Denture Stomatitis
Conditions
Brief summary
The goal of this clinical trial is to learn if a new experimental effervescent tablet works to clean removable partial dentures. It will test if the tablet lowers bacteria and fungi on denture surfaces. The main questions it aims to answer are: Does the experimental tablet lower the number of microbes on different denture materials? How happy are participants with the taste, odor, and cleanliness of the tablet? Researchers will compare the experimental tablet to a known commercial cleanser and to a neutral water solution to see which one works best. Total participation will last 70 days. First, researchers will place small material discs on the side of the participant's current denture to collect natural plaque. Participants will wear their dentures 24 hours a day and brush them with soap and water after meals. Participants will then cycle through three separate 14-day testing phases. In each phase, participants will soak their dentures daily for 15 minutes in one of the assigned solutions. Participants will also have a 7-day break between each phase where they return to their basic regular cleaning routine. At the end of each testing phase, researchers will remove the small discs to count the microbes in a laboratory. Participants will also answer a short survey about their satisfaction with each product.
Interventions
DEVICEExperimental Effervescent Tablet (NAC/Melaleuca)
An experimental effervescent tablet formulated with N-acetylcysteine (NAC) and Melaleuca alternifolia (Tea Tree) essential oil, designed for the daily chemical cleaning of removable partial dentures via a 15-minute immersion.
DEVICECommercial Cleansing Tablet (NitrAdine)
A commercially available disinfecting tablet used as a positive control for the chemical cleaning of removable partial dentures via a daily 15-minute immersion.
A neutral saline solution used as a negative control/placebo for the daily 15-minute denture immersion, serving to establish a baseline for mechanical cleaning alone.
Sponsors
University of Sao Paulo
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Participants aged 18 years or older. * Users of maxillary and/or mandibular removable partial dentures (RPD) made of acrylic resin. * Good systemic and oral health status, with enough healthy remaining teeth to support the RPD. * Agreement to follow the requested oral hygiene and denture cleaning protocols. * Ability to understand and sign the Informed Consent Form.
Exclusion criteria
* Use of systemic antibiotics, antifungals, or anti-inflammatory drugs within the last 3 months. * History of allergic reactions to N-acetylcysteine (NAC), Melaleuca alternifolia (tea tree) oil, or components of the commercial positive control (NitrAdine). * Severe periodontal disease or extensive untreated caries in the remaining teeth. * Severe systemic diseases, immunodeficiency, or conditions that compromise manual dexterity to perform denture brushing. * Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Microbial Load (Colony Forming Units) | Baseline (Day 14), Day 28, Day 49, and Day 70 | The microbial load of Candida spp., Streptococcus mutans, Staphylococcus spp., Gram-negative species, and total aerobes collected from the biofilm on the denture specimens will be evaluated using CFU counts per milliliter (CFU/mL). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Biofilm Cell Viability via Flow Cytometry | Baseline (Day 14), Day 28, Day 49, and Day 70 | The percentage of live, damaged, and dead microbial cells within the denture biofilm will be quantified using flow cytometry with viability staining (e.g., SYTO 9 and propidium iodide) to evaluate the antimicrobial efficacy of the cleaning methods. |
| Biofilm Gene Expression | Baseline (Day 14), Day 28, Day 49, and Day 70 | The relative expression levels of specific virulence and biofilm-associated genes of target microorganisms (e.g., Candida albicans) will be quantified using Real-Time Quantitative Reverse Transcription PCR (RT-qPCR) to understand the molecular impact of the interventions. |
| Participant Satisfaction and Perception of Cleanliness | Day 28, Day 49, and Day 70 | Participant perception regarding denture cleanliness, comfort, taste, and overall satisfaction with each cleaning protocol will be assessed using a structured Likert scale questionnaire. Total scores range from 1 to 5, where 1 indicates "Highly Unsatisfied" (worst possible outcome) and 5 indicates "Highly Satisfied" (best possible outcome). Higher scores represent a better outcome (higher satisfaction and better perception of cleanliness). |
Countries
Brazil
Contacts
CONTACTCarolina Alves Freiria de Oliveira, PhD student
Outcome results
None listed