- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01046435
Effects of Periodontal Therapy on Systemic Inflammation
Effects of Periodontal Therapy on Markers of Systemic Inflammation in Subjects at Cardiovascular Disease Risk
연구 개요
상세 설명
Aims: To determine the effects of periodontal treatment on systemic markers of inflammation in subjects with risk of coronary heart disease.
Methods: The current study is a randomized, double blind clinical trial, with two treatment groups.
Eligible participants will be allocated by restricted randomization using the minimization method to the treatment group or to the control group. The treatment group will receive periodontal therapy consisting of instructions of plaque control, supra and subgingival scaling and root planing, oral systemic metronidazole (250 mg) plus amoxicillin (500 mg) tid for 7 days. The control group will receive plaque control instructions, supragingival scaling and two placebos. The study plan to enroll 160 participants, 80 in ech arm, over a 6-month period. Follow-up clinic visits will be scheduled to occur every 3 months after finishing treatment. Baseline and follow-up clinic visits will include periodontal examination, blood collection and medical and dental histories. The following biochemical markers will be determined at baseline and at 3, 6, 9 and 12 months posttherapy: total, LDL and HDL lipoprotein cholesterol and triglycerides, glycemia, high sensitivity C-reactive protein, fibrinogen, erythrocyte sedimentation rate and white blood cells count. In diabetic patients, glycosylated hemoglobin will be also assessed.
The study will be conducted in a public health center in Santiago, Chile. To be eligible for the study, participants have to be older than 35 years and fulfill the medical and periodontal criteria. For the medical criteria participants have to have dyslipidemia, and at least one of the following coronary heart disease risk factors: obesity, smoking, diabetes, hypertension.
The periodontal inclusion criteria are: no history of periodontal treatment, the presence of at least 14 natural teeth, with at least 4 teeth with interproximal sites with probing depth equal or higher than 4 mm and concomitant attachment loss equal or higher than 3 mm, and >30 % of sites with bleeding on probing.
The outcomes measures will be levels of serum C-reactive protein, fibrinogen, erythrosedimentation rate, white blood cell count.The outcomes will be measured at 0, 3,6,9, and 6 months after periodontal therapy.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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-
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Santiago, 칠레
- Dra Eloisa Díaz Health Center, Metropolitan Northen Health Service
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Clinically diagnosis of marginal periodontitis
- No history of periodontal treatment
- At least 14 natural teeth present
- Dyslipidemia
And at least one of the following factors:
- obesity
- diabetes
- smoking, hypertension
Exclusion Criteria:
- Rheumatoid arthritis
- Any type of cancer in the previous 2 years
- Pregnancy and lactation
- Indication of the use of antibiotic for invasive procedures
- Use of antibiotics in previous three months.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 삼루타
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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위약 비교기: Supragingival scaling plus placebo
Plaque control instructions, supra gingival scaling and two placebos
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Metronidazole 250 mg three times a day per 7 days
다른 이름들:
Two placebos 3 times a day for 7 days
다른 이름들:
|
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실험적: Root planing plus antibiotics
Plaque control instructions, subgingival scaling,root planing, metronidazole 250 mg and amoxicillin 500 mg.
three times a day for 7 days
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Metronidazole 250 mg three times a day per 7 days
다른 이름들:
Two placebos 3 times a day for 7 days
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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Serum levels of C-reactive protein, fibrinogen,erythrosedimentation rate and white blood cell count
기간: 0, 3, 6, 9 and 12 months after therapy
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0, 3, 6, 9 and 12 months after therapy
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2차 결과 측정
결과 측정 |
기간 |
|---|---|
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Clinical periodontal parameters: probing depth, bleeding on probing, clinical attachment level
기간: 0, 3, 6, 9 and 12 months after therapy
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0, 3, 6, 9 and 12 months after therapy
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공동 작업자 및 조사자
수사관
- 수석 연구원: Nestor J. Lopez, DDS, University of Chile
- 수석 연구원: Antonio Quintero, DDS, University of Chile
- 연구 의자: Carola Ibieta, DDS, University of Chile
- 연구 의자: Carlos Y Valenzuela, DMS, PhD, University of Chile
- 연구 의자: Lilian Jara, MsB, PhD, University of Chile
- 연구 의자: Marcelo Llancaqueo, DMS, University of Chile
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
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. .
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