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| ID | Type | Description | Link |
|---|---|---|---|
| 2024/06375-0 | Other Identifier | FAPESP |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental Tablet (NAC/Melaleuca) | Experimental | 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. |
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| Active Control (NitrAdine) | Active Comparator | 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. |
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| Placebo Control (PBS) | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental Effervescent Tablet (NAC/Melaleuca) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline (Day 14), Day 28, Day 49, and Day 70 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline (Day 14), Day 28, Day 49, and Day 70 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Carolina Alves Freiria de Oliveira, PhD student | Contact | +5535992436266 | carolina.alves.oliveira@usp.br |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| School of Dentistry of Ribeirão Preto | Ribeirão Preto | São Paulo | 14051260 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39331828 | Background | Moraes LGDS, Oliveira VC, Macedo AP, Freiria de Oliveira CA, Watanabe E, Pagnano VO. Enhancing Removable Partial Denture Hygiene: Investigating Mucolytic Agents and Biocides for Disrupting Biofilms and Improving Antimicrobial Efficacy. Int J Prosthodont. 2025 Sep 25;38(5):559-569. doi: 10.11607/ijp.9133. | |
| 41227976 | Background |
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To do not interrupt the patent process
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| ID | Term |
|---|---|
| D013282 | Stomatitis, Denture |
| ID | Term |
|---|---|
| D013280 | Stomatitis |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| Commercial Cleansing Tablet (NitrAdine) | Device | A commercially available disinfecting tablet used as a positive control for the chemical cleaning of removable partial dentures via a daily 15-minute immersion. |
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| Phosphate-Buffered Saline (PBS) | Other | 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. |
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| 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. |
| 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). | Day 28, Day 49, and Day 70 |
| Correa PGL, Cruz-Araujo SR, Freiria de Oliveira CA, Silva RRD, Oliveira VC, Pagnano VO, Silva-Lovato CH, Galo R, Stirke A, Melo WCMA, Macedo AP. Evaluation of Colonization by Candida albicans and Biofilm Formation on 3D-Printed Denture Base Resins. Materials (Basel). 2025 Nov 4;18(21):5018. doi: 10.3390/ma18215018. |
| 40957068 | Background | Freiria de Oliveira CA, Macedo AP, Oliveira VC, de Moraes LGS, Tonin BSH, Galo R, Pagnano VO. Impact of Peracetic Acid and Cetylpyridinium Chloride Disinfection on Removable Partial Denture Materials. Int J Prosthodont. 2025 Sep 16;0(0):1-21. doi: 10.11607/ijp.9470. Online ahead of print. |
| 38047547 | Result | Freiria de Oliveira CA, Moraes LGDS, Vilela Teixeira AB, Pagnano VO. Antimicrobial activity of cleansers on the cobalt-chromium surface of removable partial denture: a systematic review. Biofouling. 2023 Oct-Nov;39(9-10):916-927. doi: 10.1080/08927014.2023.2290120. Epub 2023 Dec 4. |