Avaliação da Carga do vírus SARS-CoV-2 na Cavidade Oral e na Saliva após desinfecção Com soluções Antimicrobianas Orais e dentifrícios.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 202
- 试验地点
- 1
- 主要终点
- Reduction of SARS-CoV-2 load in the oral mucosa and saliva
研究概览
简要总结
The aim of this study is to analyze if the use of oral antimicrobial solutions and dentifricies are able to reduce the SARS-CoV-2 load in the saliva and oral mucosa. It will be allocated hospitalized patients positive for SARS-CoV-2 (confirmed by RT-PCR of nasopharynx swab tests) and with signs and symptoms of COVID-19. These patients will be divided into two groups: patients enrolled in negative pressure rooms (NPR), and patients enrolled in intensive care units (ICU) with orotracheal intubation. These two groups will receive interventions with oral antimicrobial solutions or dentifrices, containing different compounds. Saliva and oral mucosa swabs will be collected before the intervention, immediately after the intervention, and after 30min and 1h. The primary outcome is to verify if these products can reduce the SARS-CoV-2 load in the saliva and oral mucosa at these time periods, detected by the measurement of the viral load and the fold-reduction.
详细描述
Each group of patients will receive specific interventions, as follows:
NPR group (n=60) - three interventions with different mouthwashes solutions (12 patients in each intervention): 1) 0.12% chlorhexidine solution (Colgate Periogard®); 2) mouthwash with 1.5% hydrogen peroxide solution (Colgate Peroxyl®); 3) mouthwash with 0.075% cetylpyridinium chloride solution (Colgate Total 12®); 4) 1.5% hydrogen peroxide solution plus 0.12% chlorhexidine solution (Colgate Peroxyl® followed by Colgate Periogard®).
The interventions will be compared with a Placebo, which will be a mouthwash with distilled water (n=12).
NPR group (n=90) - three interventions with different dentifrices (30 patients in each intervention): 1) dentifrice containing only 1.1% fluoride, water, glycerin, cellulose, sodium lauryl sulfate, and sodium bicarbonate; 2) dentifrice containing 0.32% fluoride, 0.96% zinc, arginine, poloxamer, glycerin, water, hydrated silica, sodium lauryl sulfate, and sodium saccharin 3) dentifrice containing 0.454% stannous fluoride, water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, microcrystalline cellulose, and xanthan gum .
The interventions will be compared to each other. ICU group (n=52)- two interventions with different oral antimicrobial solutions (26 patients in each intervention): 1) 0.12% chlorhexidine solution (Colgate Periogard®); 2) 1.5% hydrogen peroxide solution plus 0.12% chlorhexidine solution (Colgate Peroxyl® followed by Colgate Periogard®).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients positive for SARS-CoV-2 using the RT-PCR method and requiring oral hygiene care and other preventive and therapeutic dental procedures.
排除标准
- •Pediatric patients, negative for SARS-CoV-2 by the RT-PCR method, exhibiting oral ulcerations and other erosive lesions in the oral mucosa that contraindicate the use of hydrogen peroxide, chlorhexidine and cetylpyridinium, patients who present bleeding in the oral cavity. that prevents the collection of samples, patients who report a history of allergy, irritations or other side effects derived from the use of these substances, who do not adhere to the oral care protocols or those in which it is not possible to perform these procedures.
研究组 & 干预措施
Colgate Periogard and Peroxyl®
Patients hospitalized in the ICU with orotracheal intubation or negative pressure room - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution, following by a 0.12% non-alcoholic chlorhexidine solution
干预措施: Colgate Periogard® mouthwash (Other)
Colgate Periogard and Peroxyl®
Patients hospitalized in the ICU with orotracheal intubation or negative pressure room - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution, following by a 0.12% non-alcoholic chlorhexidine solution
干预措施: Colgate Peroxyl® mouthwash (Other)
Colgate Periogard®
Patients hospitalized in the ICU with orotracheal intubation or negative pressure room - will undergo antisepsia of the oral mucosa with 0.12% non-alcoholic chlorhexidine solution;
干预措施: Colgate Periogard® mouthwash (Other)
Colgate Peroxyl®
Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 1.5% hydrogen peroxide solution
干预措施: Colgate Peroxyl® mouthwash (Other)
Colgate Total 12®
Patients hospitalized in negative pressure rooms - will undergo antisepsia of the oral mucosa with 0.075% cetylpyridinium chloride associated with 0.28% zinc lactate
干预措施: Colgate Total® Mouthwash (Other)
Toothpaste with sodium monofluorophosphate
Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing only 1.1% fluoride, water, glycerin, cellulose, sodium lauryl sulfate, and sodium bicarbonate
干预措施: Toothpaste with sodium monofluorophosphate (Other)
Toothpaste with sodium fluoride and zinc
Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing 0.32% fluoride, 0.96% zinc, arginine, poloxamer, glycerin, water, hydrated silica, sodium lauryl sulfate, and sodium saccharin
干预措施: Toothpaste with sodium fluoride and zinc (Other)
Toothpaste with tin fluoride
Patients hospitalized in negative pressure rooms - will undergo brushing with dentifrice containing 0.454% stannous fluoride, water, sorbitol, hydrated silica, glycerin, tetrasodium pyrophosphate, microcrystalline cellulose, and xanthan gum
干预措施: Toothpaste with tin fluoride (Other)
结局指标
主要结局
Reduction of SARS-CoV-2 load in the oral mucosa and saliva
时间窗: 1 hour
Reduction of SARS-CoV-2 load in the oral mucosa and saliva measured by viral fold-reduction and viral quantitation
次要结局
未报告次要终点