The Effect of Using Plaque-disclosing Tablets on the Effectiveness of Toothbrushing and Gingival Health in Children
Effect of Single-Use Plaque-Disclosing Tablet Reinforcement on Plaque Control and Gingival Health in Children: A Randomized Controlled Clinical Trial
This randomized controlled clinical trial evaluated whether a single at-home use of a plaque-disclosing tablet, as visual reinforcement following oral hygiene education, provides additional short-term benefits in plaque control and gingival health in children aged 10-14 years.
A total of 53 participants were randomized to a test group or a control group. All participants received plaque disclosure and standardized oral hygiene instruction including the modified Bass toothbrushing technique. Participants in the test group were additionally provided with one plaque-disclosing tablet to use on the fourth day after the initial visit, whereas the control group received no additional intervention. Plaque and gingival indices were recorded at baseline and again at the end of the first week.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
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Istanbul, Turquía (Türkiye)
- Istanbul Aydin University
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Children aged 10-14 years
- Systemically and mentally healthy
- No antibiotic use within the previous 3 months
- No use of oral mouthrinse within the previous 4 weeks
- No previous periodontal treatment
- No known allergy or hypersensitivity to any component of the plaque-disclosing agent
- Written informed consent provided by a parent or legal guardian
- Voluntary assent provided by the child
Exclusion Criteria:
- Presence of any systemic or mental condition that could interfere with participation
- Antibiotic use within the previous 3 months
- Use of oral mouthrinse within the previous 4 weeks
- History of periodontal treatment
- Known allergy or hypersensitivity to any component of the plaque-disclosing agent
- Refusal of parental/legal guardian consent or child assent
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Prevención
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Test
Standard oral hygiene education + baseline plaque disclosure + single plaque-disclosing tablet reinforcement on day 4. |
Participants received plaque disclosure followed by individualized visual feedback and standardized oral hygiene instruction using the modified Bass toothbrushing technique. Participants in the experimental arm were provided with one plaque-disclosing tablet and instructed to use it at home on the fourth day after the initial visit as a single visual reinforcement of the oral hygiene education. |
|
Comparador activo: Control
Standard oral hygiene education + baseline plaque disclosure only. |
Participants received plaque disclosure followed by individualized visual feedback and standardized oral hygiene instruction using the modified Bass toothbrushing technique. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Quigley-Hein Plaque Index
Periodo de tiempo: From enrollment to the end of treatment at 1 week
|
Plaque accumulation was assessed using the Quigley-Hein Plaque Index at the full-mouth level and separately for the incisor, canine, premolar, and molar regions. Scores were recorded at baseline and at the end of the first week. Lower scores indicate lower plaque accumulation. |
From enrollment to the end of treatment at 1 week
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change in Gingival Index
Periodo de tiempo: From enrollment to the end of treatment at 1 week
|
Gingival health was assessed using the Gingival Index at the full-mouth level. Scores were recorded at baseline and at the end of the first week. Lower scores indicate better gingival health. |
From enrollment to the end of treatment at 1 week
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Otros números de identificación del estudio
- 2023/27
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.
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