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Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes

2 de noviembre de 2026 actualizado por: Mehtap Bilgin Çetin, Baskent University

This study compared two mouthwashes, containing hypochlorous acid (HOCl) or chlorhexidine (CHX), for their effects on dental plaque accumulation, gum bleeding, tooth staining, and bacteria in dental plaque. Participants used each mouthwash during a separate four-day period, with a washout period between treatments. Participants also evaluated their experience with each mouthwash using a questionnaire.

Descripción general del estudio

Descripción detallada

This single-center, randomized controlled crossover study compared mouthwashes containing 0.02% hypochlorous acid (HOCl) and 0.2% chlorhexidine (CHX) using a four-day plaque regrowth model. Thirty participants were enrolled, and 26 completed both treatment periods.

Each mouthwash was used twice daily, with 10 mL rinsed for one minute, during a four-day period. The treatment periods were separated by a 14-day washout period. Professional prophylaxis was performed at the beginning of each treatment period. Participants refrained from toothbrushing and interdental cleaning during the treatment periods.

Clinical assessments included the Modified Plaque Index, bleeding on probing, and the Modified Stain Index. Supragingival plaque samples were collected at the end of each treatment period for microbiological analysis, including bacterial colony counts and identification by MALDI-TOF mass spectrometry. Participants completed a questionnaire evaluating their experience with each mouthwash and indicated their final preference.

Tipo de estudio

Intervencionista

Inscripción (Actual)

30

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

      • Ankara, Turquía (Türkiye), 06000
        • Baskent University Faculty of Dentistry

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 65 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Sí

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Systemically healthy.
  • Aged 18-65 years.
  • Having at least 22 natural teeth.
  • Nonsmoker.
  • Willing to abstain from alcohol throughout the study.

Exclusion Criteria:

  • Presence of periodontitis or gingivitis.
  • Pregnancy or breastfeeding.
  • Use of medications that may affect periodontal status.
  • Antibiotic or anti-inflammatory medication use within the previous six months.
  • Use of antimicrobial mouth rinses, gels, or chewing gums within the previous three months.
  • Known allergy to any component of the study mouth rinses.
  • Presence of tongue conditions, such as geographic tongue or hairy tongue.
  • Periodontal probing depths of 4 mm or greater.
  • Gingival recession of 2 mm or greater.
  • Use of fixed or removable dental prostheses, including single crowns, or orthodontic appliances.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación cruzada
  • Enmascaramiento: Cuadruplicar

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: HOCl followed by CHX

Participants used 0.02% hypochlorous acid mouthwash for four days, followed by a 14-day washout period, and then 0.2% chlorhexidine gluconate mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.

Rinse with 10 mL for one minute, twice daily for four days.

Rinse with 10 mL for one minute, twice daily for four days.

Experimental: CHX followed by HOCl

Participants used 0.2% chlorhexidine gluconate mouthwash for four days, followed by a 14-day washout period, and then 0.02% hypochlorous acid mouthwash for four days. Each mouthwash was used twice daily, with 10 mL rinsed for one minute.

Rinse with 10 mL for one minute, twice daily for four days.

Rinse with 10 mL for one minute, twice daily for four days.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Modified Plaque Index
Periodo de tiempo: At the end of each four-day treatment period.

Dental plaque was assessed using the modified Silness and Löe Plaque Index at six sites per tooth. Each site was scored from 0 (no plaque) to 3 (abundant plaque). Mean scores were calculated for the full mouth and 12 anatomical regions and compared between the HOCl and CHX treatment periods. Mean scores range from 0 to 3; higher scores indicate greater plaque accumulation.

At the end of each four-day treatment period.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Total culturable bacterial count in supragingival plaque
Periodo de tiempo: At the end of each four-day treatment period.

Total culturable bacterial counts were measured in supragingival plaque samples collected from molar teeth and expressed as colony-forming units per milliliter (CFU/mL). Counts were compared between the HOCl and CHX treatment periods.

At the end of each four-day treatment period.
Bleeding on Probing (BOP)
Periodo de tiempo: At the end of each four-day treatment period.

Bleeding was assessed at six sites per tooth using a periodontal probe. Sites showing bleeding within 30 seconds after probing were recorded as positive. BOP was calculated as the number of bleeding sites divided by the total number of examined sites, multiplied by 100. Full-mouth and regional percentages were calculated. Scores range from 0% to 100%; higher values indicate more gingival bleeding.

At the end of each four-day treatment period.
Modified Stain Index (MSI)
Periodo de tiempo: At the end of each four-day treatment period.

Extrinsic tooth staining was assessed in four regions on each buccal and lingual/palatal tooth surface. Intensity was scored from 0 to 3. Area was scored from 1 to 3 only when intensity was 2 or 3, using the region-specific criteria of Macpherson et al. (2000). For intensity scores of 1, the intensity × area value was defined as 1. The participant-level MSI was calculated by averaging these values across examined regions, with a range of 0-9. Higher scores indicate greater staining.

At the end of each four-day treatment period.

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Participant-reported experience with mouthwashes
Periodo de tiempo: At the end of each four-day treatment period.

At the end of each treatment period, participants completed a five-item questionnaire assessing mouthwash taste, effects on taste perception, perceived tooth cleanliness, perceived tooth discoloration, and nausea associated with mouthwash use. Each item was rated as 1 (poor), 2 (moderate), or 3 (good). Higher scores indicate a more favorable participant rating. Each item was evaluated separately.

At the end of each four-day treatment period.
Final mouthwash preference
Periodo de tiempo: After completion of both four-day treatment periods and the intervening 14-day washout period.

After completing both treatment periods, participants indicated which of the two mouthwashes they preferred. The number of participants preferring each mouthwash was recorded.

After completion of both four-day treatment periods and the intervening 14-day washout period.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Mehtap Bilgin Cetin, Associate Professor, Baskent University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

28 de marzo de 2022

Finalización primaria (Actual)

19 de abril de 2022

Finalización del estudio (Actual)

19 de abril de 2022

Fechas de registro del estudio

Enviado por primera vez

29 de agosto de 2024

Primero enviado que cumplió con los criterios de control de calidad

5 de septiembre de 2024

Publicado por primera vez (Actual)

19 de septiembre de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

4 de noviembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

2 de noviembre de 2026

Última verificación

1 de noviembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

INDECISO

Descripción del plan IPD

A decision regarding sharing individual participant data has not yet been made.

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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