- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07611942
Plaque Removal Efficiency in Children With Specific Learning Disabilities (PRE-SLD)
Quantitative Analysis of Plaque Removal Efficiency in Children With Specific Learning Disabilities
연구 개요
상세 설명
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.
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: gül keskin, Associate Professor, DDS, PhD
- 전화번호: +905444468857
- 이메일: gul.keskin@alanya.edu.tr
연구 장소
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Antalya
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Alanya, Antalya, 터키 (Türkiye), 07400
- 모병
- Alanya Alaaddin Keykubat University Faculty of Dentistry
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연락하다:
- Gül Keskin, Associate Professor, DDS, PhD
- 전화번호: +90 242 510 61 40
- 이메일: gul.keskin@alanya.edu.tr
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연락하다:
- Fatma Yaman Toktasır, Research Assistant, DDS
- 전화번호: +905055881265
- 이메일: yamanfatma07@gmail.com
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
건강한 자원 봉사자를 받아들입니다
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 지지 요법
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Children With Specific Learning Disabilities
Children with specific learning disabilities receiving standardized toothbrushing education.
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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.
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활성 비교기: Healthy Control Children
Healthy children receiving standardized toothbrushing education.
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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.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in plaque percentage (P%) measured using ImageJ/FIJI analysis
기간: Baseline and 2 weeks
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Quantitative plaque percentage changes will be evaluated using disclosed plaque areas obtained from intraoral photographs before and after toothbrushing procedures.
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Baseline and 2 weeks
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Change in Plaque Index (Silness and Löe Plaque Index) Scores
기간: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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Change in Gingival Index (Löe and Silness Gingival Index) Scores
기간: Baseline and 2 weeks
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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.
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Baseline and 2 weeks
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- ALKU-PEDO-2025-10/1
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
구강 위생에 대한 임상 시험
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Sinai UniversityMenoufia University완전한
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Karolinska Institutet초대로 등록TMD | TMJ - 측두하악 관절의 반월판 손상 | TMJ- Oral & amp; Maxillofacial Surgery스웨덴
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Cancer Research UK종료됨인유두종바이러스(HPV) | Hypopharynx, Oropharynx, Oral Cavity, Supraglottis 또는 Larynx의 양성 또는 음성 두경부 편평 세포 암종(HNSCC)영국
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King Abdulaziz University모병측두하악 장애(TMD) | TMJ 통증 | 미술치료 | TMJ- Oral & amp; Maxillofacial Surgery | 윌크스 1과 2 | TMD 예술 통증 연구사우디 아라비아
Standardized Toothbrushing Education에 대한 임상 시험
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Chia-Tzu Line완전한
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Emine ErginSaglik Bilimleri Universitesi아직 모집하지 않음
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Academisch Medisch Centrum - Universiteit van Amsterdam...모집하지 않고 적극적으로월경통 | 생리주기 | 생리통 | 모바일 건강 | 심한 월경 출혈 | 생리통 | 생리통(월경통) | 일상 생활 | 월경 건강 개입 | 모바일 건강 기술(mHealth)네덜란드
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Second Affiliated Hospital, School of Medicine,...완전한
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University of SheffieldUniversity of Liverpool; University of Manchester; University of Melbourne모집하지 않고 적극적으로
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University of OxfordBeijing Normal University; Beijing Stars and Rain Education Institute for Autism완전한아동 학대 | 부모-자녀 관계 | 자폐 스펙트럼 장애 | 육아 | 아동 행동 문제 | 가족 관계 | 정신 건강 문제중국