Intervention Study of Two Protocols for Non-surgical Treatment of Chronic Periodontitis
Approaches to Pocket/Root Debridement for Periodontal Infection Control - a Study on Effectiveness.
Treatment directed towards the control of periodontal infections is to about 90% non-surgical procedures. There is evidence from a large number of randomized controlled studies that the efficacy in terms of clinical outcomes of a full-mouth ultrasonic debridement approach (FMUD) is comparable to that of traditional section-wise scaling and root planing (SRP). A hypothesis for the current effectiveness study is that comparable clinical effects will be obtained with the FMUD approach as with conventional section-wise SRP, but with significantly more favourable patient-centred and health-economic outcomes.
This randomized study involves about 100 professionals (dental hygienists) and more than 850 patients at 40 dental clinics in the Vastra Gotaland Region, Sweden. The project not only evaluate treatment effects in terms of pertinent clinical outcomes, it also has a strong focus on patient-centered measures - patient-reported experience measures (PREM) and patient-reported outcome measures (PROM) - as well as health-economics.
연구 개요
상태
정황
상세 설명
All patients with chronic periodontitis (age 30 years and older) attending the selected Public Dental clinics in VG are eligible. The patients should have at least 8 teeth with pathological pockets (probing pocket depth ≥5 mm and bleeding on probing). Only patients providing signed informed consent are included.
Reported data in the study by Wennström et al. (J Clin Periodontol 2005) were used for power calculation. Thus, a total sample of 834 patients will provide a power of 95% at a significance level of p<0.05 to detect a difference of 5% in proportion of sites with "pocket closure" i.e. PPD ≤4 mm and BoP negative (primary efficacy variable) between treatment groups. For a power of 80% a total sample of 506 patients is required.
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Gothenburg, 스웨덴, SE 405 30
- Dept of periodontology, Institute of odontology, The Sahlgrenska academy at University of Gothenburg
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- chronic periodontitis
- at least 6 teeth with approximal probing pocket depth ≥5 mm and bleeding on probing
Exclusion Criteria:
- subgingival instrumentation within 6 months prior to screening examination
- compromised medical conditions requiring prophylactic antibiotic coverage
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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활성 비교기: Full-mouth ultrasonic debridement
Motivation and instruction in proper oral hygiene.
Before initiation of the subgingival debridement the patient must show sufficient self-performed infection control (full-mouth plaque score <30%).
One session of full-mouth ultrasonic pocket/root debridement using a piezoceramic ultrasonic instrument.
A follow-up visit after 2-4 weeks is scheduled for oral hygiene control and re-motivation/re-instruction if indicated.
At 3 and 6 months re-evaluation is performed and re-instrumentation of all sites showing a remaining probing pocket depth of ≥5 mm carried out.
Final evaluation at 18 months.
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Motivation and instruction in proper oral hygiene.
Before initiation of the subgingival debridement the patient must show sufficient self-performed infection control (full-mouth plaque score <30%).
One session of full-mouth ultrasonic pocket/root debridement using a piezoceramic ultrasonic instrument.
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활성 비교기: Section-wise scaling and root planing
Conventional treatment approach comprising motivation, oral hygiene instructions and section-wise scaling and root planing at required number of consecutive appointments with 1-2 week interval.
Follow-up 2-4 weeks after the last session of SRP for oral hygiene control and re-instruction if indicated.
At 3 and 6 months re-evaluation is performed and re-instrumentation of all sites showing a remaining pocket depth of ≥5 mm carried out.
Final evaluation at 18 months.
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Conventional treatment approach comprising motivation, oral hygiene instructions and section-wise scaling and root planing at required number of consecutive appointments with 1-2 week interval.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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"Periodontal pocket closure"
기간: Up to 18 months
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Frequency of sites with probing pocket depth (PPD) ≤4 mm and no bleeding
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Up to 18 months
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Probing pocket depth
기간: Up to 18 months
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Reduction in mean Probing pocket depth
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Up to 18 months
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Bleeding on pocket probing (BoP)
기간: Up to 18 months
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Reduction in frequency of bleeding on pocket probing (BoP)
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Up to 18 months
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Patient-reported outcome measures (PROM)
기간: Up to 18 months
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Questionnaire
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Up to 18 months
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Patient-reported experience measures (PREM)
기간: Up to 18 months
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Questionnaire
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Up to 18 months
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Investment for treatment
기간: Up to 18 months
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Individual investment for treatment - Direct and subsidiary costs
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Up to 18 months
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기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Plaque score
기간: Up to 18 months
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Percentage of tooth surfaces with bacterial deposits
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Up to 18 months
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Treatment time
기간: Up to 18 months
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Treatment time in minutes for mechanical instrumentation and oral hygiene instructions respectively
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Up to 18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Jan L Wennstrom, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- 연구 책임자: Maria Welander, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
- 연구 책임자: Kajsa H Abrahamsson, Dept of periodontology, Sahlgrenska academy, University of Gothenburg, Sweden
간행물 및 유용한 링크
일반 간행물
- Tomasi C, Liss A, Welander M, Alian AY, Abrahamsson KH, Wennstrom JL. A randomized multi-centre study on the effectiveness of non-surgical periodontal therapy in general practice. J Clin Periodontol. 2022 Nov;49(11):1092-1105. doi: 10.1111/jcpe.13703. Epub 2022 Jul 27.
- Liss A, Wennstrom JL, Welander M, Tomasi C, Petzold M, Abrahamsson KH. Patient-reported experiences and outcomes following two different approaches for non-surgical periodontal treatment: a randomized field study. BMC Oral Health. 2021 Dec 15;21(1):645. doi: 10.1186/s12903-021-02001-4.
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (예상)
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
기타 연구 ID 번호
- VGR 2013-2
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