Bacteremia in Periodontal Patients
2014년 8월 11일 업데이트: University of Taubate
Influence of Pre-procedural Oral Rinse in the Induced Bacteremia by Periodontal Instrumentation: a Randomized Clinical Trial
Bacteremia represents the presence of live germs in the blood stream.
Patients with gum disease show damaged tissues and seem to be more susceptible to bacteremia.
In fact, daily activities such as mastication can induce bacteremia in these patients.
Dental procedures related to bleeding also induce bacteremia.
However, there are many questions that should be clarified.
Among them, clinical strategies that are able to reduce the levels of germs in blood should be determined.
This desirable effect could be particularly important for some patients, for example, for those at higher risk for endocarditis.
Therefore, this study tested if 0.12% chlorhexidine solution used as a single mouth rinse before dental instrumentation could reduce the levels of bacteria in the blood.
In addition, the occurrence and magnitude of bacteremia in patients with gum disease were investigated by two different laboratorial techniques.
After receiving verbal and written explanations and after signed the informed consent form, 80 systemically healthy volunteers diagnosed with gum disease having dental plaque and tartar were randomly allocated in one the following groups: a) mouth-rinse use and dental instrumentation and b) dental instrumentation with no mouth rinse.
In a preliminary visit volunteers underwent a complete periodontal examination which included clinical measurements (inflammatory and debris accumulation indicators), microbial (tongue and dental plaque samples collected with paper points), saliva (to determine volume and biological indicators) and gingival crevicular fluid sampling (to monitor gingival inflammation profile).
In the next visit, dental instrumentation was performed under local anesthesia, after the mouth rinse single use in the most diseased periodontal teeth/quadrant.
Blood samples were collected before any dental procedure, 2 and 6 minutes after dental instrumentation.
Oral hygiene instructions and periodontal treatment were performed in additional visits according to individual needs.
Finally, the relation between bacteremia and several indicators of periodontal status was investigated.
연구 개요
연구 유형
중재적
등록 (실제)
80
단계
- 4단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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SP
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Taubate, SP, 브라질, 12020330
- Nucleus of periodontal research of University of Taubate
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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
18년 (성인)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
Inclusion Criteria:
- mild to moderate plaque related gingivitis (gingivitis group)
- mild to moderate periodontitis (periodontitis group)
- at least 20 natural teeth
- with no recognized systemic risk related to bacteremia
- no need for antibiotic prophylaxis before dental procedures
Exclusion Criteria:
- systemic diseases or other conditions that could influence the periodontal status;
- alcohol or other drugs abuse;
- orthodontic devices;
- extended prosthetic fixed devices, removable partial dentures or overhanging restorations;
- pregnancy or breast-feeding;
- history of sensitivity or suspected allergies following the use of chlorhexidine;
- antibiotics and/or anti-inflammatory drug use in the three months prior to the beginning of the study;
- regular use of chemotherapeutic antiplaque/antigingivitis products;
- any furcation lesions;
- periodontal treatment performed within six months prior to study initiation;
- unwillingness to return for follow-up.
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 네 배로
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: gingivitis mouth rinse
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Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds).
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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실험적: periodontitis mouth rinse
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Before local oral anesthesia and periodontal instrumentation individuals performed a single oral rinse (15mL of 0.12% chlorhexidine gluconate for 30 seconds).
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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활성 비교기: gingivitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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활성 비교기: periodontitis no mouth rinse
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Individuals only received local oral anesthesia before periodontal instrumentation.
Debridement procedures were carried out with manual Gracey and McCall curettes and Hirschfield files.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes on viable bacterial levels in blood
기간: 2 and 6 minutes
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To check a possible antimicrobial effect after a single mouth rinse use, the levels of viable anaerobic and aerobic bacterial cels were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes.
Blood samples were collected and spread out onto agar plates to determine total levels of aerobic and anaerobic bacteria.
Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.
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2 and 6 minutes
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Changes on levels of bacterial DNA in blood
기간: 2 and 6 months
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To check a possible antimicrobial effect after a single mouth rinse use, the levels of bacterial DNA in blood samples were compared between 0 and 2 minutes, 0 and 6 minutes and between 2 and 6 minutes.
Blood samples were collected and analyzed by real time PCR (polymerase chain reaction) to determine total bacterial load and levels of target periodontal pathogens.
Bacterial levels at 2 and 6 minutes were compared between volunteers who performed the pre-procedural rinse and who not.
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2 and 6 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
협력자
수사관
- 수석 연구원: Jose R Cortelli, PhD, University of Taubate
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
2013년 8월 1일
기본 완료 (실제)
2013년 12월 1일
연구 완료 (실제)
2013년 12월 1일
연구 등록 날짜
최초 제출
2014년 8월 8일
QC 기준을 충족하는 최초 제출
2014년 8월 11일
처음 게시됨 (추정)
2014년 8월 13일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2014년 8월 13일
QC 기준을 충족하는 마지막 업데이트 제출
2014년 8월 11일
마지막으로 확인됨
2014년 8월 1일
추가 정보
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