- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07611942
Plaque Removal Efficiency in Children With Specific Learning Disabilities (PRE-SLD)
Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiekontakt
- Navn: gül keskin, Associate Professor, DDS, PhD
- Telefonnummer: +905444468857
- E-mail: gul.keskin@alanya.edu.tr
Studiesteder
-
-
Antalya
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Alanya, Antalya, Tyrkiet (Türkiye), 07400
- Alanya Alaaddin Keykubat University Faculty of Dentistry
-
Kontakt:
- Gül Keskin, Associate Professor, DDS, PhD
- Telefonnummer: +90 242 510 61 40
- E-mail: gul.keskin@alanya.edu.tr
-
Kontakt:
- Fatma Yaman Toktasır, Research Assistant, DDS
- Telefonnummer: +905055881265
- E-mail: yamanfatma07@gmail.com
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
Tager imod sunde frivillige
Beskrivelse
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
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Støttende pleje
- Tildeling: Ikke-randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: 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.
|
|
Aktiv komparator: 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.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Change in Plaque Index (Silness and Löe Plaque Index) Scores
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- ALKU-PEDO-2025-10/1
Plan for individuelle deltagerdata (IPD)
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IPD-planbeskrivelse
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