Effect of local hygiene protocols on denture-related stomatitis, biofilm, microbial load, and odor: A randomized controlled trial.

STATEMENT OF PROBLEM: Denture stomatitis affects complete denture wearers and is frequently treated with antifungals drugs, as well as treating the denture with sodium hypochlorite. Whether the limitations of these treatments can be overcome with local hygiene protocols that do not damage the denture materials or adversely affect the patient is unclear. PURPOSE: The purpose of this randomized controlled trial was to evaluate the effect of denture hygiene protocols on complete denture wearers with denture stomatitis. MATERIAL AND METHODS: For this randomized, double-blind controlled clinical trial, 108 participants were assigned to parallel groups: 0.25% sodium hypochlorite (positive control) 0.15% Triclosan, denture cleaning tablets, or denture cleaning tablets plus gingival cleaning tablets. The participants were instructed to brush the dentures and the palate and immerse the denture in the solutions. The outcomes of denture stomatitis remission, biofilm removal, decrease of microbial load (colony-forming units), and odor level of the mouth and denture were measured at baseline and after 10 days. Descriptive analyses were used for sociodemographic characterization of the participants; the Pearson chi-square test was used to compare participant frequency with different degrees of denture stomatitis. The data were not normally distributed (Shapiro-Wilks test) or homogeneous (Levene test). So, the Kruskal-Wallis and Dunn post hoc tests and Wilcoxon test were used to compare the effects of solutions and time on the variables (α=.05). RESULTS: The frequency of the highest to lowest denture stomatitis scores was significantly different for the 0.15% Triclosan and denture cleaning tablets groups. No significant difference was found among the groups in terms of denture stomatitis scores, biofilm, or colony-forming unit count of Candida spp. or C. albicans and S. mutans; a significant reduction was found in these parameters. The 0.25% sodium hypochlorite and 0.15% Triclosan treatments caused a significant reduction in Gram-negative microorganisms; these 2 protocols, and the denture cleaning tablets showed a significant reduction in Staphylococcus spp.; all protocols had similar effects. Only the S. mutans count of the palate decreased after 10 days. The odor level of the mouth and the denture was not significantly different (P=.778). CONCLUSIONS: The evaluated protocols can be recommended for the hygiene of complete dentures, since they were effective for all the variables studied.

Effect of Denture Hygiene Protocols on Patient Satisfaction, Oral Health-Related Quality of Life, and Salivary Parameters: A Randomized Clinical Trial.

PURPOSE: This randomized controlled trial compared four denture hygiene protocols in terms of patient satisfaction, oral health-related quality of life (OHRQoL), and salivary parameters in complete denture wearers with denture stomatitis. MATERIAL AND METHODS: For this randomized, double-blind, controlled clinical trial, 108 participants were assigned to soak their dentures in one of the following solutions: (1) 0.25% sodium hypochlorite (positive control), (2) 0.15% Triclosan, (3) denture disinfecting tablets, or (4) denture disinfecting tablets plus palatine mucosa brushing solution. The outcomes of patient satisfaction, OHRQoL, and salivary parameters (salivary flow rate and pH) were measured at baseline and after 10 days. The Kruskal-Wallis and Dunn tests (between groups), and Wilcoxon test (between times) were used to compare the results. (α = 0.05). RESULTS: After the hygiene protocols, and when compared with baseline, the overall patient satisfaction, maxillary denture satisfaction, maxillary denture comfort, and maxillary denture retention were ameliorated. A significant improvement was noted in OHRQoL in 3 of 4 domains evaluated (orofacial pain and discomfort, masticatory discomfort and disability, and psychological disability and discomfort). The salivary flow rate (unstimulated and stimulated) and salivary pH were not significantly affected at the times evaluated. CONCLUSIONS: Complete denture wearers may feel more satisfied with their complete dentures when treated for denture stomatitis. The tested treatments lead to similar improvement in terms of patient satisfaction and OHRQoL.

The safety and efficacy of AphtoFix® mouth ulcer cream in the management of recurrent aphthous stomatitis.

BACKGROUND: Recurrent Aphthous stomatitis (RAS) is a prevalent ulcerative and painful disorder of the oral cavity with unknown etiology and for which no efficient treatment is currently available. The present study aimed to evaluate the safety and the efficacy of AphtoFix®, a new mouth ulcer cream that was developed to help treat RAS. Prior to launching the product on the market, two initial safety assessment studies were performed. SUBJECTS AND METHODS: In a first study, the in vitro biocompatibility of AphtoFix® was evaluated on reconstructed human gingival tissue models according to ISO guidelines 10993. In a second study, the tolerability of AphtoFix® was evaluated in 20 subjects during a 4-weeks daily application in the mouth. The third study investigated both the safety and efficacy of AphtoFix® treatment on 19 patients suffering from RAS. This study was done in compliance with the Helsinki Declaration. RESULTS: The results of in vitro biocompatibility study showed that AphtoFix® mouth ulcer cream did not induce any detectable cytotoxicity and irritation. These observations were confirmed in the 4 weeks tolerability study where no undesired of adverse reactions were noticed. The results of the post-market clinical efficacy study demonstrated a clear reduction in ulcer size from baseline after 3 days treatment (p < 0.05). Pain intensity reduction was also observed in all subjects. CONCLUSION: The application of AphtoFix® did not induce any undesired skin or mucosa reactions. These initial findings demonstrate that AphtoFix® is safe and efficient in reducing ulcer size and decreasing the pain intensity induced by ulcers. TRIAL REGISTRATION: Clinical trial Registry India Nr. CTRI201408004918 , Date of registration: 22/08/2014.

