- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02078453
Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth (CARDEC-1)
2020년 5월 21일 업데이트: Fausto Medeiros Mendes, University of Sao Paulo
CARies DEtection in Children - Impact of the Radiographic Examination on Diagnosis and Treatment Decision of Caries Lesions in Primary Teeth
Radiographs have been used to aid dentists in detecting the presence of cavities in the deciduous teeth of children.
This procedure is globally recommended because the conventional clinical examination usually overlooks some cavities.
However, the real benefit of performing dental radiographs for this purpose is still unclear.
Besides the hazards of ionizing radiation, the radiographs could provoke overtreatment of the children; hence, dentists would tend to restore more teeth than would be really necessary.
Nowadays, it is preferable to overlook some cavities than treat the teeth unnecessarily.
Therefore, the investigators aimed to perform this study to compare two different strategies for detecting cavities in deciduous teeth of children: one based on clinical examination performed alone and other using radiographs adjunct to the clinical examination.
To compare these strategies, the investigators will consider outcomes related to children's health and welfare.
연구 개요
상세 설명
Despite most clinical guidelines throughout the world indicate that the clinicians take two bitewings for detecting caries lesions in primary molars of asymptomatic children, the evidence for this recommendation is based in cross-sectional studies performed in laboratorial setting or using convenience samples.
The benefits and impact of performing radiographs on diagnosis and treatment decision of caries lesions in primary teeth, considering relevant outcomes for the patients, have not been evaluated yet.
Thus, the aim of this study will be to evaluate the impact of performing radiographic examination for detecting caries lesions in primary teeth compared with the visual inspection performed alone, considering different outcomes related to the validity and children's health and welfare.
For this, three different studies will be carried out according the following specific aims: (1) to evaluate the validity of radiographic examination adjunct to the visual inspection in detecting proximal caries lesions in primary molars in children with low and high caries experience through a cross-sectional design; (2) to evaluate the impact of radiographic examination adjunct to the visual inspection on the diagnostic and treatment decision of caries lesions in primary teeth in a before and after study; and (3) to evaluate the impact of radiographic examination adjunct to the visual inspection for detecting caries lesions in primary teeth on operative needs in the follow-ups and impact of oral health on the quality of life through a randomized clinical trial.
To reach these objectives, 250 children aged 3 to 6 years who looked for dental treatment in our dental school will be randomly allocated in two groups according to the diagnostic strategy used for caries detection: visual inspection performed alone (control group) or visual inspection associated to radiographic examination (experimental group).
After elaboration of treatment decision plan for two examiners, the children will be treated and followed-up for 2 years, with evaluations after 12 and 24 months after the ingress of the children in the study.
The primary outcome will be the number of dental surfaces with dental treatment need in the follow-up, considering the aim (3).
Then, children allocated in the control group will be reevaluated using radiographic examination, and the performance of two strategies for detecting proximal caries lesions will be evaluated, using temporary separation with orthodontic rubbers for one week as reference standard method.
Moreover, a new treatment plan will be performed and compared with the treatment plan based on visual inspection alone.
These two parts of the research will be carried out to reach the aims (1) and (2), respectively.
Our working hypothesis is that the radiographic examination would actually exert little influence on outcomes related to the validity and children's health and welfare, and that visual inspection would be enough as diagnostic strategy for caries detection in primary teeth.
연구 유형
중재적
등록 (실제)
252
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Sao Paulo, 브라질, 05508-000
- School of Dentistry, University of Sao Paulo
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
3년 (어린이)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Children who sought dental treatment in our dental school (School of Dentistry, University of Sao Paulo, Sao Paulo, Brazil)
- Children aged 3 to 6 years
- Children with al least one primary molar in the mouth.
Exclusion Criteria:
- Children whose parents refuse to participate of the research
- Children presenting behavior problems during the treatment.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Visual inspection
Dental treatment performed according to the caries diagnosis obtained with visual inspection performed alone
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Dental treatment of all dental needs present in the children related or not to the dental caries.
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실험적: Radiographic examination
Dental treatment performed according to the caries diagnosis obtained with visual inspection and additional radiographic method.
