감염성 심내막염으로 입원한 환자의 12개월 구강 건강 상태에 대한 CBCT 대 OPT. (3D STARS)
감염성 심내막염으로 입원한 환자의 12개월 구강 건강 상태에 대한 3D 영상(원추빔 컴퓨터 단층촬영)과 Orthopantomogram 비교: 다기관 무작위 우월성 대조 시험.
1. Infective Endocarditis (IE) is a rare and serious disease with high morbidity and mortality; 2. Streptoccoci of oral origin are the second more frequent microorganisms responsible for IE; 3. Oral Infectious Foci (OIF) are underdetected using the current recommended clinical examination/Orthopantomogram (OPT) approach; 4. Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF than OPT; 5. To date, no study has been performed to assess the potential benefit of a clinical examination/CBCT approach on the oral health status in IE patients.
Thus, conducting a randomized controlled trial is highly desirable to assess the potential impact of a clinical examination/CBCT approach on the oral health status of patients hospitalized for IE and potentially to reduce IE new episodes.
연구 개요
연구 유형
등록 (추정된)
단계
- 해당 없음
연락처 및 위치
연구 장소
-
-
-
Bordeaux, 프랑스
- 모병
- CHU Bordeaux - Site Pellegrin
-
연락하다:
- Elise ARRIVE
- 전화번호: +33/5 56 79 56 79
- 이메일: elise.arrive@u-bordeaux.fr
-
Clermont-Ferrand, 프랑스
- 모병
- CHU Clermont-Ferrand
-
연락하다:
- Magali VIDAL
- 전화번호: +33473754405
- 이메일: mvidal@chu-clermontferrand.fr
-
Grenoble, 프랑스
- 모병
- CHU Grenoble
-
연락하다:
- Cécile CHATEL
- 전화번호: +33/4 76 76 50 26
- 이메일: cchatel1@chu-grenoble.fr
-
Lyon, 프랑스
- 모병
- HCL
-
연락하다:
- Sarah MILLOT GUARD
- 전화번호: +33426680250
- 이메일: sarah.millot-guard@chu-lyon.fr
-
Marseille, 프랑스
- 모병
- APHM
-
연락하다:
- Jean-Hugues CATHERINE
- 전화번호: +33676320760
- 이메일: jean-hugues.catherine@ap-hm.fr
-
Nancy, 프랑스
- 모병
- CHRU Nancy
-
연락하다:
- Vanessa MOBY
- 전화번호: +33/3 83 39 18 00
- 이메일: vanessa.moby@univ-lorraine.fr
-
Nantes, 프랑스
- 모병
- CHU Nantes
-
연락하다:
- Astrid GARREAU
- 이메일: astrid.garreau@chu-nantes.fr
-
연락하다:
- Alexandra CLOITRE
- 전화번호: +33/2.40.41.29.85
- 이메일: alexandra.cloitre@univ-nantes.fr
-
Paris, 프랑스
- 모병
- AP-HP - Site Bretonneau
-
연락하다:
- MESSECA Clément
- 전화번호: +33/1 53 11 18 00
- 이메일: clement.messeca@aphp.fr
-
Toulouse, 프랑스
- 모병
- CHU Toulouse
-
연락하다:
- Sarah COUSTY
- 전화번호: +33/5.61.32.20.30
- 이메일: cousty.s@chu-toulouse.fr
-
Tours, 프랑스
- 모병
- CHRU Tours
-
연락하다:
- Frédéric DENIS
- 전화번호: +33/2 47 47 47 47
- 이메일: frederic.denis@univ-tours.fr
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Patients hospitalized or recently hospitalized for definite IE according to the 2015 ESC classification, naive patients for dental examination and imaging, whatever the IE responsible microorganism;
- Patients with a stable clinical state, meaning stabilized IE patients out of the critical phase, compatible with the performance of an OPT and a CBCT;
- Patients whose life expectancy is expected to be longer than 6 months;
- Patients who agree to visit the dental department of the hospital to carry out OIF eradication or at his/her personal dentist;
- Patients over 18 years old;
- Patients affiliated to a Social Security or a health insurance scheme;
- Patients who have given informed consent to participate to the study.
Exclusion Criteria:
- OPT or CBCT already performed before the inclusion of the patients in the study and available for the investigator during the patient's hospitalization.
- Medical contraindications to perform OPT or CBCT imaging;
- Absence of microbiologic identification of the IE responsible microorganism;
- Pregnant or breastfeeding women;
- Patients unable to give informed consent to participate to the study (under trusteeship, guardianship and legal protection).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
간섭 없음: OPT
Orthopantomogram = current recommended clinical examination approach (comparator procedure) |
|
|
실험적: CBCT
Cone Beam Computed Tomography = experimental clinical examination approach (procedure under evaluation) |
Cone Beam Computed Tomography (CBCT) has a better sensitivity and sensibility to detect OIF. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Superiority of CBCT
기간: Month 12
|
Number of oral infectious foci detected using orthopantomogram versus Cone Beam Computer Tomography |
Month 12
|
|
Superiority of CBCT
기간: Month 12
|
DFMT index comprising the number of decayed, filled and missing teeth |
Month 12
|
|
Superiority of CBCT
기간: Month 12
|
Number of severe periodontitis sites |
Month 12
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Diagnostic at inclusion
기간: Day 0
|
Determine the diagnostic impact of clinical examination combined with CBCT at inclusion visit (Number of OIF detected at inclusion visit through clinical examination and CBCT versus clinical examination and OPT). |
Day 0
|
|
Incident symptomatic OIF
기간: Month 12
|
Monitor incident symptomatic OIF occuring during the study impacting the initial personalized OIF management (Number of incident symptomatic OIF detected during the study). |
Month 12
|
|
Incident asymptomatic OIF
기간: Month 12
|
Monitor incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but identified at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT (Number of incident asymptomatic OIF occuring during the study i.e. OIF absent at the initial examination but detected at the ultimate visit without symptomatic episode, in patients subjected to a clinical oral examination coupled with a CBCT). |
Month 12
|
|
Oral hygiene
기간: Day 0 and Month 12
|
Evaluate the oral hygiene of the IE patients included in the study (Oral hygiene using the Oral Hygiene Index- Simplified score (OHI-S) at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
|
|
Follow-up habits
기간: Day 0 and Month 12
|
Evaluate the follow-up habits of the IE patients included in the study by number of dental visits per year at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
|
|
Follow-up habits
기간: Day 0 and Month 12
|
Evaluate the follow-up habits of the IE patients included in the study by number of dental brushings per day (specific questionnaire already validated in French version) at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
|
|
Oral health quality of life
기간: Day 0 and Month 12
|
Assess the oral health quality of life of the IE patients included in this study (Oral health quality of life using by the short version of the self-administrated Oral Health impact profile-14 questionnaire (OHIP-14), at inclusion visit and at the end-of-study visit). |
Day 0 and Month 12
|
|
Premature end of study
기간: Month 12
|
Analyse the patient's premature end of study (Causes of the patient's premature end of study: loss to follow-up, death, patient withdrawing consent). |
Month 12
|
|
Impact of dental OIF
기간: Month 12
|
Number of dental OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
|
|
Impact of periodontal OIF
기간: Month 12
|
Number of periodontal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
|
|
Impact of mucosal OIF
기간: Month 12
|
Number of mucosal OIF detected at the end-of-study visit through clinical examination versus number of periodontal OIF detected at the inclusion visit through clinical examination. |
Month 12
|
공동 작업자 및 조사자
간행물 및 유용한 링크
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 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. .