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Development of a Sanitizing Tablet for Removable Partial Dentures (DSRPD)

27. maj 2026 opdateret af: Carolina Alves Freiria de Oliveira, University of Sao Paulo

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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

15

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Brasilien
    • São Paulo
      • Ribeirão Preto, São Paulo, Brasilien, 14051260
        • School of Dentistry of Ribeirão Preto
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ja

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Støttende pleje
  • Tildeling: Randomiseret
  • Interventionel model: Crossover opgave
  • Maskning: Dobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Experimental 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 an effervescent solution formulated with N-acetylcysteine (NAC) and Melaleuca oil.
Enhed: Experimental Effervescent Tablet (NAC/Melaleuca)
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.
Aktiv komparator: Active Control (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 solution using the commercial cleansing tablet NitrAdine.
Enhed: Commercial Cleansing Tablet (NitrAdine)
A commercially available disinfecting tablet used as a positive control for the chemical cleaning of removable partial dentures via a daily 15-minute immersion.
Placebo komparator: Placebo Control (PBS)
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.
Andet: Phosphate-Buffered Saline (PBS)
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Microbial Load (Colony Forming Units)
Tidsramme: 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).
Baseline (Day 14), Day 28, Day 49, and Day 70

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Biofilm Cell Viability via Flow Cytometry
Tidsramme: 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.
Baseline (Day 14), Day 28, Day 49, and Day 70
Biofilm Gene Expression
Tidsramme: 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.
Baseline (Day 14), Day 28, Day 49, and Day 70
Participant Satisfaction and Perception of Cleanliness
Tidsramme: 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).
Day 28, Day 49, and Day 70

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Sao Paulo

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

8. juni 2026

Primær færdiggørelse (Anslået)

14. september 2026

Studieafslutning (Anslået)

30. december 2027

Datoer for studieregistrering

Først indsendt

19. maj 2026

Først indsendt, der opfyldte QC-kriterier

19. maj 2026

Først opslået (Faktiske)

27. maj 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

27. maj 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • CAFOliveira
  • 2024/06375-0 (Anden identifikator: FAPESP)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

IPD-planbeskrivelse

To do not interrupt the patent process

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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