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Dental treatment of all dental needs present in the children related or not to the dental caries.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of dental surfaces with operative treatment needs
기간: 24 months
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The number of dental surfaces with operative treatment needs after the follow-ups will be composed by number of surfaces with new caries lesions; number of restored surfaces with necessity of replacement; tooth with pain episode and/or necessity of endodontic treatment and tooth indicated for extraction.
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24 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Number of surfaces with new caries lesions
기간: 24 months
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Dental surfaces presenting caries lesions in the foloow-up examinations that require operative treatment.
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24 months
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Number of restored surfaces with necessity of replacement
기간: 24 months
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Number of restored dental surfaces that requires repair or replacement.
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24 months
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Episodes of dental pain and/or primary teeth with pulpal involvement
기간: 24 months
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Number of primary teeth that presented pain episodes or that require endodontic treatment in the follow-up examinations
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24 months
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Primary teeth indicated for extraction due to caries
기간: 24 months
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Number of primary teeth indicated for extraction due caries involvment.
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24 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Impact of Oral Health on quality of life
기간: 24 months
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Impact of Oral Health on quality of life of the children participants in the study, measured by a validated questionnaire (ECOHIS)
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24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Fausto M Mendes, PhD, School of Dentistry, University of Sao Paulo
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
일반 간행물
- Novaes TF, Pontes LRA, Freitas JG, Acosta CP, Andrade KCE, Guedes RS, Ardenghi TM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Responsiveness of the Early Childhood Oral Health Impact Scale (ECOHIS) is related to dental treatment complexity. Health Qual Life Outcomes. 2017 Sep 20;15(1):182. doi: 10.1186/s12955-017-0756-z.
- Pontes LRA, Novaes TF, Lara JS, Moro BLP, Gimenez T, Raggio DP, Braga MM, Mendes FM. Impact of the radiographic method on treatment decisions related to dental caries in primary molars: a before-after study. Clin Oral Investig. 2019 Nov;23(11):4075-4081. doi: 10.1007/s00784-019-02844-w. Epub 2019 Feb 18.
- Freitas JG, Pontes LRA, Acosta CP, Novaes TF, Lara JS, Gimenez T, Ardenghi TM, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Influence of two caries detection strategies on the quality of life of preschool children: An analysis of secondary outcomes of a 2-Year randomized clinical trial. Community Dent Oral Epidemiol. 2022 Jun 7. doi: 10.1111/cdoe.12765. Online ahead of print.
- Pontes LRA, Lara JS, Novaes TF, Freitas JG, Gimenez T, Moro BLP, Maia HCM, Imparato JCP, Braga MM, Raggio DP, Mendes FM; CARDEC collaborative group. Negligible therapeutic impact, false-positives, overdiagnosis and lead-time are the reasons why radiographs bring more harm than benefits in the caries diagnosis of preschool children. BMC Oral Health. 2021 Mar 31;21(1):168. doi: 10.1186/s12903-021-01528-w.
- Pontes LRA, Novaes TF, Lara JS, Gimenez T, Moro BLP, Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Mendes FM. Impact of visual inspection and radiographs for caries detection in children through a 2-year randomized clinical trial: The Caries Detection in Children-1 study. J Am Dent Assoc. 2020 Jun;151(6):407-415.e1. doi: 10.1016/j.adaj.2020.02.008.
- Mendes FM, Pontes LR, Gimenez T, Lara JS, de Camargo LB, Michel-Crosato E, Pannuti CM, Raggio DP, Braga MM, Novaes TF; CARDEC Collaborative Group. Impact of the radiographic examination on diagnosis and treatment decision of caries lesions in primary teeth--the Caries Detection in Children (CARDEC-01) trial: study protocol for a randomized controlled trial. Trials. 2016 Feb 9;17:69. doi: 10.1186/s13063-016-1196-5.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 3월 1일
기본 완료 (실제)
2018년 2월 1일
연구 완료 (실제)
2018년 2월 1일
연구 등록 날짜
최초 제출
2014년 2월 25일
QC 기준을 충족하는 최초 제출
2014년 3월 3일
처음 게시됨 (추정)
2014년 3월 5일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2020년 5월 26일
QC 기준을 충족하는 마지막 업데이트 제출
2020년 5월 21일
마지막으로 확인됨
2020년 5월 1일
추가 정보
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. .
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