment in cultures of both palate and prosthesis areas. Primary outcome 3: Reduction of clinical severity of denture stomatitis, verified by means of standardized photographs of the palatal mucosa affected by the lesion, from the observation, at the end of treatment (14 days) and at the end of the experimental period (60 days after suspension of treatment), of a large (greater or equal to 0.8) or very large (greater or equal to 1.20) effect size of the treatment. SECONDARY OUTCOME: Secondary outcome 1: Assess whether the main general and local factors associated with Candida proliferation (patient's age and sex, age and nighttime use of current dentures, smoking, the type of denture stomatitis according to Newton, the use of xerostomia‐inducing drugs, presence of xerostomia and poor oral and prosthesis hygiene habits) were present in most volunteers, through anamnesis, clinical examination and examination of the prosthesis, to verify their influence as predisposing factors to denture stomatitis. INCLUSION CRITERIA: Volunteer users of conventional removable upper denture; clinical diagnosis for denture stomatitis in the palatal mucosa supporting the complete denture, both genders, any age, regardless of the condition of the mandibular arch and the use and status of the lower denture.