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

15 de junho de 2026 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Intervencional

Inscrição (Estimado)

70

Estágio

  • Não aplicável

Contactos e Locais

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Contato de estudo

Locais de estudo

    • Antalya
      • Alanya, Antalya, Turquia (Türkiye), 07400
        • Recrutamento
        • Alanya Alaaddin Keykubat University Faculty of Dentistry
        • Contato:
        • Contato:
          • Fatma Yaman Toktasır, Research Assistant, DDS
          • Número de telefone: +905055881265
          • E-mail: yamanfatma07@gmail.com

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Filho

Aceita Voluntários Saudáveis

Sim

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Cuidados de suporte
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
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 Ativo: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Prazo: 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 resultados secundários

Medida de resultado
Descrição da medida
Prazo
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Prazo: 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
Prazo: 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

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

15 de junho de 2026

Conclusão Primária (Estimado)

1 de outubro de 2026

Conclusão do estudo (Estimado)

1 de outubro de 2026

Datas de inscrição no estudo

Enviado pela primeira vez

21 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

21 de maio de 2026

Primeira postagem (Real)

28 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de junho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

15 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Descrição do plano IPD

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

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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