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

University of Sao Paulo

Status: Not yet enrolling

Conditions: Denture Stomatitis

Treatments: Device: Experimental Effervescent Tablet (NAC/Melaleuca); Device: Commercial Cleansing Tablet (NitrAdine); Other: Phosphate-Buffered Saline (PBS)

Study type: Interventional

Funder types: Other

Identifiers

NCT07608211

CAFOliveira

2024/06375-0 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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15 participants in 3 patient groups, including a placebo group

Experimental Tablet (NAC/Melaleuca)

Experimental group

Description:

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.

Treatment:

Device: Experimental Effervescent Tablet (NAC/Melaleuca)

Active Control (NitrAdine)

Active Comparator group

Description:

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.

Treatment:

Device: Commercial Cleansing Tablet (NitrAdine)

Placebo Control (PBS)

Placebo Comparator group

Description:

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.

Treatment:

Other: Phosphate-Buffered Saline (PBS)