School of Dentistry of Ribeirão Preto
Ribeirão Preto, São Paulo, 14051260, Brazil
NCT Number: NCT07608211
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.
Trial opening soon.
Get Notified18 year and older
All sexes
Interventional
Not applicable
Ribeirão Preto, São Paulo, 14051260, Brazil
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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).
Contact information is provided by the study sponsor or research team.
University of Sao Paulo
Other
Development of a Denture Cleanser Tablet: Evaluation of Antibiofilm Activity and Effects on the Constituent Surfaces of Removable Partial Dentures.
Acronym: DSRPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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