- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT02744417
Effect of Smoking Cessation on Clinical and Microbiological Outcomes of the Non-surgical Periodontal Therapy (EsCAPE2)
연구 개요
상태
정황
상세 설명
Smokers willing to quit, with 10 teeth or more, and with periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm) were enrolled in the study. All subjects received periodontal treatment and concurrent smoking cessation therapy. Smoking cessation therapy was performed by a team comprising physicians, nurses, a psychologist and dentists, and consisted of four 1-h counselling lectures, psychologist-assisted cognitive behavioral therapy, nicotine replacement therapy and medication (bupropion or varenicline). Smoking cessation motivation was reinforced by dentists at the maintenance sessions, by means of motivational interviewing techniques. Periodontal therapy consisted in full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors. Further, periodontal maintenance was performed every 3 months.
A single calibrated examiner, blinded to smoking status, assessed periodontal clinical outcomes (recession, pocket depth, clinical attachment level, plaque index and bleeding on probing). A structured questionnaire was applied in order to collect demographic and behavioral information. Expired carbon monoxide concentration was measured with a monoximeter, in order to validate smoking status. A pooled subgingival plaque sample was collected from the deepest periodontal pocket from each participant. The presence and quantification of Aggregatibacter actinomycetemcomitans, Porphyromonas gingivalis, Tannerella forsythia and Treponema denticola were determined using real time - PCR (RT-PCR).
연구 유형
등록 (실제)
단계
- 해당 없음
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- smokers willing to stop smoking
- >10 teeth
- periodontitis (30% or more of their teeth with proximal attachment loss ≥ 5 mm)
Exclusion Criteria:
- systemic conditions considered as risk factors for periodontal disease,
- periodontal therapy in the last 6 months
- continuous systemic use of anti-inflammatory or steroidal drugs
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
실험적: Smoking cessation therapy
Non-surgical periodontal therapy and concurrent smoking cessation therapy, with Smoking cessation counseling, Nicotine replacement therapy, use of bupropion hydrochloride and varenicline
|
Multidisciplinary smoking cessation counseling, performed by a team comprising physicians, nurses, a psychologist and dentists.
It consisted of four 1-h counselling lectures delivered by physicians, psychologist-assisted cognitive behavioural therapy, and counseling provided by dentists during the active phase of the treatment and maintenance session, using motivational interviewing techniques
Full-mouth supra and subgingival scaling and root planing (with curettes and ultrasonic scaler); oral hygiene instruction and motivation and removal of intra-oral plaque retentive factors
Nicotine replacement therapy: chewing gum (Nicorette chewing gum 2-4mg) and patches (Nicorette patches 15-25mg)
다른 이름들:
bupropion hydrochloride 150mg
다른 이름들:
Varenicline 0,5mg
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Clinical Attachment Level
기간: baseline - 12 months
|
Change in Clinical Attachment Level (millimeters) after 12 months
|
baseline - 12 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
Change in Gingival recession
기간: baseline - 12 months
|
Change in Gingival recession (millimeters) after 12 months
|
baseline - 12 months
|
Change in Pocket depth
기간: baseline - 12 months
|
Change in Pocket depth (millimeters) after 12 months
|
baseline - 12 months
|
Change in bleeding on probing
기간: baseline - 12 months
|
Change in bleeding on probing (percentage of sites with bleeding) after 12 months
|
baseline - 12 months
|
Change in visible plaque
기간: baseline - 12 months
|
Change in visible plaque (percentage of sites with visible plaque) after 12 months
|
baseline - 12 months
|
Prevalence and levels of Aggregatibacter actinomycetemcomitans
기간: baseline - 12 months
|
Prevalence and levels of Aggregatibacter actinomycetemcomitans determined by means of (RT-PCR).
|
baseline - 12 months
|
Prevalence and levels of Porphyromonas gingivalis
기간: baseline - 12 months
|
Prevalence and levels of Porphyromonas gingivalis, determined by means of (RT-PCR).
|
baseline - 12 months
|
Prevalence and levels of Tannerella forsythia
기간: baseline - 12 months
|
Prevalence and levels of Tanerella forsythia, determined by means of RT-PCR
|
baseline - 12 months
|
Prevalence and levels of Treponema denticola
기간: baseline - 12 months
|
Prevalence and levels of Treponema denticola, determined by means of RT-PCR
|
baseline - 12 months
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Claudio M Pannuti, PhD, University of Sao Paulo
간행물 및 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 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- EsCAPE2
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
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. .
Smoking cessation counseling에 대한 임상 시험
-
University Health Network, Toronto완전한