Denture StomatitisDSRPDNCT07608211
Development of a Sanitizing Tablet for Removable Partial Dentures
A study testing Experimental Effervescent Tablet (NAC/Melaleuca), Commercial Cleansing Tablet (NitrAdine) and Phosphate-Buffered Saline (PBS) in people with Denture Stomatitis, run by University of Sao Paulo at 1 site in Brazil.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Denture Stomatitis
- What is being tested?
- Experimental Effervescent Tablet (NAC/Melaleuca), Commercial Cleansing Tablet (NitrAdine) and Phosphate-Buffered Saline (PBS)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteBrazil
- Study dates
- 8 Jun 2026to 30 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
School of Dentistry of Ribeirão Preto
Ribeirão Preto, São Paulo, 14051260
Carolina Alves Freiria de Oliveira, PhD student, +5535992436266, carolina.alves.oliveira@usp.br
About this study
Official title: 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.
- Conditions
- Denture Stomatitis
- Being tested
- Experimental Effervescent Tablet (NAC/Melaleuca), Commercial Cleansing Tablet (NitrAdine), Phosphate-Buffered Saline (PBS)
- Medical subject headings
- Stomatitis, Denture
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Experimental Effervescent Tablet (NAC/Melaleuca) |
| 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. Receives: Device: Commercial Cleansing Tablet (NitrAdine) |
| 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. Receives: Other: Phosphate-Buffered Saline (PBS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Baseline (Day 14), Day 28, Day 49, and Day 70
Secondary outcomes (3)
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.
Measured: Baseline (Day 14), Day 28, Day 49, and Day 70
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.
Measured: 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).
Measured: Day 28, Day 49, and Day 70
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 May 2026
- Study start8 Jun 2026 (estimated)
- Primary completion14 Sep 2026 (estimated)
- Study completion30 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Denture StomatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carolina Alves Freiria de Oliveira, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07608211
- Sponsor's protocol ID
- CAFOliveira
- Other IDs
- 2024/06375-0
- Acronym
- DSRPD
- Status last verified
- May 2026
- First submitted
- 19 May 2026
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: To do not interrupt the patent process
Publications
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.
PubMed 39331828Correa 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.
PubMed 41227976Freiria 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.
PubMed 40957068Freiria 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.
PubMed 38047547
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of a Denture Cleanser Tablet: Evaluation of Antibiofilm Activity and Effects on the Constituent Surfaces of Removable Partial Dentures.
- ClinicalTrials.gov ID
- NCT07608211
- Acronym / sponsor ID
- DSRPD / CAFOliveira
- Conditions
- Denture Stomatitis
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Study start
- 8 Jun 2026 (estimated)
- Primary completion
- 14 Sep 2026 (estimated)
- Study completion
- 30 Dec 2027 (estimated)
- First posted
- 27 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental Tablet (NAC/Melaleuca) | Experimental | Device: Experimental Effervescent 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. |
| Active Control (NitrAdine) | Active comparator | Device: Commercial Cleansing Tablet (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. |
| Placebo Control (PBS) | Placebo comparator | Other: Phosphate-Buffered Saline (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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Experimental Tablet (NAC/Melaleuca) |
| 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. | Device | Active Control (NitrAdine) |
| 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. | Other | Placebo Control (PBS) |
Primary outcome
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).
3 secondary outcomes
Biofilm Cell Viability via Flow Cytometry
Time frame: Baseline (Day 14), Day 28, Day 49, and Day 70
Biofilm Gene Expression
Time frame: Baseline (Day 14), Day 28, Day 49, and Day 70
Participant Satisfaction and Perception of Cleanliness
Time frame: Day 28, Day 49, and Day 70
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
- Background: PubMed 39331828Moraes 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.
- Background: PubMed 41227976Correa 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.
- Background: PubMed 40957068Freiria 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.
- Results publication: PubMed 38047547Freiria 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.
- Individual participant dataSharing planned: No. To do not interrupt the patent process
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental Effervescent Tablet (NAC/Melaleuca), Commercial Cleansing Tablet (NitrAdine) and Phosphate-Buffered Saline (PBS) in people with Denture Stomatitis, run by University of Sao Paulo at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Carolina Alves Freiria de Oliveira, PhD student (+5535992436266, carolina.alves.oliveira@usp.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microbial Load (Colony Forming Units) (time frame: Baseline (Day 14), Day 28, Day 49, and Day 70). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07608211, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jun 2026.