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Plaque Removal Efficiency in Children With Specific Learning Disabilities (PRE-SLD)

15 de junio de 2026 actualizado por: Gül Keskin, Alanya Alaaddin Keykubat University

Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities

This study aims to evaluate the effectiveness of toothbrushing education on plaque removal in children aged 7-12 years with specific learning disabilities (SLD) and to compare their plaque removal performance with healthy children. Participants will receive standardized toothbrushing education supported by visual and auditory materials. Plaque Index, Gingival Index, and photograph-based quantitative plaque analyses will be evaluated at baseline and after a 2-week follow-up period.

Descripción general del estudio

Descripción detallada

Dental plaque is one of the major etiological factors associated with oral diseases such as dental caries and gingival inflammation. Effective plaque control through proper toothbrushing habits plays an important role in maintaining oral health in children. However, children with specific learning disabilities (SLD) may experience difficulties in acquiring and maintaining adequate oral hygiene behaviors because of limitations in learning processes, attention, and motor coordination.

The aim of this study is to evaluate the short-term effectiveness of structured toothbrushing education in children aged 7-12 years with SLD and to compare plaque removal performance with healthy children using photograph-based quantitative analysis methods.

The study will be conducted at the Department of Pediatric Dentistry, Faculty of Dentistry, Alanya Alaaddin Keykubat University. Children diagnosed with SLD and age-matched healthy controls will be included in the study. All participants will receive standardized toothbrushing education supported by visual cards and educational videos. Educational materials will be prepared in a child-friendly format and based on the Modified Bass toothbrushing technique.

A plaque-disclosing agent will be applied to all participants to visualize dental plaque before photography. Intraoral photographs will be obtained under standardized conditions using the same lighting, camera settings, and imaging protocol. At each evaluation session, intraoral photographs will be obtained both before and after toothbrushing in order to assess immediate plaque removal effectiveness. Quantitative plaque analysis will be performed using ImageJ/FIJI software by calculating plaque percentage (P%) values from disclosed plaque areas.

Participants will use standardized toothbrushes and toothpaste throughout the study period. During the 2-week follow-up period, children will be encouraged to continue toothbrushing under parental supervision using the taught brushing technique. At follow-up visits, Plaque Index, Gingival Index, plaque disclosure, and intraoral photography procedures will be repeated to evaluate changes in plaque removal effectiveness and oral hygiene performance.

The findings of this study are expected to contribute to the development of individualized oral hygiene education approaches for children with specific learning disabilities and to support the use of photograph-based quantitative plaque analysis methods in pediatric dentistry research.

Tipo de estudio

Intervencionista

Inscripción (Estimado)

70

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.

Estudio Contacto

  • Nombre: gül keskin, Associate Professor, DDS, PhD
  • Número de teléfono: +905444468857
  • Correo electrónico: gul.keskin@alanya.edu.tr

Ubicaciones de estudio

    • Antalya
      • Alanya, Antalya, Turquía (Türkiye), 07400
        • Reclutamiento
        • Alanya Alaaddin Keykubat University Faculty of Dentistry
        • Contacto:
          • Gül Keskin, Associate Professor, DDS, PhD
          • Número de teléfono: +90 242 510 61 40
          • Correo electrónico: gul.keskin@alanya.edu.tr
        • Contacto:
          • Fatma Yaman Toktasır, Research Assistant, DDS
          • Número de teléfono: +905055881265
          • Correo electrónico: yamanfatma07@gmail.com

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

  • Niño

Acepta Voluntarios Saludables

Sí

Descripción

Inclusion Criteria:

  • Diagnosis of specific learning disabilities confirmed by a child and adolescent psychiatry specialist for the study group
  • Confirmation by a child and adolescent psychiatry specialist that the control group participants are healthy and do not have any psychiatric diagnosis
  • Age between 7 and 12 years
  • Written informed consent obtained from parents or legal guardians

Exclusion Criteria:

  • Children with additional psychiatric diagnoses such as autism spectrum disorder, attention deficit/hyperactivity disorder, or intellectual disability
  • Children with systemic health problems or physical disabilities that may interfere with participation in the study

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: Cuidados de apoyo
  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Children With Specific Learning Disabilities
Children with specific learning disabilities receiving standardized toothbrushing education.
Participants will receive standardized toothbrushing education supported by visual educational cards and educational videos based on the Modified Bass toothbrushing technique. The education program will include step-by-step practical instruction, mirror-assisted self-modeling, and parental involvement. Standardized toothbrushes and toothpaste will be provided to all participants. Plaque removal effectiveness will be evaluated using plaque-disclosing agents, intraoral photographs obtained before and after toothbrushing, and quantitative plaque analysis performed with ImageJ/FIJI software.
Comparador activo: Healthy Control Children
Healthy children receiving standardized toothbrushing education.
Participants will receive standardized toothbrushing education supported by visual educational cards and educational videos based on the Modified Bass toothbrushing technique. The education program will include step-by-step practical instruction, mirror-assisted self-modeling, and parental involvement. Standardized toothbrushes and toothpaste will be provided to all participants. Plaque removal effectiveness will be evaluated using plaque-disclosing agents, intraoral photographs obtained before and after toothbrushing, and quantitative plaque analysis performed with ImageJ/FIJI software.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Periodo de tiempo: Baseline and 2 weeks
Quantitative plaque percentage changes will be evaluated using disclosed plaque areas obtained from intraoral photographs before and after toothbrushing procedures.
Baseline and 2 weeks

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Periodo de tiempo: Baseline and 2 weeks
Plaque accumulation will be assessed using the Silness and Löe Plaque Index. The index ranges from 0 to 3. A score of 0 indicates no plaque. A score of 1 indicates a thin film of plaque adhering to the free gingival margin and adjacent area of the tooth, detectable only by running a probe across the tooth surface. A score of 2 indicates moderate accumulation of soft deposits visible to the naked eye on the tooth surface and gingival margin. A score of 3 indicates abundant soft deposits within the gingival pocket and/or on the tooth and gingival margin. Higher scores indicate poorer oral hygiene and greater plaque accumulation. Changes will be evaluated at baseline and after the 2-week toothbrushing education period.
Baseline and 2 weeks
Change in Gingival Index (Löe and Silness Gingival Index) Scores
Periodo de tiempo: Baseline and 2 weeks
Gingival health will be assessed using the Löe and Silness Gingival Index. The index ranges from 0 to 3. A score of 0 indicates healthy gingiva with no signs of inflammation. A score of 1 indicates mild inflammation characterized by slight color change and edema without bleeding on probing. A score of 2 indicates moderate inflammation characterized by redness, edema, and bleeding on probing. A score of 3 indicates severe inflammation characterized by marked redness, edema, ulceration, and a tendency toward spontaneous bleeding. Higher scores indicate poorer gingival health and more severe gingival inflammation. Changes in Gingival Index scores will be evaluated at baseline and after the 2-week toothbrushing education period.
Baseline and 2 weeks

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este 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)

15 de junio de 2026

Finalización primaria (Estimado)

1 de octubre de 2026

Finalización del estudio (Estimado)

1 de octubre de 2026

Fechas de registro del estudio

Enviado por primera vez

21 de mayo de 2026

Primero enviado que cumplió con los criterios de control de calidad

21 de mayo de 2026

Publicado por primera vez (Actual)

28 de mayo de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

16 de junio de 2026

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

15 de junio de 2026

Última verificación

1 de junio de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Descripción del plan IPD

Individual participant data (IPD) will not be shared due to participant confidentiality and privacy considerations.

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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