- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT07859553
Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents
Powered vs Manual Toothbrush Use: Its Effect on Caries Risk in Pre-Adolescents, A Pilot Study
This pilot study aims to evaluate dental caries experience in children ages 8-12 years old through comparing the use of a powered versus manual toothbrush, while using a standardized fluoride toothpaste as the control over the course of one year.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 연락처
- 이름: Taylor Cezon, RDH
- 전화번호: 734-730-8533
- 이메일: kidscavities@umich.edu
연구 장소
-
-
Michigan
-
Ann Arbor, Michigan, 미국, 48109
- 모병
- University of Michigan
-
수석 연구원:
- Margherita Fontana, DDS, PhD
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
-
Child:
- Male OR Female, between 8 - 12 years old at baseline
- In good health (i.e., free of any medical condition that would reasonably be anticipated to interfere with study participation)
- Must allow examination of the oral cavity at baseline
- Must have at least an ICDAS 2 or higher at baseline or radiographic signs of untreated caries lesions E2 or higher, or caries experience in the last 3 years (extraction due to caries, restoration due to caries, etc.)
- Able to tolerate radiographs
- Able to brush teeth by themselves with no assistance
Parent/Legal Guardian:
- Provide written informed consent for the child and her/himself prior to participation
- Must be at least 18 years old, or an emancipated minor who provides documentation of emancipation
- Must be willing and able to participate in study activities
Exclusion Criteria:
-
Child:
- Hereditary generalized developmental dental defects such as Amelogenesis Imperfecta and Dentinogenesis Imperfecta
- Presence of pain, pulpal exposure, or signs of pulpal infection (abscess, fistula, swelling) at baseline
- Participating in the foster care system
- Demonstrated inability to comply with study protocol requirements (including radiographs or abstaining from using other oral hygiene products such as mouth rinses during the study period)
- Has removable OR fixed orthodontic appliances
- Participation (within 30 days of Baseline Visit) in any other oral hygiene clinical study
Parent/Legal Guardian:
• Demonstrated inability to comply with trial protocol requirements
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: Manual Toothbrush
|
|
|
실험적: Powered Toothbrush
|
Powered toothbrush Oral-B iO Kids Electric Toothbrush Featuring Stitch |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of new caries surfaces and number of progressed caries surfaces
기간: 12 Months
|
Composite Endpoint. New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. Caries progression defined if baseline was enamel decay and follow-up was dentin decay, filling, or extracted due to caries. |
12 Months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Number of new caries surfaces
기간: 12 Months
|
New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. |
12 Months
|
|
Number of new caries surfaces and number of progressed caries surfaces
기간: 6 Months
|
Composite Endpoint. New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. Caries progression defined if baseline was enamel decay and follow-up was dentin decay, filling, or extracted due to caries. |
6 Months
|
|
Number of new caries surfaces
기간: 6 Months
|
New caries surface defined as baseline was sound (ICDAS=0 and no filling) and follow-up was enamel or dentin decay (ICDAS≥1), filling, or extracted due to caries. |
6 Months
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (추정된)
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
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Interested parties and contact the PI for potential collaboration
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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