Efficacy of PerioTabs, a NitrAdine-based gingiva brushing solution, on periodontally affected patients treated with fixed partial dentures: a randomized controlled study.

Objectives: Recent data show that teeth prepared with horizontal finishing lines supporting crowns and fixed partial dentures present more periodontal disorders than untreated control teeth. Several studies have shown that NitrAdine (bonyf) induces a significant reduction of dental biofilm. The aim of this study was to demonstrate that 10-day use of PerioTabs (bonyf), a NitrAdine-based gingiva brushing solution, is effective in treating gingival inflammation of prosthodontic patients. Method and materials: Forty-nine subjects were instructed to brush their teeth, gingivae, and prostheses with the PerioTabs solution for 10 days (treatment group) and 49 with any toothpaste (control group). The initial and 11-day Plaque Index and Bleeding Index were recorded. A five-point Likert scale was used to evaluate the level of patient satisfaction. The Shapiro-Wilk statistical test was used to compare the results for the two groups. Results: Highly significant differences between the treatment and control group (P < .001) for the Plaque Index and Bleeding Index resulted. The treatment group patients' satisfaction was high: 31 (63.3%) reported the highest level, 5, on the Likert scale, and 18 (36.7%) declared they were satisfied (level 4). Conclusions: The use of a NitrAdine-based gingiva brushing solution (PerioTabs) was effective in reducing the gingival inflammation in periodontally affected patients treated with fixed partial dentures. Clinical relevance: The NitrAdine-based gingiva brushing solution (PerioTabs) was highly accepted by the patients and seems to be a promising alternative to the solutions widely used.

The effect of NitrAdine on the Candida levels of maxillary removable appliances.

OBJECTIVE: Candida colonization is a consequence of orthodontic treatment and can lead to oral candidosis as a complication of maxillary removable appliance treatment. During orthodontic treatment, it is important to minimize colonization to prevent active infection that could consequently interfere with treatment. Hygiene is the most important factor in managing colonization; in this study, the efficacy of NitrAdine to reduce Candida was tested. METHOD AND MATERIALS: A randomized, double-blind, placebo-controlled trial was performed. Ninety-two patients 11 to 14 years of age were recruited at the Children's and the University Dental Clinics at Mater Dei Hospital, Tal-Qroqq, Msida, Malta. Forty-four patients used the product with NitrAdine, while 48 patients used a placebo. Sampling employing the imprint technique was performed before and after the product was used. Brilliance Candida agar was used for cultures and identification. Further identification was performed using Auxacolor 2 when required. RESULTS: The control group had a statistically significant increase in Candida during treatment, while the experimental group had a nonstatistically significant decrease. CONCLUSION: It was concluded that NitrAdine may reduce the Candida burden in maxillary removable appliances. Larger sample sizes are needed to achieve statistical significance.

Randomized, double-blind, placebo-controlled trial to test the efficacy of nitradine tablets in maxillary removable orthodontic appliance patients.

OBJECTIVE: to evaluate the efficiency of NitrAdine (MSI Laboratories) tablets in the reduction of oral Candida levels, biofilm formation, and appliance odor in maxillary removable orthodontic appliance wearers. METHOD AND MATERIALS: seventy children between 11 and 15 years of age undergoing maxillary removable appliance treatment were assigned via a double-blind randomized method to the experimental or placebo arm of the study. One milliliter of unstimulated saliva was collected at the beginning of the experiment and 6 weeks later after treatment of the maxillary removable appliance with NitrAdine tablets. Samples were cultured on chromogenic Candida agar, and the number of colony-forming units per mL of saliva (CFU mL-1) was determined. RESULTS: there was no significant difference in salivary Candida levels before or after treatment with NitrAdine tablets. There was a significant drop in plaque accumulation on the appliance and a significant amelioration in appliance odor. There was a small, nonsignificant drop in individuals exhibiting counts of 400 CFU mL-1 or more in the experimental group and a nonsignificant increase in the number of new species in the placebo group. CONCLUSIONS: NitrAdine tablets are effective in reducing plaque accumulation and appliance odor during maxillary removable appliance treatment. Further in vivo studies are required to determine the efficacy and exact protocol for NitrAdine tablets in appliance disinfection.