An interventional study of Experimental Effervescent Tablet (NAC/Melaleuca) and Commercial Cleansing Tablet (NitrAdine) in Denture Stomatitis, sponsored by University of Sao Paulo. Not yet recruiting at 1 site in Brazil. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-06-01.
Sponsored by University of Sao Paulo · Not applicable, Interventional, and Supportive care
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.
23 studies on the registry are indexed under Stomatitis, Denture; 1 is open to participants now.
This study's planned enrollment of 15 is below the median of 30 across 19 interventional studies indexed under Stomatitis, Denture.
Browse Stomatitis, Denture studies →University of Sao Paulo is the lead sponsor of 1,005 studies on the registry; 90 are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will brush their dentures daily for 2 minutes using water and neutral soap after main meals. Once a day, they will also soak their dentures for 15 minutes in an effervescent solution formulated with N-acetylcysteine (NAC) and Melaleuca oil.
Device: Experimental Effervescent Tablet (NAC/Melaleuca)
Participants will brush their dentures daily for 2 minutes using water and neutral soap after main meals. Once a day, they will also soak their dentures for 15 minutes in a solution using the commercial cleansing tablet NitrAdine.
Device: Commercial Cleansing Tablet (NitrAdine)
Participants will brush their dentures daily for 2 minutes using water and neutral soap after main meals. Once a day, they will also soak their dentures for 15 minutes in a neutral Phosphate-Buffered Saline (PBS) solution.
Other: Phosphate-Buffered Saline (PBS)
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.
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.
Microbial Load (Colony Forming Units)
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).
Time frame: Baseline (Day 14), Day 28, Day 49, and Day 70
Biofilm Cell Viability via Flow Cytometry
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.
Time frame: Baseline (Day 14), Day 28, Day 49, and Day 70
Biofilm Gene Expression
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.
Time frame: Baseline (Day 14), Day 28, Day 49, and Day 70
Participant Satisfaction and Perception of Cleanliness
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).
Time frame: Day 28, Day 49, and Day 70
Plan to share: No — To do not interrupt the patent process
This study is not yet recruiting, as verified in May 2026. You cannot join it, but the record below documents what was studied.
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University of Sao Paulo