RBR-2phxzm Mouthwashes for treatment of nas breath

Date of registration: 08/17/2018 ^(mm/dd/yyyy)
Last approval date : 08/17/2018 ^(mm/dd/yyyy)

Study type:

Interventional

Scientific title:

Trial identification

• UTN code: U1111-1218-8709

• Public title:

  en

  Mouthwashes for treatment of nas breath

  pt-br

  Tratamento do mau hálito bucal com uso de enxaguante bucais

• Scientific acronym:

• Public acronym:
• Secondaries identifiers:
  • CAAE: 02122812.8.0000.5419
    Issuing authority: Plataforma Brasil
  • CEP: 940.915
    Issuing authority: Comitê de Ética em Pesquisa da Faculdade de Odontologia de Ribeirão Preto/FORP/USP

Sponsors

• Primary sponsor: Faculdade De Odontologia de Ribeirão Preto
• Secondary sponsor:
  • Institution: Faculdade De Odontologia de Ribeirão Preto
• Supporting source:
  • Institution: Conselho Nacional de Desenvolvimento Científico e Tecnológico

Health conditions

• Health conditions:

  en

  Halitosis; Mouthwashes; Bad breath; Morning breath.

  pt-br

  Halitose; Halitose matinal; Antissépticos bucais.

• General descriptors for health conditions:

  en

  K00-K93 XI - Diseases of the digestive system

  pt-br

  K00-K93 XI - Doenças do aparelho digestivo

• Specific descriptors:

Interventions

• Interventions:

  en

  The effectiveness of mouthwashes on the market, with alcohol and without alcohol, was evaluated in order to reduce the oral breath and to measure how long the effect was lasting, compared to a control with active principle. Four groups, controlled two by two, with a washout period between each one week intervention (7 days) were evaluated, considering the substantivity of chlorhexidine: Chlorhexidine digluconate (0.12%) - bis-biguanide (with alcohol-control), 21 participants, both genders; Chlorhexidine digluconate (0.12%) - bis-biguanide (no alcohol), 21 participants, both genders; Essential Oils (Thymol, Menthol, Eucalyptol, Methyl Salicylate) with alcohol and zinc chloride, 21 participants, both genders; Essential Oils (Thymol, Menthol, Eucalyptol and Methyl Salicylate) without alcohol, 21 participants, both genders.

  pt-br

  Avaliou-se a eficácia de enxaguantes bucais do mercado, com álcool e sem álcool, em reduzir o hálito bucal e mensurar por quanto tempo o efeito foi duradouro, em comparação a um controle com princípio ativo. Os enxaguantes bucais foram usados apenas uma vez por participante, em uso tópico. Foram avaliados 4 grupos, controlados dois a dois, com período de washout entre cada intervenção de uma semana (7 dias), considerando-se a substantividade da clorexidina: Digluconato de Clorexidina (0,12%) – bis-biguanida (com álcool - controle), 21 participantes, ambos gêneros; Digluconato de Clorexidina (0,12%) – bis-biguanida (sem álcool), 21 participantes, ambos gêneros; Óleos Essenciais (Timol, Mentol, Eucaliptol, Salicilato de Metila) com álcool e cloreto de zinco, 21 participantes, ambos gêneros; Óleos Essenciais (Timol, Mentol, Eucaliptol e Salicilato de Metila) sem álcool, 21 participantes, ambos gêneros.

• Descriptors:

  en

  D02.078.370.141.100 Chlorhexidine

  pt-br

  D02.078.370.141.100 Clorexidina

  es

  D02.078.370.141.100 Clorhexidina

  en

  D10.627.675 Oils, Volatile

  pt-br

  D10.627.675 Óleos Voláteis

  es

  D10.627.675 Aceites Volátiles

Recruitment

• Study status: Data analysis completed
• Countries
  • Brazil
• Date first enrollment: 04/04/2012 ^(mm/dd/yyyy)

• Target sample size:	Gender:	Minimum age:	Maximum age:
  21	-	12 Y	50 Y

• Inclusion criteria:

  en

  Presence of at least 20 natural teeth; Good oral hygiene; Absence of periodontal disease, xerostomia, or any chronic inflammatory process; Patients with halitosis of intra-oral cause.

  pt-br

  Presenca de no minimo 20 dentes naturais; Boa higiene bucal; Ausência de doença periodontal, xerostomia, ou qualquer processo inflamatório crônico; Pacientes portadores de halitose de causa intra-oral.

• Exclusion criteria:

  en

  Smokers; Alchoolics; Pregnant or lactating; Carriers of systemic diseases (hepatic, renal, diabetes); Presence of pharyngeal or tonsillar infection; Upper or lower respiratory tract inflammation; Carriers of removable prostheses, clinically unsatisfactory fixed prostheses, dental caries, lesions on the buccal mucosa; Individuals who have used antibiotics in the last 3 months.

  pt-br

  Tabagistas; Etilistas; Grávidas ou lactantes; Portadores de doenças sistêmicas (hepática, renal, diabetes); Presença de infecção faringeana ou tonsilar; Inflamações do trato respiratório superior ou inferior; Portadores de próteses removiveis, próteses fixas insatisfatórias clinicamente, cáries dentais, lesões na mucosa bucal; Indivíduos que fizeram uso de antibióticos nos últimos 3 meses.

