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

2 giugno 2026 aggiornato da: 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.

Panoramica dello studio

Descrizione dettagliata

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 di studio

Interventistico

Iscrizione (Stimato)

70

Fase

  • Non applicabile

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

    • Antalya
      • Alanya, Antalya, Turchia (Türkiye), 07400
        • Alanya Alaaddin Keykubat University Faculty of Dentistry
        • Contatto:
        • Contatto:
          • Fatma Yaman Toktasır, Research Assistant, DDS
          • Numero di telefono: +905055881265
          • Email: yamanfatma07@gmail.com

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino

Accetta volontari sani

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Terapia di supporto
  • Assegnazione: Non randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Separare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: 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.
Comparatore attivo: 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.

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Lasso di tempo: 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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Lasso di tempo: 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
Lasso di tempo: 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

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2026

Date di iscrizione allo studio

Primo inviato

21 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

21 maggio 2026

Primo Inserito (Effettivo)

28 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

4 giugno 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

2 giugno 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Descrizione del piano IPD

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

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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