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NCT Number: NCT07608211

Development of a Sanitizing Tablet for Removable Partial Dentures

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

School of Dentistry of Ribeirão Preto

Ribeirão Preto, São Paulo, 14051260, Brazil

Location contact

Carolina Alves Freiria de Oliveira, PhD student

CONTACT

[email protected]

+5535992436266

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

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.

Primary outcomes

  1. Microbial Load (Colony Forming Units)

    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).

Secondary outcomes

  1. Biofilm Cell Viability via Flow Cytometry

    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.

  2. Biofilm Gene Expression

    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.

  3. Participant Satisfaction and Perception of Cleanliness

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Carolina Alves Freiria de Oliveira, PhD student

CONTACT

[email protected]

+5535992436266

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

Development of a Denture Cleanser Tablet: Evaluation of Antibiofilm Activity and Effects on the Constituent Surfaces of Removable Partial Dentures.

Acronym: DSRPD

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
May 27, 2026
Registry last updated
Jun 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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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