- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT05120206
The Impact of Cigarette Smoking on Periodontal Therapy
Outcomes of Periodontal Therapy in Smokers and Non-smokers With Chronic Periodontitis
연구 개요
상태
상세 설명
The overall aim of this work was to study clinical outcomes of active and supportive periodontal therapy in smokers and non-smokers with chronic periodontitis at patient, tooth, and site level. Moreover, to compare the periopathogenic microflora and inflammatory markers in gingival crevicular fluid and in blood in smokers and non-smokers following therapy.
Eighty patients, 40 smokers and 40 non-smokers, with moderate to severe chronic periodontitis were included in this prospective cohort study and treated non-surgically and surgically, and then followed-up in a supportive periodontal therapy program for 12 months. Smoking status was validated measuring serum cotinine levels at pre-treatment and 12 months following supportive periodontal therapy.
Clinical measurements included full mouth recordings of clinical attachment level, probing depth, bleeding on probing, and plaque index at pre-treatment and following active and supportive periodontal therapy. At the same timepoints, subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization. Blood samples (PAXgeneBlood), serum, gingval crevicular fluid were also collected at the three timepoints.
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- healthy subjects
- age 35-75 years
- diagnosed with chronic periodontitis
- at least four non-adjacent teeth with proximal sites with a PD ≥6 mm and clinical attachment loss ≥5 mm with BoP and no radiographic signs of apical pathology.
- either smokers (>10 cigarettes per day for at least 5 years) or non-smokers (never smoked or not within the last 5 years).
Exclusion Criteria:
- subjects who presented with any current medical condition or used medications known to affect periodontal healing
- incorrectly reported smoking status
- use of antibiotics within 6 months of the study
- received subgingival scaling within 6 months of the study
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: Cigarette smokers with periodontitis
Periodontal therapy in cigarette smokers
|
Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
다른 이름들:
|
|
활성 비교기: Non-smokers with periodontitis
Periodontal therapy in non-smokers
|
Non-surgical and surgical periodontal therapy in cigarette smokers and non-smokers
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
PD ≥5 mm with BoP
기간: 24 months
|
Corrected for clustering within patients, teeth, and sites over time, was the unit of the analysis and PD ≥5 mm with BoP was the outcome (dependent variable) dichotomized as present (1) or absent (0).
|
24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Teeth present
기간: 24 months
|
Number of teeth
|
24 months
|
|
Clinical periodontal attachmentloss
기간: 24 months
|
Clinical attachment loss in mm
|
24 months
|
|
Periodontal pocket depth
기간: 24 months
|
Probing depth in mm
|
24 months
|
|
Bleeding at site level
기간: 24 months
|
Bleeding on probing (yes or no)
|
24 months
|
|
Bleeding at patient level
기간: 24 months
|
Bleeding index in percentage (%)
|
24 months
|
|
Plaque at patient level
기간: 24 months
|
Plaque index in percentage (%)
|
24 months
|
|
Amount of periopathogenic bacteria
기간: 24 months
|
Subgingival plaque samples of 20 subgingival periopathogenic bacterial species were analysed using checkerboard DNA-DNA hybridization.
|
24 months
|
|
Inflammatory gingival crevicular fluid markers (proteins)
기간: 24 months
|
Concentrations of gingival crevicular fluid biomarkers measured in pg/mLwere analysed using multiplex and singleplex micro-bed immunoassays.
|
24 months
|
|
Serum proteins
기간: 24 months
|
Concentration of inflammatory serum markers measured in pg/ɥL determined using multiplex kit Bio-Plex Human ProTM Assay.
|
24 months
|
|
Gene expression in blood
기간: 24 months
|
Inflammatory gene (RNA) expression levels is estimated by counting the reads that map to genes or exones using the the RPKM (Reads per Kilobases per Million reads) methods.
|
24 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Dagmar F. Bunæs, PhD, Department of Clinical Dentistry - Periodontics, University of Bergen, NORWAY
간행물 및 유용한 링크
일반 간행물
- Bunaes DF, Lie SA, Enersen M, Aastrom AN, Mustafa K, Leknes KN. Site-specific treatment outcome in smokers following non-surgical and surgical periodontal therapy. J Clin Periodontol. 2015 Oct;42(10):933-42. doi: 10.1111/jcpe.12462. Epub 2015 Oct 28.
- Bunaes DF, Mustafa M, Mohamed HG, Lie SA, Leknes KN. The effect of smoking on inflammatory and bone remodeling markers in gingival crevicular fluid and subgingival microbiota following periodontal therapy. J Periodontal Res. 2017 Aug;52(4):713-724. doi: 10.1111/jre.12438. Epub 2017 Mar 17.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
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
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