이 페이지는 자동 번역되었으며 번역의 정확성을 보장하지 않습니다. 참조하십시오 영문판 원본 텍스트의 경우.

Cost-efficacy Between ART and Composite Resin Restorations in Primary Molars

2018년 12월 7일 업데이트: Daniela Prócida Raggio, University of Sao Paulo

Difference of Cost-efficacy Between Atraumatic Restoration Treatment (ART) and Composite Resin Restorations in Primary Molars: A Randomized Clinical Trial

The aim of this randomized clinical trial study is to compare the longevity of Atraumatic Restorative Treatment (ART) using high viscosity GIC and Conventional Treatment using composite resin under rubber dam isolation and local anesthesia (CT) in primary molars. As secondary outcomes, cost-efficacy, self-reported discomfort and cooperation will also be tested. Children aging between 3 to 6 years old presenting at least one occlusal and/or occlusoproximal cavity will be randomly assigned to one of two groups according to the dental treatment: ART (experimental group) or CT (control group). The dental treatment will be performed at a dental care trailer located in a Public School in Barueri (São Paulo, Brazil). The unit of analysis for randomization will be the child. A number of 204 teeth presenting occlusal cavities and 240 teeth presenting occlusoproximal cavities were set after sample size calculation. The primary outcome will be the restorations' longevity, which will be assessed after 6, 12, 18 and 24 months by two evaluators through clinical examination according to Frencken et al. (1998) criteria for occlusal restorations and Roeleveld et al. (2006) criteria for occlusoproximal restorations. The time spent during the dental treatment and all materials used will be considered for estimating the cost-efficacy of each treatment. The individual's discomfort will be also measured after each dental procedure using the Facial Scale of Wong-Baker. Cooperation will be assessed by the operator using a 5-point scale.

연구 개요

상태

알려지지 않은

정황

개입 / 치료

상세 설명

Research setting

The study will be performed in a dental care trailer which simulated a regular dental office and it is located inside a public school of the city Barueri (São Paulo, Brazil).

Sample size calculation

For sample size calculation, data regarding longevity of CT in occlusal and occlusoproximal restorations after 2 years were extracted from the literature as 86% for occlusal and 60% for occlusoproximal restorations. A difference of 15% and 20% between the longevity of CT and ART was set as non-inferiority limit. Considering the level of significance as 5%, power as 80% and adding 40% due to the study design (cluster per child), a number of 204 occlusal restorations and 240 occlusoproximal restorations will be needed.

Randomization

The child will be the unit of randomization which means that all eligible teeth of a participant will be treated according the same restorative approach. Randomization list will be obtained using blocks of 4, 6 and 8 generated by software Sealed Envelope Ltd. Opaque, sealed and sequentially numbered envelopes will be used for randomizing all participants immediately before restorative treatments' beginning.

Allocation concealment

To assure allocation concealment, the participant will be randomized immediately before the treatment. When two or more cavities is available, preventing the finalization of the treatment in only one session, breach of allocation concealment will be signalized in the participants' record.

Blinding

Due to differences between the techniques, it will be not possible to blind operators, participants and evaluators.

Operators

All operators will be masters or PhD students from the Pediatric Dentistry Department, Faculty of Dentistry, University of São Paulo, previously trained. All procedures will be performed with the assistance of a dental student previously trained to manipulate all restorative materials.

연구 유형

중재적

등록 (예상)

428

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 브라질
    • São Paulo
      • Barueri, São Paulo, 브라질
        • Complexo Educacional Carlos Osmarinho de Lima - Trailer USP

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

아니

연구 대상 성별

모두

설명

Inclusion Criteria:

  • Children aging between 3 and 6 years
  • presenting good health conditions
  • whose parents or legal guardians accept and sign the consent form
  • with at least one occlusal or occlusal proximal caries lesion in primary molars
  • only occlusal and/or occlusal-proximal surfaces with caries lesions with dentin involvement

Exclusion Criteria:

  • severe behavioral issues
  • presence of fistula or abscess near the selected tooth
  • presence of pulp exposure in the selected tooth
  • presence of mobility in the selected tooth

