Health TrialsbyHealthPanel

Development of a Sanitizing Tablet for Removable Partial Dentures

ConditionDenture Stomatitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Sao Paulo

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Crossover

Treatments tested in this trial

  • 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.

  • 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.

  • Phosphate-Buffered Saline (PBS)

    Other intervention

    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.

Treatment groups

15 Participants
are divided into 3 treatment groups
Group A: Experimental Tablet (NAC/Melaleuca)Experimental treatment 1 intervention
Group B: Active Control (NitrAdine)Active comparator 1 intervention
Group C: Placebo Control (PBS)Placebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Secondary outcomes

1

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
2

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
3

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Sao Paulo

Lead sponsor

Source ClinicalTrials.gov

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