Development of a Sanitizing Tablet for Removable Partial Dentures

Официальное название

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

Обзор

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.

Вмешательства

• Устройство 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.
• Устройство 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.
• Другое 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.

Первичные конечные точки

• Microbial Load (Colony Forming Units) [Срок оценки: Baseline (Day 14), Day 28, Day 49, and Day 70]

Вторичные конечные точки (3)

• Biofilm Cell Viability via Flow Cytometry [Срок оценки: Baseline (Day 14), Day 28, Day 49, and Day 70]
• Biofilm Gene Expression [Срок оценки: Baseline (Day 14), Day 28, Day 49, and Day 70]
• Participant Satisfaction and Perception of Cleanliness [Срок оценки: Day 28, Day 49, and Day 70]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Да

Дизайн исследования

Распределение

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Двойное слепое

Основная цель

Поддерживающая терапия

Центры проведения

Бразилия · 1 центр

• School of Dentistry of Ribeirão Preto — Ribeirão Preto

Публикации

• 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. PMID 39331828
• Correa 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. PMID 41227976
• Freiria 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. PMID 40957068
• Freiria 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. PMID 38047547

Идентификаторы

NCT: NCT07608211 · CAFOliveira · 2024/06375-0

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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