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 무작위
  • 중재 모델: 병렬 할당
  • 마스킹: 하나의

무기와 개입

참가자 그룹 / 팔
개입 / 치료
활성 비교기: Conventional Treatment
Occlusal and occlusoproximal composite resin restorations in primary molars (rubber dam isolation + Adhesive system + composite resin Filtek z350)
절차: Conventional Treatment
Occlusal and occlusoproximal composite resin restorations in primary molars using the Scotchbond Multi-purpose adhesive system and the Filtek Z-350 composite resin wil be performed. Local anesthesia will be used. Absolute isolation will be performed using rubber dam and clamp. Removal of unsupported enamel will be performed using a round bur. Infected carious tissue will be removed with hand instruments. The cavity will be etched using 37% phosphoric acid for 15 seconds followed by rising and drying for the same amount of time. The cavity will be restored with composite resin. Occlusion will be checked. an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.
실험적: ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars with GIC Fuji IX
절차: ART using Fuji IX
Occlusal and occlusoproximal ART restorations in primary molars using the high viscosity GIC Fuji IX will be performed under relative isolation. No local anesthesia will be used. Infected carious tissue will be removed with hand instruments, and the cavities restored with GIC. After the press-finger technique, the excess of material will be removed and occlusion will be checked. For occlusoproximal restoration, an adapted matrix strip with a wooden wedge will be used to assure appropriate contour.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
The restoration survival
기간: Every 6 months up to 24 months.
The treatments will be classified as successful when they present a clinical satisfactory aspect. Otherwise, "minor failures" will be analyzed. "Minor failures" are those in which there is a defect in the restoration/crown, but it does not interfere with the tooth health.
Every 6 months up to 24 months.

2차 결과 측정

결과 측정
측정값 설명
기간
Cost-efficacy assessment
기간: Through study completion, an average of 24 months

Treatment costs = professional costs + procedure costs.

  • Professional cost: the time spent in each session will be converted in hours and multiplied not only by the medium income of the dentist per hour added 40% of dangerousness but also by the medium income of a dental assistant added 20% of insalubrity
  • Procedure cost: variable cost (equipment & instruments depreciation and electricity) and and materials cost. To calculate the equipments' and instruments' depreciation, we will consider their price, the lifespan of 5 and 3 years respectively and a monthly use of 160 hours. To calculate materials' costs, all materials used in each procedure will have their specifications and quantity registered. Prices will be inferences from the market value converted in US Dollars obtained by the medium of the values from different places that commercialized the referred products.

If the restorative treatment requires repairs, the additional cost of it will also be considered.
Through study completion, an average of 24 months
Child self-reported discomfort
기간: Immediately after treatment
The acceptability of each type of treatment will be evaluated using the Facial scale of Wong-Baker (Wong; Baker, 1998). This scale indicates the discomfort of an individual who has to choose among six faces, each one expressing different facial countenance. The first image is a smiling happy face, indicating no discomfort, followed by gradually less cheerful expressions, up to the last one which is a very sad face covered by tears, indicating great discomfort. The participant will be asked to choose the face that is more similar to how he or she felt during the treatment. This answer should be given solely by the child, which means, no parental or professional interferences. The facial scale of Wong-Baker will be applied right after the end of each restorative treatment session.
Immediately after treatment
Cooperation
기간: Immediately after treatment
Cooperation will be evaluated by the operator immediately after the end of the treatment using a 5-point scale: 1- Good behaviour, 2- Reasonable behaviour, 3- Indiferent, 4- Bad behaviour, 5- Really bad behaviour.
Immediately after treatment

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

University of Sao Paulo

수사관

  • 연구 의자: Daniela P Raggio, PhD, 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

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 (실제)

2015년 11월 1일

기본 완료 (실제)

2018년 6월 10일

연구 완료 (예상)

2019년 12월 10일

연구 등록 날짜

최초 제출

2015년 9월 21일

QC 기준을 충족하는 최초 제출

2015년 9월 25일

처음 게시됨 (추정)

2015년 9월 29일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 12월 11일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 12월 7일

마지막으로 확인됨

2018년 12월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • RECART

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

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. .

Conventional Treatment에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Ethiopia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
구독하다