Study type

• Study design:

• Expanded access program	Purpose	Intervention assignment	Number of arms	Masking type	Allocation	Study phase
  	Treatment	Cross-over	4	Triple-blind	Randomized-controlled	N/A

Outcomes

• Primary outcomes:

  en

  Reduction or elimination of oral halitosis with mouthwashes with and without alcohol.

  pt-br

  Redução ou eliminação das halitoses bucais com uso de enxaguantes bucais com e sem álcool.

  en

  Only the product with the essential oils, alcohol and zinc chloride in its formula was effective for reducing breath.

  pt-br

  Somente o produto com os óleos essenciais, álcool e cloreto de zinco em sua fórmula foi eficaz para redução do hálito.

• Secondary outcomes:

  en

  Non-alcoholic mouthwashes are expected to reduce oral halitosis more effectively than those with alcohol in the composition.

  pt-br

  Espera-se que os enxaguantes bucais sem álcool reduzam as halitoses de origem bucal com mais eficácia que aqueles com álcool na composição.

  en

  The alcohol-free mouthwashes obtained the worst results, and the essential oils allowed the initial values of halitosis to increase after 3 hours.

  pt-br

  Os enxaguantes sem álcool obtiveram os piores resultados, sendo que os óleos essenciais possibilitaram o aumento dos valores iniciais da halitose ao final de 3 horas.

Attachments

• OLIVEIRA-NETO JM. Effect of mouthrinses on halitosis: randomized crossover controlled trial, 2014. 135p. Tese (Doutorado em Reabilitação Oral). Faculdade de Odontologia de Ribeirão Preto, Universidade de São Paulo. ABSTRACT: Hydrogen sulfide (H2S) is recently known as a very important gasotransmitter with neuroprotectant, antioxidant, anti-inflammatory, vasodilator, angiogenic and antiapoptotics functions both in physiological and pathological conditions. When methylated, produces methanethiol (CH3SH), and both are the most offensive gases responsible for intra-oral halitosis. This crossover clinical trial evaluated the effectiveness of chlorhexidine (CHX) or essential oils (EO) based mouthrinses for reduction of H2S and CH3SH levels. 21 adult subjects (8 male, 13 female) were randomly allocated into a four period crossover trial. Four mouthrinses were tested: Periogard® with alcohol (positive control) (CHXw/a) and without alcohol (CHXn/a); ListerineTotal® (EOw/a) and ListerineZeroTM (EOn/a) arranged into four sequences of use. All the volunteers were asked to refrain from oral hygiene for a 12-hours period for baseline scores. Each product was used at once, followed by a one-week washout period. The breath was measured by portable gas chromatograph OralChroma™ before rinsing and after 1, 2 and 3 hours. Exploratory analysis of data through measures of central location and dispersion was performed. Comparisons of the means of the variables were made by linear mixed effect model for longitudinal data by using PROC MIXED from SAS® 9.2 software. Compared to the baseline, at the first hour, only EOw/a was able to significantly reduce the breath (H2S p<0.0001 and CH3SH p=0.001) for both gases and its effect lasted for up to three hours (H2S p<0.0001 and CH3SH p=0.001). CHXw/a(control) reduced H2S at the first hour (p=0.001) and lasted for three hours (H2S p<0.0001) without effect on CH3SH. CHXn/a just reduced H2S levels but less effectively at the whole period (p=0.001 for the 3 times). EOn/a had no effect on breath, which increased with time for both gases. The EOw/a presented the best performance against intra-oral halitosis followed by the control CHXw/a and CHXn/a. Keywords: Halitosis, mouthrinses, gas chromatography, Crossover clinical trial. Acknowledgment: CNPq (143061/2011-9)
• Parecer CEP via Plataforma Brasil - APROVAÇÃO FINAL

Contacts

• Public contact
  • Full name: Vinicius Pedrazzi
  • • Address: Av. do Café, s/nº
    • City: Ribeirão Preto / Brazil
    • Zip code: 14040-904
  • Phone: +55 16 3315-4008
  • Email: pedrazzi@forp.usp.br
  • Affiliation: Faculdade De Odontologia de Ribeirão Preto
   
• Scientific contact
  • Full name: Vinicius Pedrazzi
  • • Address: Av. do Café, s/nº
    • City: Ribeirão Preto / Brazil
    • Zip code: 14040-904
  • Phone: +55 16 3315-4008
  • Email: pedrazzi@forp.usp.br
  • Affiliation: Faculdade De Odontologia de Ribeirão Preto
   
• Site contact
  • Full name: Vinicius Pedrazzi
  • • Address: Av. do Café, s/nº
    • City: Ribeirão Preto / Brazil
    • Zip code: 14040-904
  • Phone: +55 16 3315-4008
  • Email: pedrazzi@forp.usp.br
  • Affiliation: Faculdade De Odontologia de Ribeirão Preto
   

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