Taste Acceptance and Effectiveness of Hyaluronic Acid and Chlorhexidine Mouthwashes in Children With Gingivitis
Taste Acceptance and Clinical Effectiveness of Hyaluronic Acid Versus Chlorhexidine Mouthwashes in Children With Plaque-Induced Gingivitis: A Randomized Controlled Trial
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This study is a randomized, single-blind, controlled clinical trial designed to compare the taste acceptance and clinical effectiveness of a hyaluronic acid mouthwash and a chlorhexidine mouthwash in children aged 8 to 10 years with plaque-induced gingivitis.
Eligible participants will be recruited from the outpatient clinic and screened according to the study eligibility criteria. After obtaining informed consent from parents or legal guardians and assent from the children, baseline clinical assessments will be performed. Gingival inflammation will be evaluated using the Loe and Silness Gingival Index, and dental plaque accumulation will be assessed using the Silness and Loe Plaque Index.
Participants will be randomly assigned in a 1:1 ratio to one of two intervention groups. The intervention group will receive a hyaluronic acid mouthwash, while the control group will receive a chlorhexidine mouthwash. Allocation concealment will be maintained using sealed opaque envelopes prepared by an independent investigator. Clinical outcome assessment will be performed by a blinded examiner who will remain unaware of group allocation throughout the study period.
All participants will receive standardized oral hygiene instructions and identical instructions regarding mouthwash use. Participants will be instructed to use the assigned mouthwash twice daily for 14 days in addition to their routine toothbrushing practices.
Taste acceptance will be evaluated as the primary outcome using a validated facial hedonic scale following mouthwash use. Secondary outcomes will include changes in gingival inflammation and plaque accumulation, as measured by the Loe and Silness Gingival Index and the Silness and Loe Plaque Index, respectively.
Follow-up clinical examinations will be conducted after 14 days of intervention. Compliance with mouthwash use and any adverse events will be documented throughout the study period. The study aims to determine whether hyaluronic acid mouthwash provides comparable clinical effectiveness to chlorhexidine while demonstrating greater taste acceptance among children with plaque-induced gingivitis.
Tipo de estudio
Inscripción (Estimado)
Fase
- Fase 1
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Yasmeen AS Abdelqader, Bachelors
- Número de teléfono: +201018727929
- Correo electrónico: Yasmeen.saleh@dentistry.cu.edu.eg
Ubicaciones de estudio
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Egypt
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Cairo, Egypt, Egipto, 11411
- Faculty of Dentistry, Cairo University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
Acepta Voluntarios Saludables
Descripción
Inclusion Criteria:
- Children aged from 8-12 years of both sexes.
- Children with a history of bleeding on brushing typical signs and symptoms of gingivitis.
- Healthy child (ASA I).
- Eruption of upper and lower permanent central and lateral incisors.
- Parent's agreement to sign the informed consent.
- Parent's ability for attending follow up visits.
Exclusion Criteria:
- Children -allergic to Chlorhexidine or Hyaluronic acid.
- Children with special health care needs or having a history of serious systemic disease that may affect the gingival health.
- Use of Systemic NSAIDs, steroids, or antibiotics within a month before the study.
- Children undergoing orthodontic treatment or having an intra-oral prosthesis.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Experimental: Hyaluronic acid mouthwah
Participants in the experimental group will use a hyaluronic acid mouthwash (Q-Afta®, CIRA Pharma, Egypt).
The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 days.
And also not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing
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Q-Afta®, CIRA Pharma, Egypt
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Comparador activo: Chlorohexidine mouthwash
Participants in the control group will use a chlorohexidine mouthwash (Hexitol).
The principle investigator will instruct each participant to rinse with 10 mL of the mouthwash for 30-60 seconds twice daily after toothbrushing for a period of 14 day and not to swallow the mouthwash and to avoid eating or drinking for 30 minutes after rinsing.
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Hexitol®, 0.12% chlorhexidine gluconate; Arab Drug Company
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Taste acceptance
Periodo de tiempo: After 14 days of mouthwash administeration
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Taste acceptance will be assessed using a visual analog scale (VAS) of faces, rated from 1 to 5, where 1 represents very bad taste, and 5 represents very good taste
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After 14 days of mouthwash administeration
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Gingival index
Periodo de tiempo: At baseline before the study and after 14 days
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Gingival health will be measured by Löe & Silness gingival index
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At baseline before the study and after 14 days
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Plaque index
Periodo de tiempo: At baseline before the study and after 14 days
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Plaque index will be measured by Löe & Silness plaque index
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At baseline before the study and after 14 days
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Ola M Omar, Professor, Cairo University
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Estimado)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Enfermedades periodontales
- Enfermedades de la Boca
- Enfermedades Estomatognáticas
- Infecciones
- Enfermedades gingivales
- Gingivitis
- Acciones y usos químicos
- Materiales biomédicos y dentales
- Materiales manufacturados
- Tecnología, industria y agricultura
- Usos especializados de productos químicos
- Productos cosméticos
- Enjuague bucal
Otros números de identificación del estudio
- Mouthwashes for children-2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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