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临床试验/NCT04023500
NCT04023500Unknown不适用

Supporting Oral Self-care of Patients With Periodontitis Through Brief Motivational Interview

University of Turku0 个研究点目标入组 28 人开始时间: 2014年5月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
28
主要终点
Bleeding on probing (BoP)

研究概览

简要总结

The aim of this study was to evaluate the potential additive effect of Motivational Interviewing (MI) on gingival health and self-care. Our hypothesis was that the Motivational Interviewing would result in improved gingival health and self-care compared to prevailing patient education.

详细描述

The study is designed as a randomized, double-blinded, controlled clinical trial of 6-month duration involving patients with diagnosed periodontitis. The subjects are randomized to intervention or control group using the randomizing list.

For both groups, necessary non-surgical periodontal treatments will be done. In the intervention group The MI-intervention is used as a part of normal dental hygienist appointment and if patient need more than one visit, MI was used in every visit.

In control group prevailing, more professional-centered education is used. Dental hygienist define patients educational needs and give direct instructions how to change behaviour and self-care.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

盲法说明

Double-blinded, patients and dentist who performs baseline and follow-up measurements.

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults, over 18-year-old
  • CPI (Community periodontal index) 3 in at least two sextants and
  • Diagnosed parodontitis
  • The previous treatment period should have been more than one year ago.

排除标准

  • pregnancy (or the planning of pregnancy)
  • immunosuppressive illness or a medication,
  • hepatitis, HIV, MRSA (methicillin-resistant Staphylococcus aureus)
  • a bleeding illness or a anticoagulant (excluding primalan 100-200 mg / a day)
  • the labile diabetes
  • cytotoxic treatment
  • a need for the antibiotic prophylaxis.

结局指标

主要结局

Bleeding on probing (BoP)

时间窗: Up to 6 month

Change in BoP is measured three times during the study. In the baseline and in the tree- and six-months follow-up. Bop is recorded60 seconds after the pocket probing and assessed as present (1) or absent (0) on four surfaces.

Pocket probing depth (PD)

时间窗: Up to 6 month

Change in PD is measured three times during the study. In the baseline and in the tree- and six-months follow-up. PD is measured at mesial, distal, lingual and buccal surfaces.

Clinical Attachment Level (CAL)

时间窗: Up to 6 month

Change in CAL is measured three times during the study. In the baseline and in the tree- and six-months follow-up. CAL is measured if cemento-enamel junction is uncovered or if there is 6 mm deep or deeper gingival pocket.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mirkka Järvinen

Principal investigator

University of Turku

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